Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-01-05 @ 5:40 PM
Study NCT ID:
NCT03134703
Status:
TERMINATED
Last Update Posted:
2023-07-03
First Post:
2017-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009357', 'term': 'Neonatal Abstinence Syndrome'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008691', 'term': 'Methadone'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sbrook36@jhmi.edu', 'phone': '727-767-4313', 'title': 'Sandra Brooks, MD', 'organization': "Johns Hopkins All Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected throughout study participation until 12 months of age in the methadone arm. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed for the Comparison Group.', 'description': 'AEs as defined in the clinicaltrials.gov site and must meet at least one of the following:\n\nPossibly related to study drug, unexpected in nature or severity OR One of the following:\n\nRespiratory depressions, bronchospasm, angioneurotic edema, anaphylactic shock, need for respiratory support, cardiovascular compromise\n\nAll-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed for the Comparison Group.', 'eventGroups': [{'id': 'EG000', 'title': 'Methadone Treatment Group', 'description': 'NAS infants treated for withdrawal symptoms with methadone\n\nMethadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Comparison Group', 'description': "NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)\n\nMorphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Length of Stay (LOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone Treatment Group', 'description': 'NAS infants treated for withdrawal symptoms with methadone\n\nMethadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': "NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)\n\nMorphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '15'}, {'value': '16.2', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '25'}]}]}], 'paramType': 'MEAN', 'timeFrame': '25 days', 'description': 'Compare the LOS of Neonatal Intensive Care Unit (NICU) infants with Neonatal Abstinence Syndrome (NAS) treated with methadone with historical data and a comparison group of NICU NAS infants treated with a different narcotic agent.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Study closed prematurely due to poor accrual. There were 3 screen fails (did not receive study drug) in the methadone treatment group, therefore LOS was not calculated for those participants.'}, {'type': 'SECONDARY', 'title': 'Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone Treatment Group', 'description': 'NAS infants treated for withdrawal symptoms with methadone\n\nMethadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': "NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)\n\nMorphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"}], 'classes': [{'title': 'Factor 1 inpatient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Factor 2 inpatient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Factor 3 inpatient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Factor 4 inpatient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Factor 1 6-8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Factor 2 6-8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Factor 3 6-8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': 'Factor 4 6-8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'inpatient and at 6-8 weeks of age', 'description': "The Postpartum Bonding Questionnaire (PBQ) is a self-rating questionnaire designed to detect disorders of the mother-infant relationship. The questionnaire has 25 statements, each with six alternative responses ranging from 0 (always) to 5 (never). For the PBQ, scores are summated for each factor, with a high score indicating concern for bonding. The PBQ yields a total score between 0 to 125. Positive responses are scored from 0 ('always') to 5 ('never'). Negative responses, are scored from 5 ('always') to 0 ('never').\n\nFactor 1 (impaired bonding) is based on 12 questions, with a score range 0-60 (0-11=normal; 12 \\& above=high).\n\nFactor 2 (rejection \\& anger) is based on 7 questions with a score range 0-35 (0-16=normal; 17 \\& above=high).\n\nFactor 3 (anxiety about care) is based on 4 questions with a score range 0-20 (0-9=normal; 10 \\& above =high).\n\nFactor 4 (risk of abuse) is based on 2 questions, with a score range 0-10 (0-2=normal; 3 \\& above =high).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data analysis was not completed. Results shown below are means for each group, note that many participants replied on the extremes of the answer range (e.g. always or never), which yields very low total scores for each factor.'