How to Treat Opiate Withdrawal in Neonates

January 6, 2020 updated by: University of Zurich

Pharmacological Treatment of Narcotic Neonatal Withdrawal

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 3 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UZH-NAS01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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