Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04057820
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2019-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004435', 'term': 'Eating'}, {'id': 'D012890', 'term': 'Sleep'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stounpraseuth@uams.edu', 'phone': '5016867233', 'title': 'Dr. Songthip Ounpraseuth', 'organization': 'University of Arkansas for Medical Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3-months post-hospital discharge', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.', 'otherNumAtRisk': 702, 'deathsNumAtRisk': 702, 'otherNumAffected': 8, 'seriousNumAtRisk': 702, 'deathsNumAffected': 4, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.', 'otherNumAtRisk': 603, 'deathsNumAtRisk': 603, 'otherNumAffected': 18, 'seriousNumAtRisk': 603, 'deathsNumAffected': 0, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Severe Weight Loss', 'notes': 'AE during main study in-hospital prior to discharge.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Accidental trauma (infant dropped)', 'notes': 'AE during main study in-hospital prior to discharge.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Jaundice', 'notes': 'AE during main study in-hospital prior to discharge.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'CMV', 'notes': 'AE during main study in-hospital prior to discharge.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fall, caught before hitting floor', 'notes': 'AE during main study in-hospital prior to discharge.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diaper Dermatitis', 'notes': 'AE during main study after hospital discharge.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-accidental trauma', 'notes': 'AE during main study after hospital discharge.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'PCP suspected resp. distress, not confirmed by ED', 'notes': 'AE during main study after hospital discharge.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Frequent emesis', 'notes': 'AE during main study after hospital discharge.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Neonatal sleep myoclonus', 'notes': 'AE during main study after hospital discharge.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Attention to g-tube', 'notes': 'AE during main study after hospital discharge.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Seizure', 'notes': 'SAE during main study in-hospital prior to discharge.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Severe Weight Loss', 'notes': 'SAE during main study in-hospital prior to discharge.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Accidental trauma (infant dropped)', 'notes': 'SAE during main study in-hospital prior to discharge.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Respiratory insufficiency', 'notes': 'SAE reported after discharge from hospital.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Accidental Drug Ingestion', 'notes': 'SAE reported after discharge from hospital.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Failure to thrive', 'notes': 'SAE reported after discharge from hospital.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Poor weight gain', 'notes': 'SAE reported after discharge from hospital.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abnormal echocardiogram', 'notes': 'SAE reported after discharge from hospital.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute Covid-19', 'notes': 'SAE reported after discharge from hospital.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tachypnea required readmission to hospital', 'notes': 'SAE reported after discharge from hospital.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ventricular Septal Defect', 'notes': 'SAE reported after discharge from hospital.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Viral Meningitis', 'notes': 'SAE reported after discharge from hospital.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting R11.10', 'notes': 'SAE reported after discharge from hospital.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Observation and evaluation of newborn sepsis', 'notes': 'SAE reported after discharge from hospital.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Severe Weight Loss', 'notes': 'SAE reported after discharge from hospital.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time From Birth Until Medically Ready for Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '440', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.'}, {'id': 'OG001', 'title': 'Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '16.7'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '9.2'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence rate ratio (IRR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.46', 'ciUpperLimit': '0.65', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'from date of birth until hospital discharge or 1 year whichever comes first', 'description': 'The number of days from birth until the infant is determined to be medically ready for discharge per protocol. The criteria for medical readiness were prospectively defined as an age of at least 96 hours, a period of at least 48 hours without receipt of an opioid, at least 24 hours with no respiratory support and with 100% oral feeding, and at least 24 hours from initiation of maximum caloric density.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population only included those infants that met the definition of medically ready for discharge.'}, {'type': 'SECONDARY', 'title': 'Did Infant Receive Opioid Replacement Therapy (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.'}, {'id': 'OG001', 'title': 'Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.'}], 'classes': [{'categories': [{'measurements': [{'value': '328', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.47', 'statisticalMethod': 'Mixed-effect Poisson w/ robust err var', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of birth until hospital discharge or 1 year whichever comes first', 'description': 'Review of hospital records to determine if infant received opioid replacement therapy prior to hospital discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Dose of Opioid Replacement Therapy Infant Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.'}, {'id': 'OG001', 'title': 'Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '10.1'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '7.