}, {'type': 'SECONDARY', 'title': 'Maternal Depression Measured With The Edinburgh Postnatal Depression Scale (EPDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone Treatment Group', 'description': 'NAS infants treated for withdrawal symptoms with methadone\n\nMethadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': "NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)\n\nMorphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"}], 'classes': [{'title': 'EPDS inpatient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '20'}]}]}, {'title': 'EPDS 6-8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '10'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '14'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'While inpatient and at 6-8 weeks of age', 'description': 'The Edinburgh Postnatal Depression Scale (EPDS) was developed for screening postpartum women in outpatient, home visiting settings, or at the 6-8 week postpartum examination. The EPDS is a 10-item questionnaire with responses scored 0, 1, 2, or 3 according to increased severity of the symptom. The maximum total score is 30 while the minimum score is 0. A score of 10 or greater, as well as any answer choice other than "never" on question #10 (suicidal thoughts) of the EPDS are indicative of depressive symptomatology.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data analysis was not completed. Results shown below are average scores on the EPDS scale for each group. 9 participants completed the EPDS while in patient, and 4 participants completed the questionnaire at the 6-8 weeks time point.'}, {'type': 'SECONDARY', 'title': 'Readmission to Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone Treatment Group', 'description': 'NAS infants treated for withdrawal symptoms with methadone\n\nMethadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': "NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)\n\nMorphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days of discharge', 'description': 'Number of hospital readmissions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Readmissions to the hospital within 30 days for NAS-related reasons.'}, {'type': 'SECONDARY', 'title': 'Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone Treatment Group', 'description': 'NAS infants treated for withdrawal symptoms with methadone\n\nMethadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': "NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)\n\nMorphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"}], 'timeFrame': '30 days of age', 'description': 'Compare the incidence of providing breast milk (\\> 50% of nutritional needs) at 30 days of age between methadone treated and non-treated infants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study closed prematurely due to poor accrual and no analysis was completed. Incidence of providing breast milk at 30 days was not collected.'}, {'type': 'SECONDARY', 'title': 'Infant Development', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone Treatment Group', 'description': 'NAS infants treated for withdrawal symptoms with methadone\n\nMethadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': "NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)\n\nMorphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"}], 'classes': [{'title': 'Communication at 4m', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.7', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '60'}]}]}, {'title': 'Gross motor at 4m', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '60'}]}]}, {'title': 'Fine motor at 4m', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '60'}]}]}, {'title': 'Problem solving at 4m', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '60'}]}]}, {'title': 'Personal-social at 4m', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '60'}]}]}, {'title': 'Communication at 8m', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '60'}]}]}, {'title': 'Gross motor at 8m', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '50'}]}]}, {'title': 'Fine motor at 8m', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '50'}]}]}, {'title': 'Problem solving at 8m', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '55'}]}]}, {'title': 'Personal-social at 8m', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '50'}]}]}, {'title': 'Communication at 12m', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '50'}]}]}, {'title': 'Gross motor at 12m', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '40'}]}]}, {'title': 'Fine motor at 12m', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '60'}]}]}, {'title': 'Problem solving at 12m', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '50'}]}]}, {'title': 'Personal-social at 12m', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '40'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4, 8 and 12 months of age', 'description': "Assess the age appropriate infant development at 4, 8 and 12 months of age among the methadone treatment group using the Ages and Stages-based questionnaires (ASQ). The questionnaires are screening tools designed to identify infants at risk for developmental delays through caregivers' provision of quantitative information regarding their infant's development. In the ASQ, higher scores indicate more positive outcomes. The ASQ covers 5 areas of development: communication, gross motor, fine motor, problem solving, and personal-social. Scores for each area should fall between 0-60.\n\nScoring:\n\n0-30 = further assessment with a professional may be needed 30-40 = learning activities \\& monitoring are indicated 45-60 = child development appears to be on schedule", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Infant development assessed only on those participants who received study drug (methadone arm). 3 participants completed the ASQ at 4 months, 1 participant at 8 months, and 1 participant at 12 months.'