Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-30 @ 6:39 PM
Study NCT ID:
NCT01734551
Status:
COMPLETED
Last Update Posted:
2017-09-12
First Post:
2012-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
NAS Treatment - Opiate Versus Non-Opiate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D009020', 'term': 'Morphine'}, {'id': 'D003000', 'term': 'Clonidine'}], 'ancestors': [{'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'}, {'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hbada2@uky.edu', 'phone': '859-323-1019', 'title': 'Dr. Henrietta S. Bada, Professor and Vice Chair, Academic Affairs', 'organization': 'University of Kentucky'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Daily review of inpatient care and activity. Upon discharge, electronic medical records reviewed for 3 months after infant left UK NICU. Assessments at NICU Graduate Clinic were done at 3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Morphine', 'description': 'Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.\n\nMorphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.\n\nOnce stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is \\<0.1mg/kg/day, may discontinue.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Clonidine', 'description': 'Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.\n\nClonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Finnegan Neonatal Abstinence Scoring System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine', 'description': 'Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.\n\nMorphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.\n\nOnce stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is \\<0.1mg/kg/day, may discontinue.'}, {'id': 'OG001', 'title': 'Clonidine', 'description': 'Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.\n\nClonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.'}], 'classes': [{'title': 'Finnegan scores day 2 of treatment', 'categories': [{'measurements': [{'value': '7.5', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Finnegan scores day 7 of treatment', 'categories': [{'measurements': [{'value': '6.6', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Finnegan scores day 14 of treatment', 'categories': [{'measurements': [{'value': '7.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '0.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'Mean of total Finnegan Scores obtained every 3 hours on days 2, 7, and 14 following start of treatment; A score is a number representing the total score or sum from 21 items or symptoms or manifestations of opiate withdrawal in newborn infants. The total score ranges from 0 to 43. Reference: 1. Finnegan LP, Connaughton JF, Jr., Kron RE, et al. Neonatal abstinence syndrome: assessment and management. Addict Dis 1975;2(1-2):141-58. Although normal newborn may manifest mild symptoms that will give scores in the range of 0 to 7. A score of 8 consecutively obtained times 3 indicate that infant will benefit from treatment, in this study morphine or clonidine. A decrease in scores especially to less than 8 is suggestive of a good response to treatment.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Duration of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine', 'description': 'Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.\n\nMorphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.\n\nOnce stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is \\<0.1mg/kg/day, may discontinue.'}, {'id': 'OG001', 'title': 'Clonidine', 'description': 'Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.\n\nClonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '89'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '107'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '120 days', 'description': 'Total number days of treatment', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine', 'description': 'Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.\n\nMorphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.\n\nOnce stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is \\<0.1mg/kg/day, may discontinue.'}, {'id': 'OG001', 'title': 'Clonidine', 'description': 'Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.\n\nClonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.'}], 'classes': [{'title': 'Attention', 'categories': [{'measurements': [{'value': '5.06', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '4.51', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Handling', 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Quality of movement', 'categories': [{'measurements': [{'value': '4.77', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '4.92', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Regulation', 'categories': [{'measurements': [{'value': '5.2', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '5.26', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Non-optimal reflexes', 'categories': [{'measurements': [{'value': '3.73', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '4.13', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Asymmetric reflexes', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Stress/abstinence', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'Arousal', 'categories': [{'measurements': [{'value': '3.91', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '3.95', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Hypertonicity', 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Hypotonicity', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Excitability', 