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '4.9', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From date of birth until hospital discharge or 1 year whichever comes first', 'description': 'If infant received opioid replacement therapy, the units received (mg/kg).', 'unitOfMeasure': 'mg/kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome include only infants who received opioid treatment.'}, {'type': 'SECONDARY', 'title': 'Time Until Initiation of Opioid Replacement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.'}, {'id': 'OG001', 'title': 'Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.0', 'groupId': 'OG000', 'lowerLimit': '48.7', 'upperLimit': '57.3'}, {'value': '76', 'groupId': 'OG001', 'lowerLimit': '63.0', 'upperLimit': '89.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.0', 'ciLowerLimit': '8.1', 'ciUpperLimit': '37.9', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From date of birth until hospital discharge or 1 year whichever comes first', 'description': 'If infant received opioid replacement therapy, the timing of the initiation of therapy', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome include only infants who received opioid treatment.'}, {'type': 'SECONDARY', 'title': 'Receipt of Adjuvant Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.'}, {'id': 'OG001', 'title': 'Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '30.4'}, {'value': '15.7', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '25.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.37', 'ciUpperLimit': '1.76', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'from date of birth until hospital discharge or 1 year whichever comes first', 'description': 'To see if the infant had to have any other type of therapy for NOWS (yes/no)', 'unitOfMeasure': 'percentage who received adjuvant therapy', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome include only infants who received opioid treatment.'}, {'type': 'SECONDARY', 'title': 'Maximum Percent Change in Weight During Initial Birth Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.'}, {'id': 'OG001', 'title': 'Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '8.0'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '8.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '1.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'from date of birth until hospital discharge or 1 year whichever comes first', 'description': 'Assess percent change in birthweight during hospitalization (i.e., \\[minimum weight - birth weight\\] / birth weight)', 'unitOfMeasure': 'percentage of change in birth weight', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Feeding Type at Discharge (Exclusive Maternal Breast Milk)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.'}, {'id': 'OG001', 'title': 'Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '9.8'}, {'value': '12.1', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '17.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.94', 'ciLowerLimit': '0.94', 'ciUpperLimit': '3.99', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'from date of birth until hospital discharge or 1 year whichever comes first', 'description': 'Exclusive maternal breast milk feeding at the time of hospital discharge', 'unitOfMeasure': 'percentage of exclusive breast milk', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Any Direct Breast Feeding at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.'}, {'id': 'OG001', 'title': 'Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '23.7'}, {'value': '32.7', 'groupId': 'OG001', 'lowerLimit': '23.2', 'upperLimit': '42.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '1.13', 'ciUpperLimit': '2.48', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'within 24 hours of hospital discharge', 'description': 'Direct breastfeeding within 24 hours of hospital discharge (yes/no)', 'unitOfMeasure': 'percentage of direct breast feeding', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.'}, {'id': 'OG001', 'title': 'Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '15.3'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '8.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence ratio ratio (IRR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.64', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'from date of birth until hospital discharge or 1 year whichever comes first', 'description': 'Time from birth until infants being managed for NOWS are discharged from the hospital', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.'}, {'id': 'OG001', 'title': 'Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from date of birth until hospital discharge or 1 year whichever comes first', 'description': 'composite of the following: seizures, accidental trauma, respiratory insufficiency due to opioid therapy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.'}, {'id': 'OG001', 'title': 'Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.'}], 'classes': [{'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.47', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 3 months of age', 'description': 'Outpatient composite safety outcome which includes acute/urgent care and/or emergency room visits, hospital readmissions at 3 months (present/absent)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Critical Safety Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.'}, {'id': 'OG001', 'title': 'Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 3 months of age.', 'description': 'any non-accidental trauma and death (yes/no)', 'unitOfMeasure': 'number of non-accidental trauma/death', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Block 1: Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.\n\nBlock 1 contained four sites.'}, {'id': 'FG001', 'title': 'Block 1: Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.\n\nBlock 1 had four sites.'}, {'id': 'FG002', 'title': 'Block 2: Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.\n\nBlock 2 contained two sites.'}, {'id': 'FG003', 'title': 'Block 2: Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.\n\nBlock 2 had two sites.'}, {'id': 'FG004', 'title': 'Block 3: Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.\n\nBlock 3 contained three sites.'}, {'id': 'FG005', 'title': 'Block 3: Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.