How to Treat Opiate Withdrawal in Neonates

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Treatments: Chlorpromazine; Morphine; Phenobarbital

Criteria

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