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How to Treat Opiate Withdrawal in Neonates

NCT02810782 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-01-07

No results posted yet for this study

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.

Conditions

  • Neonatal Abstinence Syndrome

Interventions

DRUG

Phenobarbital

Phenobarbital per os

DRUG

Chlorpromazine

Chlorpromazine per os

DRUG

Morphine

Morphine per os

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Hans U Bucher, Prof · University of Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2007-12-31
Completion
2007-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02810782 on ClinicalTrials.gov