\n\nBlock 3 had three sites.'}, {'id': 'FG006', 'title': 'Block 4: Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.\n\nBlock 4 contained three sites.'}, {'id': 'FG007', 'title': 'Block 4: Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.\n\nBlock 4 had threesites.'}, {'id': 'FG008', 'title': 'Block 5: Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.\n\nBlock 5 contained four sites.'}, {'id': 'FG009', 'title': 'Block 5: Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.\n\nBlock 5 had four sites.'}, {'id': 'FG010', 'title': 'Block 6: Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.\n\nBlock 6 contained four sites.'}, {'id': 'FG011', 'title': 'Block 6: Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.\n\nBlock 6 had four sites.'}, {'id': 'FG012', 'title': 'Block 7: Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.\n\nBlock 7 contained threesites.'}, {'id': 'FG013', 'title': 'Block 7: Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.\n\nBlock 7 had three sites.'}, {'id': 'FG014', 'title': 'Block 8: Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.\n\nBlock 8 contained threesites.'}, {'id': 'FG015', 'title': 'Block 8: Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.\n\nBlock 8 had three sites.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '27'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '8'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '23'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '3', 'numSubjects': '23'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '4', 'numSubjects': '41'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '4', 'numSubjects': '27'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '3', 'numSubjects': '16'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '3', 'numSubjects': '20'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '27'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '8'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '23'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '3', 'numSubjects': '23'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '4', 'numSubjects': '41'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '4', 'numSubjects': '27'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '3', 'numSubjects': '16'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '3', 'numSubjects': '20'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Block 1 with 4 sites transitioned from Usual Care to ESC during Period 2; therefore no infants were being enrolled and the total number of sites enrolling infants was 22.\n\nFor this stepped wedge study design, a new cohort of infants is enrolled during each period except the transition period. Therefore, the number of infants to start a period is unlikely to equal the number of infants who completed the previous period.', 'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'comment': 'For this stepped wedge study design, a new cohort of infants is enrolled during each period except the transition period. Therefore, the number of infants to start a period is unlikely to equal the number of infants who completed the previous period.', 'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '5'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '11'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '3', 'numSubjects': '12'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '4', 'numSubjects': '47'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '4', 'numSubjects': '17'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '3', 'numSubjects': '10'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '3', 'numSubjects': '18'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '5'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '11'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '3', 'numSubjects': '12'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '4', 'numSubjects': '47'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '4', 'numSubjects': '17'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '3', 'numSubjects': '10'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '3', 'numSubjects': '18'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'comment': 'For this stepped wedge study design, a new cohort of infants is enrolled during each period except the transition period. Therefore, the number of infants to start a period is unlikely to equal the number of infants who completed the previous period.', 'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '25'}, {'comment': 'Block 2 with 2 sites transitioned from Usual Care to ESC during Period 3; therefore no infants were being enrolled and the total number of sites enrolling infants was 24..', 'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '7'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '3', 'numSubjects': '19'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '4', 'numSubjects': '32'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '4', 'numSubjects': '15'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '3', 'numSubjects': '22'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '3', 'numSubjects': '24'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '25'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '7'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '3', 'numSubjects': '19'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '4', 'numSubjects': '32'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '4', 'numSubjects': '15'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '3', 'numSubjects': '22'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '3', 'numSubjects': '24'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'comment': 'For this stepped wedge study design, a new cohort of infants is enrolled during each period except the transition period. Therefore, the number of infants to start a period is unlikely to equal the number of infants who completed the previous period.', 'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '22'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '8'}, {'comment': 'Block 3 with 3 transitioned from Usual Care to ESC during Period 4; therefore no infants were being enrolled and the total number of sites enrolling infant was 23.', 'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '3', 'numSubjects': '16'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '4', 'numSubjects': '33'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '4', 