}, {'type': 'SECONDARY', 'title': 'Screened vs. Eligible', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone Treatment Group', 'description': 'NAS infants treated for withdrawal symptoms with methadone\n\nMethadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': "NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)\n\nMorphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"}], 'timeFrame': 'After accrual of the first 50% of participants & after accrual of the second 50% of participants, and at completion of the trial.', 'description': 'Determine the response percentage of mothers who are screened as eligible by PAR officials and who agree to participate in the demonstration project', 'calculatePct': False, 'reportingStatus': 'POSTED', 'populationDescription': 'Study closed prematurely due to poor accrual and no analysis was completed. Response percentage was not collected.'}, {'type': 'SECONDARY', 'title': 'Attrition Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone Treatment Group', 'description': 'NAS infants treated for withdrawal symptoms with methadone\n\nMethadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': "NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)\n\nMorphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"}], 'timeFrame': 'After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.', 'description': 'Assess the drop out percentage of mothers who agree to participate but do not follow through with home discharge for continued care', 'calculatePct': False, 'reportingStatus': 'POSTED', 'populationDescription': 'Study closed prematurely due to poor accrual and no analysis was completed. Drop out percentage was not collected.'}, {'type': 'SECONDARY', 'title': 'Home Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone Treatment Group', 'description': 'NAS infants treated for withdrawal symptoms with methadone\n\nMethadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': "NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)\n\nMorphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"}], 'timeFrame': 'After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial', 'description': 'Quantitate the proportion of mothers who feel comfortable with home care of their infant at discharge', 'reportingStatus': 'POSTED', 'populationDescription': 'Study closed prematurely due to poor accrual and no analysis was completed. Proportion of mothers data was not collected.'}, {'type': 'SECONDARY', 'title': 'Readiness of Mothers to Assess Infant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone Treatment Group', 'description': 'NAS infants treated for withdrawal symptoms with methadone\n\nMethadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': "NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)\n\nMorphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"}], 'timeFrame': 'After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.', 'description': 'Monitor the readiness of mothers to assess infant on 3 to 4 hours intervals while at home', 'reportingStatus': 'POSTED', 'populationDescription': 'Study closed prematurely due to poor accrual and no analysis was completed. Readiness of mothers was not assessed/collected.'}, {'type': 'SECONDARY', 'title': 'Compliance With Pediatrician Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone Treatment Group', 'description': 'NAS infants treated for withdrawal symptoms with methadone\n\nMethadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)'}, {'id': 'OG001', 'title': 'Comparison Group', 'description': "NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)\n\nMorphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"}], 'timeFrame': 'After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.', 'description': "Determine the compliance rate with the Johns Hopkins All Children's Hospital (JHACH) pediatrician visits.", 'reportingStatus': 'POSTED', 'populationDescription': 'Study closed prematurely due to poor accrual and no analysis was completed. Compliance rate was not assessed/collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Methadone Treatment Group', 'description': 'NAS infants treated for withdrawal symptoms with methadone\n\nMethadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)'}, {'id': 'FG001', 'title': 'Comparison Group', 'description': "NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)\n\nMorphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Methadone Treatment Group', 'description': 'NAS infants treated for withdrawal symptoms with methadone\n\nMethadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)'}, {'id': 'BG001', 'title': 'Comparison Group', 'description': "NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)\n\nMorphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '10.4', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '20'}, {'value': '5.5', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '20'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-02', 'size': 1315073, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-02T17:10', 'hasProtocol': True}, {'date': '2016-11-09', 'size': 1336453, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-01-03T09:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Poor recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-28', 'studyFirstSubmitDate': '2017-03-03', 'resultsFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-05', 'studyFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Stay (LOS)', 'timeFrame': '25 days', 'description': 'Compare the LOS of Neonatal Intensive Care Unit (NICU) infants with Neonatal Abstinence Syndrome (NAS) treated with methadone with historical data and a comparison group of NICU NAS infants treated with a different narcotic agent.'