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '2.38', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': 'Lethargy', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '5.13', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5-10 days after treatment starts', 'description': 'The summary scores from the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) give a measure of infant neurobehavior in the following areas (score range): habituation (1-9), regulation (2.20-7.50), attention (1.29 -8.4), Handling (0 - 1), quality of movement (1.20 - 6.20), Non-optimal reflexes (0-12), Asymmetric reflexes (0-7), arousal (2.43 - 6.67), hypertonicity (0- 8), hypotonicity (0 - 5.0), excitability (0-11), lethargy (0 - 11.0). and stress/abstinence (0. - 0.57). A higher score for each item means a higher level of the construct. For example, a higher score for hypertonicity means the infant is more hypertonic and higher score on hypotonicity means the infant is more hypotonic. No cut-off score published for normal or abnormal behavioral performance. Reference: Lester BM et al. Summary Statistics of Neonatal Intensive Care Unit Network Neurobehavioral Scale Scores From the Maternal Lifestyle Study: A Quasinormative Sample, in Pediatrics 2004; 113,668.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bayley Scales of Infant and Toddler Development Third Edition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine', 'description': 'Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.\n\nMorphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.\n\nOnce stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is \\<0.1mg/kg/day, may discontinue.'}, {'id': 'OG001', 'title': 'Clonidine', 'description': 'Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.\n\nClonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.'}], 'classes': [{'title': 'Bayley III motor', 'categories': [{'measurements': [{'value': '97.6', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '95.8', 'spread': '7.2', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive', 'categories': [{'measurements': [{'value': '92.9', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '93.3', 'spread': '7.2', 'groupId': 'OG001'}]}]}, {'title': 'Language total', 'categories': [{'measurements': [{'value': '98.0', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '95.8', 'spread': '10.4', 'groupId': 'OG001'}]}]}, {'title': 'Language Receptive', 'categories': [{'measurements': [{'value': '101.1', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '95.0', 'spread': '12.2', 'groupId': 'OG001'}]}]}, {'title': 'Language Expressive', 'categories': [{'measurements': [{'value': '100.0', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '99.2', 'spread': '13.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year of life', 'description': 'Scores obtained Bayley Scales of Infant and Toddler Development Third Edition in the developmental domains of motor, cognitive, and language. This tool for measures of motor, cognitive and language development is a series of standardized measurements and for each domain, the standardized scores have a mean of 100 and standard deviation of 15. Scores below 1 standard deviation (= or less than 84) is considered below normal. Scores above 1 standard deviation (over 115) represent higher than normal functioning in each domain The score for each domain (motor, cognitive, and language functioning) represents the full-scale score', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The above number fo reach arm represents the number of subjects who came for follow-up evaluation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Morphine', 'description': 'Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.\n\nMorphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.\n\nOnce stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is \\<0.1mg/kg/day, may discontinue.'}, {'id': 'FG001', 'title': 'Clonidine', 'description': 'Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.\n\nClonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Morphine', 'description': 'Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.\n\nMorphine: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.\n\nOnce stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is \\<0.1mg/kg/day, may discontinue.'}, {'id': 'BG001', 'title': 'Clonidine', 'description': 'Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.\n\nClonidine: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-11', 'studyFirstSubmitDate': '2012-11-21', 'resultsFirstSubmitDate': '2016-09-23', 'studyFirstSubmitQcDate': '2012-11-21', 'lastUpdatePostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-11', 'studyFirstPostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Finnegan Neonatal Abstinence Scoring System', 'timeFrame': '14 days', 'description': 'Mean of total Finnegan Scores obtained every 3 hours on days 2, 7, and 14 following start of treatment; A score is a number representing the total score or sum from 21 items or symptoms or manifestations of opiate withdrawal in newborn infants. The total score ranges from 0 to 43. Reference: 1. Finnegan LP, Connaughton JF, Jr., Kron RE, et al. Neonatal abstinence syndrome: assessment and management. Addict Dis 1975;2(1-2):141-58. Although normal newborn may manifest mild symptoms that will give scores in the range of 0 to 7. A score of 8 consecutively obtained times 3 indicate that infant will benefit from treatment, in this study morphine or clonidine. A decrease in scores especially to less than 8 is suggestive of a good response to treatment.'