'numSubjects': '19'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '3', 'numSubjects': '19'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '3', 'numSubjects': '22'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '22'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '8'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '3', 'numSubjects': '16'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '4', 'numSubjects': '33'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '4', 'numSubjects': '19'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '3', 'numSubjects': '19'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '3', 'numSubjects': '22'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Period 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'comment': 'For this stepped wedge study design, a new cohort of infants is enrolled during each period except the transition period. Therefore, the number of infants to start a period is unlikely to equal the number of infants who completed the previous period.', 'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '25'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '8'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '3', 'numSubjects': '12'}, {'comment': 'Block 4 with 3 sites transitioned from Usual Care to ESC during Period 5; therefore no infants were being enrolled and the total number of sites enrolling infants was 23.', 'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '4', 'numSubjects': '16'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '4', 'numSubjects': '19'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '3', 'numSubjects': '16'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '3', 'numSubjects': '17'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '25'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '8'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '3', 'numSubjects': '12'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '4', 'numSubjects': '16'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '4', 'numSubjects': '19'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '3', 'numSubjects': '16'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '3', 'numSubjects': '17'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Period 6', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'comment': 'For this stepped wedge study design, a new cohort of infants is enrolled during each period except the transition period. Therefore, the number of infants to start a period is unlikely to equal the number of infants who completed the previous period.', 'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '24'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '5'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '3', 'numSubjects': '14'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '3', 'numSubjects': '15'}, {'comment': 'Block 5 with 4 sites transitioned from Usual Care to ESC during Period 6; therefore no infants were being enrolled and the total number of sites enrolling infants was 22.', 'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '4', 'numSubjects': '13'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '3', 'numSubjects': '17'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '3', 'numSubjects': '18'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '24'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '5'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '3', 'numSubjects': '14'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '3', 'numSubjects': '15'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '4', 'numSubjects': '13'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '3', 'numSubjects': '17'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '3', 'numSubjects': '18'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Period 7', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '24'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '9'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '3', 'numSubjects': '14'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '3', 'numSubjects': '15'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '4', 'numSubjects': '34'}, {'comment': 'Block 6 with 4 sites transitioned from Usual Care to ESC during Period 7; therefore no infants were being enrolled and the total number of sites enrolling infants was 22.', 'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '3', 'numSubjects': '12'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '3', 'numSubjects': '19'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '24'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '9'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '3', 'numSubjects': '14'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '3', 'numSubjects': '15'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '4', 'numSubjects': '34'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '3', 'numSubjects': '12'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '3', 'numSubjects': '19'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Period 8', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'comment': 'For this stepped wedge study design, a new cohort of infants is enrolled during each period except the transition period. Therefore, the number of infants to start a period is unlikely to equal the number of infants who completed the previous period.', 'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '21'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '10'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '3', 'numSubjects': '14'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '3', 'numSubjects': '18'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '4', 'numSubjects': '32'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '4', 'numSubjects': '9'}, {'comment': 'Block 7 with 3 sites transitioned from Usual Care to ESC during Period 8; therefore no infants were being enrolled and the total number of sites enrolling infants was 23.', 'groupId': 'FG012', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '3', 'numSubjects': '22'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '21'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '10'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '3', 'numSubjects': '14'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '3', 'numSubjects': '18'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '4', 