How to Treat Opiate Withdrawal in Neonates

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT02810782

Collaborator

(none)

120

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neonatal Abstinence Syndrome	Drug: Phenobarbital Drug: Chlorpromazine Drug: Morphine	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Treatment

Official Title:

Pharmacological Treatment of Narcotic Neonatal Withdrawal

Study Start Date :

Jun 1, 2001

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phenobarbital Phenobarbitone loading dose 10 mg/kg body weight maintenance dose 0.83 mg/kg body weight every 4 hours	Drug: Phenobarbital Phenobarbital per os Other Names: Phenobarbitone
Active Comparator: Chlorpromazine Chlorpromazine loading dose 0.5 mg/kg body weight maintenance dose 0.25 mg/kg every 4 hours	Drug: Chlorpromazine Chlorpromazine per os Other Names: Largactil
Active Comparator: Morphine Morphine (tinctura opii) 0.25 mg/kg body weight every 4 hours	Drug: Morphine Morphine per os Other Names: tinctura opii

Arm

Intervention/Treatment

Experimental: Phenobarbital

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

Drug: Phenobarbital

Phenobarbital per os

Other Names:

Phenobarbitone

Active Comparator: Chlorpromazine

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

Drug: Chlorpromazine

Chlorpromazine per os

Other Names:

Largactil

Active Comparator: Morphine

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

Drug: Morphine

Morphine per os

Other Names:

tinctura opii

Outcome Measures

Primary Outcome Measures

Duration of treatment [0 to 42 days]
Treatment is reduced stepwise until withdrawal symptoms have gone

Secondary Outcome Measures

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]
Need for additional drug if investigational drug does not control withdrawal symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Hour to 3 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Zurich

Investigators

Study Chair: Hans U Bucher, Prof, University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Zurich

ClinicalTrials.gov Identifier:

NCT02810782

Other Study ID Numbers:

UZH-NAS01

First Posted:

Jun 23, 2016

Last Update Posted:

Jan 7, 2020

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by University of Zurich

opiate dependence

withdrawal

newborn

Additional relevant MeSH terms:

Neonatal Abstinence Syndrome

Morphine

Phenobarbital

Chlorpromazine

Study Results

No Results Posted as of Jan 7, 2020