}], 'secondaryOutcomes': [{'measure': 'Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ)', 'timeFrame': 'inpatient and at 6-8 weeks of age', 'description': "The Postpartum Bonding Questionnaire (PBQ) is a self-rating questionnaire designed to detect disorders of the mother-infant relationship. The questionnaire has 25 statements, each with six alternative responses ranging from 0 (always) to 5 (never). For the PBQ, scores are summated for each factor, with a high score indicating concern for bonding. The PBQ yields a total score between 0 to 125. Positive responses are scored from 0 ('always') to 5 ('never'). Negative responses, are scored from 5 ('always') to 0 ('never').\n\nFactor 1 (impaired bonding) is based on 12 questions, with a score range 0-60 (0-11=normal; 12 \\& above=high).\n\nFactor 2 (rejection \\& anger) is based on 7 questions with a score range 0-35 (0-16=normal; 17 \\& above=high).\n\nFactor 3 (anxiety about care) is based on 4 questions with a score range 0-20 (0-9=normal; 10 \\& above =high).\n\nFactor 4 (risk of abuse) is based on 2 questions, with a score range 0-10 (0-2=normal; 3 \\& above =high)."}, {'measure': 'Maternal Depression Measured With The Edinburgh Postnatal Depression Scale (EPDS)', 'timeFrame': 'While inpatient and at 6-8 weeks of age', 'description': 'The Edinburgh Postnatal Depression Scale (EPDS) was developed for screening postpartum women in outpatient, home visiting settings, or at the 6-8 week postpartum examination. The EPDS is a 10-item questionnaire with responses scored 0, 1, 2, or 3 according to increased severity of the symptom. The maximum total score is 30 while the minimum score is 0. A score of 10 or greater, as well as any answer choice other than "never" on question #10 (suicidal thoughts) of the EPDS are indicative of depressive symptomatology.'}, {'measure': 'Readmission to Hospital', 'timeFrame': 'Within 30 days of discharge', 'description': 'Number of hospital readmissions'}, {'measure': 'Breast Milk', 'timeFrame': '30 days of age', 'description': 'Compare the incidence of providing breast milk (\\> 50% of nutritional needs) at 30 days of age between methadone treated and non-treated infants'}, {'measure': 'Infant Development', 'timeFrame': '4, 8 and 12 months of age', 'description': "Assess the age appropriate infant development at 4, 8 and 12 months of age among the methadone treatment group using the Ages and Stages-based questionnaires (ASQ). The questionnaires are screening tools designed to identify infants at risk for developmental delays through caregivers' provision of quantitative information regarding their infant's development. In the ASQ, higher scores indicate more positive outcomes. The ASQ covers 5 areas of development: communication, gross motor, fine motor, problem solving, and personal-social. Scores for each area should fall between 0-60.\n\nScoring:\n\n0-30 = further assessment with a professional may be needed 30-40 = learning activities \\& monitoring are indicated 45-60 = child development appears to be on schedule"}, {'measure': 'Screened vs. Eligible', 'timeFrame': 'After accrual of the first 50% of participants & after accrual of the second 50% of participants, and at completion of the trial.', 'description': 'Determine the response percentage of mothers who are screened as eligible by PAR officials and who agree to participate in the demonstration project'}, {'measure': 'Attrition Rate', 'timeFrame': 'After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.', 'description': 'Assess the drop out percentage of mothers who agree to participate but do not follow through with home discharge for continued care'}, {'measure': 'Home Care', 'timeFrame': 'After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial', 'description': 'Quantitate the proportion of mothers who feel comfortable with home care of their infant at discharge'}, {'measure': 'Readiness of Mothers to Assess Infant', 'timeFrame': 'After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.', 'description': 'Monitor the readiness of mothers to assess infant on 3 to 4 hours intervals while at home'}, {'measure': 'Compliance With Pediatrician Visits', 'timeFrame': 'After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.', 'description': "Determine the compliance rate with the Johns Hopkins All Children's Hospital (JHACH) pediatrician visits."