'numSubjects': '32'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '4', 'numSubjects': '9'}, {'groupId': 'FG012', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '3', 'numSubjects': '22'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Period 9', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'comment': 'For this stepped wedge study design, a new cohort of infants is enrolled during each period except the transition period. Therefore, the number of infants to start a period is unlikely to equal the number of infants who completed the previous period.', 'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '18'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '3'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '3', 'numSubjects': '5'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '3', 'numSubjects': '17'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '4', 'numSubjects': '28'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '4', 'numSubjects': '15'}, {'groupId': 'FG012', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG013', 'numUnits': '3', 'numSubjects': '14'}, {'comment': 'Block 8 with 3 sites transitioned from Usual Care to ESC during Period 9; therefore no infants were being enrolled and the total number of sites enrolling infants was 23.', 'groupId': 'FG014', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '18'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '3'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '3', 'numSubjects': '5'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '3', 'numSubjects': '17'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '4', 'numSubjects': '28'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '4', 'numSubjects': '15'}, {'groupId': 'FG012', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG013', 'numUnits': '3', 'numSubjects': '14'}, {'groupId': 'FG014', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Period 10', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'comment': 'For this stepped wedge study design, a new cohort of infants is enrolled during each period except the transition period. Therefore, the number of infants to start a period is unlikely to equal the number of infants who completed the previous period.', 'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '26'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '8'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '3', 'numSubjects': '17'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '3', 'numSubjects': '7'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '4', 'numSubjects': '32'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '4', 'numSubjects': '17'}, {'groupId': 'FG012', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG013', 'numUnits': '3', 'numSubjects': '23'}, {'groupId': 'FG014', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG015', 'numUnits': '3', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '26'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '8'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '3', 'numSubjects': '17'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '3', 'numSubjects': '7'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '4', 'numSubjects': '32'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '4', 'numSubjects': '17'}, {'groupId': 'FG012', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG013', 'numUnits': '3', 'numSubjects': '23'}, {'groupId': 'FG014', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG015', 'numUnits': '3', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG007', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG008', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG009', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG010', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG011', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG012', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG013', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG014', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG015', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Sites', 'recruitmentDetails': 'The in-hospital and initial follow-up portions of the trial were conducted with a waiver of informed consent, as approved by central institutional review board.', 'preAssignmentDetails': 'The in-hospital portion of the study was performed under waiver of informed consent. Only the newborn babies are considered enrolled participants. The number of participants to start a Period may not equal the number who completed a previous Period because at each subsequent Period a new cohort of newborn babies are enrolled at the respective sites. During the transition period for a given block, sites within the block are not enrolling participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)\n\nFinnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.'}, {'id': 'BG001', 'title': 'Eat, Sleep, Console Care Tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool\n\nEat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'BG000'}, {'value': '601', 'groupId': 'BG001'}, {'value': '1292', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30.4', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '31.0', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '30.7', 'spread': '4.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This information represents maternal age.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'There were 11 observations with missing maternal age in the Usual Care group while the ESC group had 2 missing maternal age values.'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38.6', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '38.6', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Gestational age at birth', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '336', 'groupId': 'BG000'}, {'value': '314', 'groupId': 'BG001'}, {'value': '650', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '366', 'groupId': 'BG000'}, {'value': '289', 'groupId': 'BG001'}, {'value': '655', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "This information represents the infant's sex.", 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '576', 'groupId': 'BG000'}, {'value': '538', 'groupId': 'BG001'}, {'value': '1114', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '555', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '1035', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Marital Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Married', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Single', 'measurements': [{'value': '582', 'groupId': 'BG000'}, {'value': '492', 'groupId': 'BG001'}, {'value': '1074', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gravidity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1304', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '4', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Pregnancies', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'There was one observation in the Usual Care group with missing gravidity value.'