}, {'measure': 'Duration of Treatment', 'timeFrame': '120 days', 'description': 'Total number days of treatment'}], 'secondaryOutcomes': [{'measure': 'Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)', 'timeFrame': '5-10 days after treatment starts', 'description': 'The summary scores from the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) give a measure of infant neurobehavior in the following areas (score range): habituation (1-9), regulation (2.20-7.50), attention (1.29 -8.4), Handling (0 - 1), quality of movement (1.20 - 6.20), Non-optimal reflexes (0-12), Asymmetric reflexes (0-7), arousal (2.43 - 6.67), hypertonicity (0- 8), hypotonicity (0 - 5.0), excitability (0-11), lethargy (0 - 11.0). and stress/abstinence (0. - 0.57). A higher score for each item means a higher level of the construct. For example, a higher score for hypertonicity means the infant is more hypertonic and higher score on hypotonicity means the infant is more hypotonic. No cut-off score published for normal or abnormal behavioral performance. Reference: Lester BM et al. Summary Statistics of Neonatal Intensive Care Unit Network Neurobehavioral Scale Scores From the Maternal Lifestyle Study: A Quasinormative Sample, in Pediatrics 2004; 113,668.'}, {'measure': 'Bayley Scales of Infant and Toddler Development Third Edition', 'timeFrame': '1 year of life', 'description': 'Scores obtained Bayley Scales of Infant and Toddler Development Third Edition in the developmental domains of motor, cognitive, and language. This tool for measures of motor, cognitive and language development is a series of standardized measurements and for each domain, the standardized scores have a mean of 100 and standard deviation of 15. Scores below 1 standard deviation (= or less than 84) is considered below normal. Scores above 1 standard deviation (over 115) represent higher than normal functioning in each domain The score for each domain (motor, cognitive, and language functioning) represents the full-scale score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prenatal opiate exposure', 'neonatal withdrawal', 'Pharmacologic treatment'], 'conditions': ['Neonatal Abstinence Syndrome']}, 'referencesModule': {'references': [{'pmid': '34231914', 'type': 'DERIVED', 'citation': 'Zankl A, Martin J, Davey JG, Osborn DA. Opioid treatment for opioid withdrawal in newborn infants. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD002059. doi: 10.1002/14651858.CD002059.pub4.'}, {'pmid': '25624389', 'type': 'DERIVED', 'citation': 'Bada HS, Sithisarn T, Gibson J, Garlitz K, Caldwell R, Capilouto G, Li Y, Leggas M, Breheny P. Morphine versus clonidine for neonatal abstinence syndrome. Pediatrics. 2015 Feb;135(2):e383-91. doi: 10.1542/peds.2014-2377.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two different medicines to treat babies with opiate withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine is another drug, but is different from morphine. It is also used for babies, and even adults for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if one may be better than the other.', 'detailedDescription': 'Withdrawal from drugs, called Neonatal abstinence syndrome (NAS), is a group of symptoms that occurs to babies whose mother took or used drugs (prescription, addicting, illegal, pain pills, or drugs for addiction treatment) during pregnancy. Medicines the mother takes while pregnant, the baby also takes. Babies may experience withdrawal after delivery, and may need treatment. There are different ways to treat babies with withdrawal - about 50% of doctors use morphine, an opiate, to treat these babies, the rest uses other drugs, like clonidine and phenobarbitol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to Neonatal Intensive Care Unit (NICU)- Gestational age (GA) \\>or= 35 wks\n* Known prenatal opiate exposure (maternal history, positive opiate screen, positive neonatal urine or meconium screen)\n* Symptomatic with Finnegan Neonatal Abstinence Scores meeting NICU protocol for treatment\n\nExclusion Criteria:\n\n* Seizures\n* Major congenital malformations\n* Unlikely to survive\n* Parents not able to understand English'}, 'identificationModule': {'nctId': 'NCT01734551', 'acronym': 'NAS', 'briefTitle': 'NAS Treatment - Opiate Versus Non-Opiate', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Pharmacological Treatment of Neonatal Abstinence Syndrome: Opiate Versus Non-Opiate', 'orgStudyIdInfo': {'id': '11-0534'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine', 'description': 'Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.', 'interventionNames': ['Drug: Morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clonidine', 'description': 'Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.', 'interventionNames': ['Drug: Clonidine']}], 'interventions': [{'name': 'Morphine', 'type': 'DRUG', 'otherNames': ['Morphine sulfate'], 'description': 'Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.\n\nOnce stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is \\<0.1mg/kg/day, may discontinue.', 'armGroupLabels': ['Morphine']}, {'name': 'Clonidine', 'type': 'DRUG', 'otherNames': ['clonidine hydrochloride'], 'description': 'Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.', 'armGroupLabels': ['Clonidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Medical Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Henrietta S Bada, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henrietta Bada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Henrietta Bada', 'investigatorAffiliation': 'University of Kentucky'}}}}