How to Treat Opiate Withdrawal in Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome

NCT07278375

Neonatal Opioid Withdrawal Syndrome

NOT_YET_RECRUITING

NAS Treatment - Opiate Versus Non-Opiate

NCT01734551

Neonatal Abstinence Syndrome

COMPLETED PHASE4

Improving Outcomes in Neonatal Abstinence Syndrome

NCT01958476

Neonatal Abstinence Syndrome Neonatal Opioid Withdrawal

COMPLETED PHASE3

The Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome

NCT01754324

Neonatal Abstinence Syndrome

COMPLETED

Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach

NCT05980260

Neonatal Opiate Withdrawal Syndrome

ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Neonatal Abstinence Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phenobarbital

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

Group Type EXPERIMENTAL

Phenobarbital

Intervention Type DRUG

Phenobarbital per os

Chlorpromazine

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

Group Type ACTIVE_COMPARATOR

Chlorpromazine

Intervention Type DRUG

Chlorpromazine per os

Morphine

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

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Morphine per os

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Phenobarbital

Phenobarbital per os

Intervention Type DRUG

Chlorpromazine

Chlorpromazine per os

Intervention Type DRUG

Morphine

Morphine per os

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Phenobarbitone Largactil tinctura opii

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

1 Hour

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No