}, {'title': 'Parity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1304', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Births', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'There was one observation in the Usual Care group with missing parity value.'}, {'title': 'Highest Level of Education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}], 'categories': [{'title': '8th grade or less', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '9th grade to 12th grade', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'High school diploma', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}, {'title': "Partial college or Associate's degree", 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'College degree', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Trade or Technical School', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Graduate degree', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '420', 'groupId': 'BG000'}, {'value': '386', 'groupId': 'BG001'}, {'value': '806', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Mother's Medical Insurance", 'classes': [{'title': 'Public Insurance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '633', 'groupId': 'BG000'}, {'value': '521', 'groupId': 'BG001'}, {'value': '1154', 'groupId': 'BG002'}]}]}, {'title': 'Private', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}, {'title': 'Self-pay/uninsured', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Medical insurance is a check "all that applies" question; therefore, the total number may exceed the group sample size.', 'unitOfMeasure': 'participants'}, {'title': 'Infant weight at birth', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}, {'value': '603', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3026.4', 'spread': '445.4', 'groupId': 'BG000'}, {'value': '3012.8', 'spread': '490.4', 'groupId': 'BG001'}, {'value': '3020.1', 'spread': '471.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Head circumference at birth', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '692', 'groupId': 'BG000'}, {'value': '591', 'groupId': 'BG001'}, {'value': '1283', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.4', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '33.5', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '33.4', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Infant head circumference at birth', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'In the Usual Care group, 10 infants had missing head circumference values while 12 infants had missing observations in the ESC group.'}, {'title': 'Length at birth', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'BG000'}, {'value': '596', 'groupId': 'BG001'}, {'value': '1294', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48.8', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '48.8', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '48.8', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "This represents the infant's length at birth.", 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'There were 4 infants in the Usual Care group with missing length at birth while 7 infants in the ESC group had missing observations.'}, {'title': '1-minute Apgar scores', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '689', 'groupId': 'BG000'}, {'value': '594', 'groupId': 'BG001'}, {'value': '1283', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000', 'lowerLimit': '8', 'upperLimit': '8'}, {'value': '8', 'groupId': 'BG001', 'lowerLimit': '8', 'upperLimit': '8'}, {'value': '8', 'groupId': 'BG002', 'lowerLimit': '8', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Apgar stands for Appearance, Pulse, Grimace, Activity and Respiration with 5 categories (breathing effort, heart rate, muscle tone, reflexes, skin color) each measured on a scale of 0, 1, 2 (range 0 to 10 with higher scores representing better outcome).\n\nThe 1-minute evaluation is used to determine how well the infant tolerated the birthing process.\n\nThere were 13 infants with missing 1-min Apgar scores in the Usual Care group while 9 infants had missing observations in the ESC group.'}, {'title': '5-minute Apgar scores', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'BG000'}, {'value': '596', 'groupId': 'BG001'}, {'value': '1284', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '9'}, {'value': '9', 'groupId': 'BG001', 'lowerLimit': '9', 'upperLimit': '9'}, {'value': '9', 'groupId': 'BG002', 'lowerLimit': '9', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': "Apgar stands for Appearance, Pulse, Grimace, Activity and Respiration with 5 categories (breathing effort, heart rate, muscle tone, reflexes, skin color) each measured on a scale of 0, 1, 2 (range 0 to 10 with higher scores representing better outcome).\n\nThe 5-minute score measures how well the infant is doing outside the mother's womb.\n\nThere were 14 infants with missing 5-min Apgar scores in the Usual Care group while 7 infants had missing observations in the ESC group."}, {'title': '10-minute Apgar scores', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000', 'lowerLimit': '8', 'upperLimit': '9'}, {'value': '9', 'groupId': 'BG001', 'lowerLimit': '8', 'upperLimit': '9'}, {'value': '8', 'groupId': 'BG002', 'lowerLimit': '8', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Apgar stands for Appearance, Pulse, Grimace, Activity and Respiration with 5 categories (breathing effort, heart rate, muscle tone, reflexes, skin color) each measured on a scale of 0, 1, 2 (range 0 to 10 with higher scores representing better outcome).\n\nThe Usual Care group had 668 infants with missing 10-min Apgar scores while ESC had 574 missing 10-min Apgar scores.