How to Treat Opiate Withdrawal in Neonates
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|ClinicalTrials.gov Identifier: NCT02810782|
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Abstinence Syndrome||Drug: Phenobarbital Drug: Chlorpromazine Drug: Morphine||Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pharmacological Treatment of Narcotic Neonatal Withdrawal|
|Study Start Date :||June 2001|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
Phenobarbitone loading dose 10 mg/kg body weight maintenance dose 0.83 mg/kg body weight every 4 hours
Phenobarbital per os
Other Name: Phenobarbitone
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 Name: Largactil
Active Comparator: Morphine
Morphine (tinctura opii) 0.25 mg/kg body weight every 4 hours
Morphine per os
Other Name: tinctura opii
- Duration of treatment [ Time Frame: 0 to 42 days ]Treatment is reduced stepwise until withdrawal symptoms have gone
- Incidence of convulsions [ Time Frame: Whole time of hospitalisation (up to 10 weeks) ]
- Weight gain [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810782
|Study Chair:||Hans U Bucher, Prof||University of Zurich|