Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-31 @ 4:42 AM
Study NCT ID:
NCT01175668
Status:
TERMINATED
Last Update Posted:
2014-01-06
First Post:
2010-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clonidine for Neonatal Abstinence Syndrome Study
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': 'D003000', 'term': 'Clonidine'}, {'id': 'D010634', 'term': 'Phenobarbital'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001463', 'term': 'Barbiturates'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rachana.singhmd@bhs.org', 'phone': '413-794-2400', 'title': 'Rachana Singh, MD', 'organization': 'Baystate Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'One of the major limitations to our study was the inability to blind the two groups for the study medications.'}}, 'adverseEventsModule': {'timeFrame': 'During the hospital stay', 'description': 'In the phenobarbital group, 3 infants (8.8%), manifested over sedation signs (poor feeds, and mild respiratory depression). This prompted serum phenobarbital measurements which were noted to be supra-therapeutic (\\>40 mg/dL) and required dosage adjustment.', 'eventGroups': [{'id': 'EG000', 'title': 'NMS/Clonidine', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NMS/Phenobarbital', 'otherNumAtRisk': 34, 'otherNumAffected': 3, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Oversedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Length of Treatment With Neonatal Morphine Sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NMS/Clonidine'}, {'id': 'OG001', 'title': 'NMS/Phenobarbital'}], 'classes': [{'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '14.9', 'upperLimit': '21.5'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '16.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'subjects were followed for the duration of treatment, up to 3 months', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Dose of NMS Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NMS/Clonidine'}, {'id': 'OG001', 'title': 'NMS/Phenobarbital'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '6.8'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '5.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For the duration of treatment, upto 3 months', 'unitOfMeasure': 'mg/kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NMS/Clonidine', 'description': 'Dosing was based on the Finnegan scores as below\n\nFinn Score 8-10 NMS 0.32mg/kg/day + Clonidine 6 mcg/kg/day 11-13 NMS 0.48 mg/kg/day + Clonidine 8 mcg/kg/day 14-16 NMS 0.64 mg/kg/day + Clonidine 10 mcg/kg/day ≥17 NMS 0.8 mg/kg/day\\* + Clonidine 12 mcg/kg/day\n\nDaily NMS dose was divided for q3h dosing interval Daily Clonidine dose was divided for q6h dosing interval Clonidine escalation may be limited by hypotension or bradycardia\n\n\\*If needing morphine sulfate \\> 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score \\< 8'}, {'id': 'FG001', 'title': 'NMS/Phenobarbital', 'description': 'Dosing was based on the Finnegan scores as below\n\nFinn Score 8-10 NMS 0.32mg/kg/day +Phenobarbital 6 mg/kg/day 11-13 NMS 0.48 mg/kg/day +Phenobarbital 8 mg/kg/day 14-16 NMS 0.64 mg/kg/day +Phenobarbital 10 mg/kg/day ≥17 NMS 0.8 mg/kg/day\\* + Phenobarbital 12 mg/kg/day\n\nDaily NMS dose was divided for q3h dosing interval Daily Phenobarbital dose was divided for q8h dosing interval\n\n\\*If needing morphine sulfate \\> 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score \\< 8'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "The study was conducted at Baystate Children's Hospital Davis Neonatal Intensive Care Unit (NICU), a level III, regional perinatal referral center, for Western Massachusetts, from June 2010 to June 2012", 'preAssignmentDetails': 'Overall 82 infants were consented for the study but 14 were excluded either because they did not have continued high modified Finnegan Scores (n=13), or had Unstable clinical status (n=1)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NMS/Clonidine'}, {'id': 'BG001', 'title': 'NMS/Phenobarbital'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '2.26', 'spread': '1.60', 'groupId': 'BG001'}, {'value': '2.05', 'spread': '1.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'whyStopped': 'Based on the planned interim analysis results at 50% recruitment, after IRB reviewed the results, further enrollment was stopped.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-18', 'studyFirstSubmitDate': '2010-07-14', 'resultsFirstSubmitDate': '2013-09-03', 'studyFirstSubmitQcDate': '2010-08-04', 'lastUpdatePostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-18', 'studyFirstPostDateStruct': {'date': '2010-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Treatment With Neonatal Morphine Sulfate', 'timeFrame': 'subjects were followed for the duration of treatment, up to 3 months'}], 'secondaryOutcomes': [{'measure': 'Total Dose of NMS Used', 'timeFrame': 'For the duration of treatment, upto 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Neonatal Abstinence Syndrome']}, 'referencesModule': {'references': [{'pmid': '23949834', 'type': 'RESULT', 'citation': 'Surran B, Visintainer P, Chamberlain S, Kopcza K, Shah B, Singh R. Efficacy of clonidine versus phenobarbital in reducing neonatal morphine sulfate therapy days for neonatal abstinence syndrome. A prospective randomized clinical trial. J Perinatol. 2013 Dec;33(12):954-9. doi: 10.1038/jp.2013.95. Epub 2013 Aug 15.'