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-28', 'size': 1027380, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-06T14:19', 'hasProtocol': True}, {'date': '2020-03-09', 'size': 252838, 'label': 'Informed Consent Form: General Consent', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-06T14:21', 'hasProtocol': False}, {'date': '2020-03-09', 'size': 270246, 'label': 'Informed Consent Form: Consent for parent and minor mother', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-06T14:22', 'hasProtocol': False}, {'date': '2021-02-18', 'size': 274047, 'label': 'Informed Consent Form: Consent for caregiver only', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-06T14:23', 'hasProtocol': False}, {'date': '2021-01-11', 'size': 273694, 'label': 'Informed Consent Form: Consent for baby only', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_004.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-06T14:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The protocol study team will assure blinding of the electronically performed follow-up questionnaires through the use of a centralized computer scoring system. However, it will not be possible to blind responses to questionnaires that are performed with the assistance of research personnel at the participating sites. The protocol study team will note the method of questionnaire completion and will evaluate for bias in this context.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Stepped-wedge cluster randomized controlled trial with transition period.All sites start with usual care and are transitioned to using the ESC tool'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1305}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2019-08-09', 'resultsFirstSubmitDate': '2023-05-05', 'studyFirstSubmitQcDate': '2019-08-13', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-11', 'studyFirstPostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time From Birth Until Medically Ready for Discharge', 'timeFrame': 'from date of birth until hospital discharge or 1 year whichever comes first', 'description': 'The number of days from birth until the infant is determined to be medically ready for discharge per protocol. The criteria for medical readiness were prospectively defined as an age of at least 96 hours, a period of at least 48 hours without receipt of an opioid, at least 24 hours with no respiratory support and with 100% oral feeding, and at least 24 hours from initiation of maximum caloric density.'}], 'secondaryOutcomes': [{'measure': 'Did Infant Receive Opioid Replacement Therapy (Yes/no)', 'timeFrame': 'From date of birth until hospital discharge or 1 year whichever comes first', 'description': 'Review of hospital records to determine if infant received opioid replacement therapy prior to hospital discharge'}, {'measure': 'Total Dose of Opioid Replacement Therapy Infant Received', 'timeFrame': 'From date of birth until hospital discharge or 1 year whichever comes first', 'description': 'If infant received opioid replacement therapy, the units received (mg/kg).'}, {'measure': 'Time Until Initiation of Opioid Replacement', 'timeFrame': 'From date of birth until hospital discharge or 1 year whichever comes first', 'description': 'If infant received opioid replacement therapy, the timing of the initiation of therapy'}, {'measure': 'Receipt of Adjuvant Therapy', 'timeFrame': 'from date of birth until hospital discharge or 1 year whichever comes first', 'description': 'To see if the infant had to have any other type of therapy for NOWS (yes/no)'}, {'measure': 'Maximum Percent Change in Weight During Initial Birth Hospitalization', 'timeFrame': 'from date of birth until hospital discharge or 1 year whichever comes first', 'description': 'Assess percent change in birthweight during hospitalization (i.e., \\[minimum weight - birth weight\\] / birth weight)'}, {'measure': 'Feeding Type at Discharge (Exclusive Maternal Breast Milk)', 'timeFrame': 'from date of birth until hospital discharge or 1 year whichever comes first', 'description': 'Exclusive maternal breast milk feeding at the time of hospital discharge'}, {'measure': 'Any Direct Breast Feeding at Discharge', 'timeFrame': 'within 24 hours of hospital discharge', 'description': 'Direct breastfeeding within 24 hours of hospital discharge (yes/no)'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'from date of birth until hospital discharge or 1 year whichever comes first', 'description': 'Time from birth until infants being managed for NOWS are discharged from the hospital'}, {'measure': 'Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent)', 'timeFrame': 'from date of birth until hospital discharge or 1 year whichever comes first', 'description': 'composite of the following: seizures, accidental trauma, respiratory insufficiency due to opioid therapy'}, {'measure': 'Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions', 'timeFrame': 'at 3 months of age', 'description': 'Outpatient composite safety outcome which includes acute/urgent care and/or emergency room visits, hospital readmissions at 3 months (present/absent)'}, {'measure': 'Critical Safety Outcome', 'timeFrame': 'at 3 months of age.', 'description': 'any non-accidental trauma and death (yes/no)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NOWS'], 'conditions': ['Neonatal Opiate Withdrawal Syndrome']}, 'referencesModule': {'references': [{'pmid': '41110632', 'type': 'DERIVED', 'citation': 'Beauman SGS, Hu Z, Rice W, Devlin L, Merhar SL, Fung CM, Brown J, Osman A, Pahl A, Ramsey KW, Whalen B, MacMillan KDL, Ounpraseuth ST, Das A, Crawford MM, Trochinski L, Greenberg RG, Smith PB, Young LW, Maxwell JR; Eunice Kennedy Shriver NICHD Neonatal Research Network and the NIH ECHO Program IDeA States Pediatrics Clinical Trials Network. Antenatal Exposure to Medication for Opioid Use Disorder and Infant Outcomes in the Eat, Sleep, Console for Neonatal Opioid Withdrawal Randomized Controlled Trial. J Pediatr. 2025 Oct 17;289:114859. doi: 10.1016/j.jpeds.2025.114859. Online ahead of print.'