How to Treat Opiate Withdrawal in Neonates

University of Zurich (UZH)

Status and phase: Completed; Phase 3

Conditions: Neonatal Abstinence Syndrome

Treatments: Drug: Morphine; Drug: Chlorpromazine; Drug: Phenobarbital

Study type: Interventional

Funder types: Other

Identifiers

NCT02810782

UZH-NAS01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 1 hour to 3 days old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups

Phenobarbital

Experimental group

Description:

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

Treatment:

Drug: Phenobarbital

Chlorpromazine

Active Comparator group

Description:

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

Treatment:

Drug: Chlorpromazine

Morphine

Active Comparator group

Description:

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

Treatment:

Drug: Morphine