How to Treat Opiate Withdrawal in Neonates

Neonatal Abstinence Syndrome Clinical Trial

Official title:

Pharmacological Treatment of Narcotic Neonatal Withdrawal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810782
• Other study ID #: UZH-NAS01
• Status: Completed
• Phase: Phase 3
• Start date: June 2001
• Est. completion date: December 2007

Study information

• Verified date: December 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome

Intervention

Drug:
• Phenobarbital
Phenobarbital per os
• Chlorpromazine
Chlorpromazine per os
• Morphine
Morphine per os

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

References & Publications (1)

Zimmermann U, Rudin C, Duò A, Held L, Bucher HU; Swiss neonatal abstinence syndrome study group. Treatment of opioid withdrawal in neonates with morphine, phenobarbital, or chlorpromazine: a randomized double-blind trial. Eur J Pediatr. 2019 Nov 6. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of treatment	Treatment is reduced stepwise until withdrawal symptoms have gone	0 to 42 days
Secondary	Incidence of convulsions		Whole time of hospitalisation (up to 10 weeks)
Secondary	Weight gain		through study completion, up to 10 weeks
Secondary	Treatment failures (need for adding second medication)	Need for additional drug if investigational drug does not control withdrawal symptoms	through study completion, up to 10 weeks