How to Treat Opiate Withdrawal in Neonates

Pharmacological Treatment of Narcotic Neonatal Withdrawal

Sponsors

Lead Sponsor: University of Zurich

Source University of Zurich
Brief 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.

Overall Status Completed
Start Date 2001-06-01
Completion Date 2007-12-01
Primary Completion Date 2007-12-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Duration of treatment 0 to 42 days
Secondary Outcome
Measure Time Frame
Incidence of convulsions Whole time of hospitalisation (up to 10 weeks)
Weight gain through study completion, up to 10 weeks
Treatment failures (need for adding second medication) through study completion, up to 10 weeks
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: Phenobarbital

Description: Phenobarbital per os

Arm Group Label: Phenobarbital

Other Name: Phenobarbitone

Intervention Type: Drug

Intervention Name: Chlorpromazine

Description: Chlorpromazine per os

Arm Group Label: Chlorpromazine

Other Name: Largactil

Intervention Type: Drug

Intervention Name: Morphine

Description: Morphine per os

Arm Group Label: Morphine

Other Name: tinctura opii

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

N/A

Maximum Age:

3 Days

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Hans U Bucher, Prof Study Chair University of Zurich
Verification Date

2019-12-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Phenobarbital

Type: Experimental

Description: Phenobarbitone loading dose 10 mg/kg body weight maintenance dose 0.83 mg/kg body weight every 4 hours

Label: Chlorpromazine

Type: Active Comparator

Description: Chlorpromazine loading dose 0.5 mg/kg body weight maintenance dose 0.25 mg/kg every 4 hours

Label: Morphine

Type: Active Comparator

Description: Morphine (tinctura opii) 0.25 mg/kg body weight every 4 hours

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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