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Completed

NCT Number: NCT02810782

How to Treat Opiate Withdrawal in Neonates

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.

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Key information

Conditions

Neonatal Abstinence Syndrome Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

1 hour–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenobarbital

Drug

Phenobarbital per os

Other names: Phenobarbitone

Chlorpromazine

Drug

Chlorpromazine per os

Other names: Largactil

Morphine

Drug

Morphine per os

Other names: tinctura opii

Primary outcomes

  1. Duration of treatment

    Time frame: 0 to 42 days

    Treatment is reduced stepwise until withdrawal symptoms have gone

Secondary outcomes

  1. Incidence of convulsions

    Time frame: Whole time of hospitalisation (up to 10 weeks)

  2. Weight gain

    Time frame: through study completion, up to 10 weeks

  3. 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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Pharmacological Treatment of Narcotic Neonatal Withdrawal

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Jun 23, 2016
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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