- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02810782
How to Treat Opiate Withdrawal in Neonates
Pharmacological Treatment of Narcotic Neonatal Withdrawal
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Neonatal narcotic abstinence syndrome is an important medical, social and financial problem. Several drugs are used to treat the withdrawal symptoms in neonates that have been exposed to opiates in utero, but there is no consensus which one is best.
Goal: Three different drugs are used in a randomised, double blind, clinical multi-centre trial with three arms. Major objective is to investigate the duration of drug treatment based on the Finnegan score. Secondary objectives are to document weight gain, the need for adding a second drug when the first drug is not effective enough and possible side effects such as convulsions.
Methods: Neonates born after 34 completed weeks of gestation with meconium proven antenatal opiate exposure and parental informed consent are included. Infants with severe malformation are excluded. Each infant is assessed every eight hour by a modified Finnegan score. When 9 points are exceeded drug treatment is started and dose increased stepwise according to the score. The masqued solution applied orally contains morphine, phenobarbital or chlorpromazine. When the maximum dose does not reduce the score, a second randomisation and one of the two remaining drugs is added, again in a blinded way.
A total of 120 infants, 40 in each group will be included in the study.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Neonates of mothers who consumed opiates during pregnancy
- Born after 34 completed weeks of pregnancy
- Parents' informed consent
Exclusion Criteria:
- Preterm birth before 34 0/7 gestational weeks
- Severe malformation
- Illness requiring respiratory assistance or catecholamines
- Negative meconium drug test
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phenobarbital
Phenobarbitone loading dose 10 mg/kg body weight maintenance dose 0.83 mg/kg body weight every 4 hours
|
Phenobarbital per os
Other Names:
|
Active Comparator: Chlorpromazine
Chlorpromazine loading dose 0.5 mg/kg body weight maintenance dose 0.25 mg/kg every 4 hours
|
Chlorpromazine per os
Other Names:
|
Active Comparator: Morphine
Morphine (tinctura opii) 0.25 mg/kg body weight every 4 hours
|
Morphine per os
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of treatment
Time Frame: 0 to 42 days
|
Treatment is reduced stepwise until withdrawal symptoms have gone
|
0 to 42 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of convulsions
Time Frame: Whole time of hospitalisation (up to 10 weeks)
|
Whole time of hospitalisation (up to 10 weeks)
|
|
Weight gain
Time Frame: through study completion, up to 10 weeks
|
through study completion, up to 10 weeks
|
|
Treatment failures (need for adding second medication)
Time Frame: through study completion, up to 10 weeks
|
Need for additional drug if investigational drug does not control withdrawal symptoms
|
through study completion, up to 10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hans U Bucher, Prof, University of Zurich
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Infant, Newborn, Diseases
- Neonatal Abstinence Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Antiemetics
- Gastrointestinal Agents
- Analgesics, Opioid
- Narcotics
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Dopamine Agents
- Dopamine Antagonists
- Hypnotics and Sedatives
- GABA Modulators
- GABA Agents
- Anticonvulsants
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Cytochrome P-450 CYP2B6 Inducers
- Morphine
- Chlorpromazine
- Phenobarbital
Other Study ID Numbers
- UZH-NAS01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neonatal Abstinence Syndrome
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Indiana UniversityCompletedNeonatal Abstinence Syndrome | Neonatal Opioid Withdrawal Syndrome | Neonatal Opioid WithdrawalUnited States
-
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