}, {'pmid': '39133505', 'type': 'DERIVED', 'citation': 'Merhar SL, Hu Z, Devlin LA, Ounpraseuth ST, Simon AE, Smith PB, Walsh MC, Lee JY, Das A, Higgins RD, Crawford MM, Rice W, Paul DA, Maxwell JR, Telang SD, Fung CM, Wright T, Reynolds AM, Hahn D, Ross J, McAllister JM, Crowley M, Shaikh SK, Christ L, Brown J, Riccio J, Wong Ramsey K, Braswell EF, Tucker L, McAlmon K, Dummula K, Weiner J, White JR, Howell MP, Newman S, Snowden JN, Young LW; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network National Institutes of Health Environmental Influences on Child Health Outcomes Program Institutional Development Award States Pediatric Clinical Tri; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network National Institutes of Health Environmental Influences on Child Health Outcomes Program Institutional Development Award States Pediatric Clinical Trials Network. Infant Feeding and Weight Trajectories in the Eat, Sleep, Console Trial: A Secondary Analysis of a Randomized Clinical Trial. JAMA Pediatr. 2024 Oct 1;178(10):976-984. doi: 10.1001/jamapediatrics.2024.2578.'}, {'pmid': '38619854', 'type': 'DERIVED', 'citation': 'Devlin LA, Hu Z, Merhar SL, Ounpraseuth ST, Simon AE, Lee JY, Das A, Crawford MM, Greenberg RG, Smith PB, Higgins RD, Walsh MC, Rice W, Paul DA, Maxwell JR, Fung CM, Wright T, Ross J, McAllister JM, Crowley M, Shaikh SK, Christ L, Brown J, Riccio J, Wong Ramsey K, Braswell EF, Tucker L, McAlmon K, Dummula K, Weiner J, White JR, Newman S, Snowden JN, Young LW; Eunice Kennedy Shriver NICHD Neonatal Research Network and NIH Environmental Influences on Child Health Outcomes (ECHO) Program Institutional Development Award States Pediatric Clinical Trials Network. Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial. JAMA Pediatr. 2024 Jun 1;178(6):525-532. doi: 10.1001/jamapediatrics.2024.0544.'}, {'pmid': '37125831', 'type': 'DERIVED', 'citation': 'Young LW, Ounpraseuth ST, Merhar SL, Hu Z, Simon AE, Bremer AA, Lee JY, Das A, Crawford MM, Greenberg RG, Smith PB, Poindexter BB, Higgins RD, Walsh MC, Rice W, Paul DA, Maxwell JR, Telang S, Fung CM, Wright T, Reynolds AM, Hahn DW, Ross J, McAllister JM, Crowley M, Shaikh SK, Puopolo KM, Christ L, Brown J, Riccio J, Wong Ramsey K, Akshatha, Braswell EF, Tucker L, McAlmon KR, Dummula K, Weiner J, White JR, Howell MP, Newman S, Snowden JN, Devlin LA; ACT NOW Collaborative. Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal. N Engl J Med. 2023 Jun 22;388(25):2326-2337. doi: 10.1056/NEJMoa2214470. Epub 2023 Apr 30.'}]}, 'descriptionModule': {'briefSummary': 'The overall objective is to determine if the ESC care approach will reduce the time until infants being managed for NOWS are medically ready for discharge.', 'detailedDescription': "This study will randomize institutions in blocks to transition from usual institutional care for infants with NOWS to the ESC care approach at a randomly allocated transition period (from usual care to the ESC care approach).\n\nDuring the initial birth hospitalization, the clinical site research team will collect data under waiver of consent for infants who meet eligibility criteria.\n\nThe site research team will obtain informed consent from the legal guardian(s) to obtain long-term outcomes for eligible infants and caregivers. Clinical site research team members may obtain this consent at any point during the hospital stay for infants who meet the trial's inclusion criteria. This data will allow the protocol study team to short- and long-term outcomes for infants managed with the ESC care approach compared to usual institutional care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. The infant is being managed for NOWS at an eligible site (i.e., receiving non-pharmacologic care, assessments for withdrawal severity, +/- pharmacologic care) 2. The infant is ≥ 36 weeks gestation 3. The infant satisfies at least 1 of the following criteria:\n\n 1. Maternal history of prenatal opioid use\n 2. Maternal toxicology screen positive for opioids during the second and/or third trimester of pregnancy\n 3. Infant toxicology screen positive for opioids during the initial hospital stay\n\nExclusion Criteria:\n\n* 1\\. Infant has major birth defect(s) 2. Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed by 60 hours of life 3. Infant was receiving respiratory support (any positive pressure or oxygen therapy) unrelated to pharmacologic treatment for NOWS at 60 hours of life 4. Infant was receiving antimicrobial(s) at 60 hours of life 5. Infant has received any major surgical intervention in the first 60 hours of life 6. Postnatal opioid exposure other than for treatment of NOWS in the first 60 hours of life 7. Outborn infants transferred at \\>60 hours of life or treated with opioids for NOWS at the transferring hospital'}, 'identificationModule': {'nctId': 'NCT04057820', 'acronym': '(ESC-NOW)', 'briefTitle': 'Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach', 'organization': {'class': 'NETWORK', 'fullName': 'Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program'}, 'officialTitle': 'Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach', 'orgStudyIdInfo': {'id': 'ACTNOW-01'}, 'secondaryIdInfos': [{'id': '3U2COD023375-06S1', 'link': 'https://reporter.nih.gov/quickSearch/3U2COD023375-06S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care, Finnegan Neonatal Abstinence Scoring Tool', 'description': 'Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)', 'interventionNames': ['Other: Finnegan Neonatal Abstinence Scoring Tool']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Eat, Sleep, Console care tool', 'description': 'New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool', 'interventionNames': ['Other: Eat, Sleep, Console (ESC) care tool']}], 'interventions': [{'name': 'Finnegan Neonatal Abstinence Scoring Tool', 'type': 'OTHER', 'otherNames': ['FNAST'], 'description': 'The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.', 'armGroupLabels': ['Usual care, Finnegan Neonatal Abstinence Scoring Tool']}, {'name': 'Eat, Sleep, Console (ESC) care tool', 'type': 'OTHER', 'otherNames': ['ESC'], 'description': 'The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.', 'armGroupLabels': ['Eat, Sleep, Console care tool']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Chistiana Care Health Systems', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '96826', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Kapiolani Hospital', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas University Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66204', 'city': 'Shawnee Mission', 'state': 'Kansas', 'country': 'United States', 'facility': 'Shawnee Mission Medical Center', 'geoPoint': {'lat': 39.02, 'lon': -94.66583}}, {'zip': '41017', 'city': 'Edgewood', 'state': 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