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RCT of High- vs. Standard-Calorie Formula for Methadone-Exposed Infants

NCT02178189 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2014-06-30

No results posted yet for this study

Summary

Neonatal abstinence syndrome (NAS) symptoms contribute to poor infant weight gain. Early caloric enhancement for infants exposed to methadone is inexpensive, readily available, easy to implement and could improve early outcomes for these high-risk infants. We will conduct a preliminary randomized clinical trial of high-calorie vs. standard-calorie formula for methadone exposed infants to evaluate the adequacy of recruitment, protocol feasibility and estimates of whether high-calorie formula results in more normal patterns of weight loss and gain, less severe NAS symptoms and shorter hospital stays.

Conditions

  • Neonatal Abstinence Syndrome

Interventions

OTHER

High Calorie Infant formula

Infants were randomized to be fed high calorie formula from 72 hours of life until age 21 days.

OTHER

Standard Calorie Infant Formula

Infants were randomized to be fed standard calorie formula from 72 hours of life until age 21 days.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Debra L Bogen, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-04-30
Completion
2013-12-31

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 NCT02178189 on ClinicalTrials.gov