NCT02810782

How to Treat Opiate Withdrawal in Neonates

Pharmacological Treatment of Narcotic Neonatal Withdrawal

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 1 Hour – 3 Days
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Neonatal Abstinence Syndrome

Interventions

Type	Name	Description
DRUG	Phenobarbital	Phenobarbital per os
DRUG	Chlorpromazine	Chlorpromazine per os
DRUG	Morphine	Morphine per os

Timeline

• Start date: 2001-06-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2016-06-23
• Last updated: 2020-01-07