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal Abstinence Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a non-randomized, un-blinded feasibility study project comparing the Length of Stay (LOS) of Neonatal Intensive Care Unit (NICU) infants diagnosed with Neonatal Abstinence Syndrome (NAS) treated with methadone with historical data and a comparison group of NICU NAS infants treated with a different narcotic agent.', 'detailedDescription': "For the time frame July 1, 2013 through September 30, 2014, 300 infants with NAS have been cared for in the JHACH NICU with an average length of stay of 30 days. Such a prolonged length of stay has a negative impact on maternal/infant bonding. In addition, infants suffering from NAS have poor regulatory mechanisms and are invariably hard to care for and difficult to console, and they provide an emotional challenge to their caretakers. This challenge becomes even more significant when the caretaker is the mother who is suffering from addiction and is already emotionally compromised by feelings of depression, anxiety, guilt or insecurity. Attachment is an ongoing process and the quality of the relationship between mother and her infant directly influences the structure of the child's affective ties and overall organization of responses to environment. This mother-infant bond sets the stage for understanding and identifying the infant's needs and reciprocal parental response to those needs. Maternal emotional unavailability has potentially serious effects on the long term mother-child relationship, and on the child's development.\n\nThis project provides a novel approach and an alternative care plan for infants with NAS. It is funded by the State of Florida and allows to: 1) educate and empower a specified population of mothers who are undergoing institutionalized rehabilitation and whose infant needs treatment for NAS; 2) safely transition the infants home for final wean of their pharmacologic treatment; 3) provide regular developmental follow up for these infants through our NICU follow up clinic, hence identifying and quickly responding to neuro-developmental delays."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '72 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': "Methadone Treatment Group:\n\nInclusion criteria:\n\n1. Baby is diagnosed with neonatal abstinence syndrome;\n2. Mother under the care of Operation PAR;\n3. Mother resides in Pinellas or Pasco county at the time of enrollment and is expected to throughout the infant's methadone treatment period;\n4. Mother has been deemed by PAR officials as being compliant with the detoxification program;\n5. Mother has completed induction methadone treatment and has had no changes in medication dosage of 10% or greater in the two weeks preceding delivery;\n6. Mother has been prescreened and deemed adequate candidate by the demonstration project team members;\n7. No known concerns from Florida Department of Children and Families regarding the infant's ability to return to the home;\n8. Newborns ≥ 37 0/7 weeks gestation;\n9. Newborns transferred to JHACH within 72 hours from birth;\n10. Newborns ≥ 2.5 kg weight at birth;\n11. Informed parental consent.\n\nExclusion Criteria:\n\n1. Major congenital anomalies;\n2. Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;\n3. Infants who are being placed for adoption;\n4. Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);\n5. Infants whose maternal UDS at the time of delivery is positive for any other drug of abuse beside opiates.\n6. Mother with hearing or language impairment\n\nComparison Group:\n\nInclusion Criteria:\n\n1. Baby is diagnosed with neonatal abstinence syndrome;\n2. Newborns ≥ 37 0/7 weeks gestation;\n3. Newborns transferred to JHACH within 72 hours from birth;\n4. Newborns ≥ 2.5 kg weight at birth;\n5. Informed parental consent.\n\nExclusion Criteria:\n\n1. Infant not requiring pharmacologic treatment for NAS;\n2. Major congenital anomalies;\n3. Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;\n4. Infants who are being placed for adoption;\n5. Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);\n6. Mother with hearing or language impairment;\n7. Infants known upon admission who will be placed into state custody or sheltered."}, 'identificationModule': {'nctId': 'NCT03134703', 'briefTitle': 'Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome', 'organization': {'class': 'OTHER', 'fullName': "Johns Hopkins All Children's Hospital"}, 'officialTitle': 'Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome', 'orgStudyIdInfo': {'id': 'IRB00107690'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methadone Treatment Group', 'description': 'NAS infants treated for withdrawal symptoms with methadone', 'interventionNames': ['Drug: Methadone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparison Group', 'description': "NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)", 'interventionNames': ['Drug: Morphine']}], 'interventions': [{'name': 'Methadone', 'type': 'DRUG', 'description': 'Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)', 'armGroupLabels': ['Methadone Treatment Group']}, {'name': 'Morphine', 'type': 'DRUG', 'description': 'Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)', 'armGroupLabels': ['Comparison Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': "Johns Hopkins All Children's Hospital", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}], 'overallOfficials': [{'name': 'Sandra Brooks, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Johns Hopkins All Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Johns Hopkins All Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Florida Department of Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}