}]}, 'descriptionModule': {'briefSummary': "The study plans to compare the use of Clonidine versus Phenobarbital as an additional medication to neonatal morphine sulfate for treatment of newborn infants undergoing drug withdrawal symptoms due to mother's use of opioid drug use. The investigators hypothesis is that use of Clonidine will lead to shorter duration of treatment, hospital stay and thereby early discharge home.", 'detailedDescription': "Introduction: Neonatal abstinence syndrome (NAS) is a symptom complex experienced by 55 to 94% of neonates who are exposed to intrauterine opioids. Recent studies have shown that combination therapies are superior to monotherapy with neonatal morphine sulfate (NMS). Phenobarbital has been shown to reduce the length of hospitalization, decrease severity of withdrawal, as well as decrease hospital costs and care giver demands. Similarly, clonidine, an α2-adrenergic receptor agonist, has also been shown to be safe, effective and reduces length of treatment.\n\nPhenobarbital as an antiepileptic acts on the GABA (A) receptors and has been shown in animal models to inhibit neuronal cell proliferation, survival and neurogenesis. In human infants long term treatment with phenobarbital may result in neuro-developmental compromise. Due to these potentially harmful effects of Phenobarbital (P) alternative therapies should be explored more thoroughly including clonidine (C).\n\nOur primary aim is to compare the length of NAS treatment with NMS in the two study groups - NMS/C versus NMS/P. Our secondary aims are to compare the total dosage of NMS, total length of hospital stay for NAS treatment, treatment failures and adverse effect profiles for the two study groups. We hypothesize that clonidine when compared to phenobarbital as an adjunct therapy, will have shorter length of stay, with fewer treatment failures and side effects.\n\nStudy design/Methods: This study will be a prospective, randomized, non-blinded clinical trial of NMS/C versus NMS/P for treatment of infants with NAS. Infants will be recruited from the Baystate Children's Hospital Neonatal Intensive Care Unit (NICU) and Neonatal Continuing Care Nursery (NCCN), a level III unit, over a 2 year study period. After randomization, infants will adhere to strict treatment initiation and withdrawal protocols. Maternal and infant descriptive data will be collected along with specific data regarding vital signs, drug dosages, length of treatment, treatment failures and adverse effects.\n\nThe primary outcome will be length of treatment with NMS in the two study arms. The secondary outcomes will be - a) total length of hospital stay for NAS treatment, b) mean total treatment dose and mean daily dose of NMS, c) total number of treatment failures,d) adverse effects such as bradycardia, hypotension, hypertension e) Total outpatient therapy days with Phenobarbital\n\nSignificance: This comparison study is potentially of great significance. If clonidine is proven to be equally effective in treatment of NAS many of the detrimental effects of phenobarbital therapy may be avoided for infants on long term pharmacotherapy for treatment of withdrawal with shorter length of hospital stay."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 0 to 15 days of age\n* Prenatal exposure to opioids with development of moderate to severe NAS (2 consecutive abstinence scores of ≥ 8)\n* Medically stable\n\nExclusion Criteria:\n\n* Gestational age \\< 35 weeks\n* Intrauterine growth retardation (birth weight below the 5th percentile)\n* Congenital heart disease\n* Congenital anomalies\n* Medically unstable\n\nExposure to Benzodiazepines prenatally\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01175668', 'briefTitle': 'Clonidine for Neonatal Abstinence Syndrome Study', 'organization': {'class': 'OTHER', 'fullName': 'Baystate Medical Center'}, 'officialTitle': 'Comparison of Clonidine Versus Phenobarbital as an Adjunct Therapy for Neonatal Abstinence Syndrome', 'orgStudyIdInfo': {'id': 'BH-10-196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NMS/Clonidine', 'interventionNames': ['Drug: Clonidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NMS/Phenobarbital', 'interventionNames': ['Drug: Phenobarbital']}], 'interventions': [{'name': 'Clonidine', 'type': 'DRUG', 'description': 'This group of infants undergoing NAS will be treated with neonatal morphine sulfate and Clonidine as an adjunct medication to control the symptoms. Once stable Finnegan scores \\<8 for 24h, NMS will be weaned by 10% daily till off, then Clonidine will be weaned off in a stepwise manner. Infant will not go home on any medication for NAS. NMS will be dosed as mg/kd/day divided q3h and Clonidine will be dosed as microgm/kg/day divided q6h based upon the initial Finnegan scores.', 'armGroupLabels': ['NMS/Clonidine']}, {'name': 'Phenobarbital', 'type': 'DRUG', 'description': 'Infants in this arm will be treated as current standard practice with NMS and Phenobarbital. NMS will be weaned by 10% daily to completely off during the hospital stay. Infants will be discharged home on Phenobarbital.\n\nNMS will be dosed as mg/kg/day divided q3h and Phenobarbital will be dosed as mg/kg/day divided q8h based on the Finnegan scores.', 'armGroupLabels': ['NMS/Phenobarbital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': "NICU @ Baystate Children's Hospital", 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}], 'overallOfficials': [{'name': 'Rachana Singh, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baystate Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baystate Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Rachana Singh, MD', 'investigatorAffiliation': 'Baystate Medical Center'}}}}