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Treatment of Neonatal Abstinence Syndrome

NCT01723722 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-11-27

Study results available
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Summary

This study compares treatment of Neonatal Abstinence Syndrome (NAS) with two different drugs for the difference in the length of treatment. This is a randomized, open-label comparison of phenobarbital and methadone versus phenobarbital and diluted deodorized tincture of opium (dDTO) where phenobarbital is the initial drug used to stabilize neonatal withdrawal.

Conditions

  • Neonatal Abstinence Syndrome

Interventions

DRUG

Methadone

Concentration is 1mg/mL administered every 12 hours given on sliding scale in response to last NAS score.

DRUG

Diluted Deodorized Tincture of Opium

Concentration is 1:24 dilution for a concentration of 0.4%

Sponsors & Collaborators

  • Eastern Maine Medical Center

    lead OTHER

Principal Investigators

  • Mark S. Brown, MD · Eastern Maine Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
6 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

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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 NCT01723722 on ClinicalTrials.gov