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Donor Human Milk in Neonatal Abstinence Syndrome

NCT02182973 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2019-04-12

Study results available
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Summary

This study is designed to develop pilot data on the acceptability and benefit of donor human milk for infants undergoing pharmacologic treatment for NAS. Specifically, gastrointestinal (GI) sub-scores, as well as total scores, will be compared between infants historically fed formula and those enrolled in a 2-week donor human milk study period.

Purpose of study: to test the following null hypothesis:

Infants with a diagnosis of neonatal abstinence syndrome (NAS) due to in-utero exposure to opiates, fed donor human milk, will have similar GI/feeding sub-scores of the Finnegan scoring tool when compared to (historic) infants fed formula.

A rejection of the null hypothesis will be used to design a randomized trial of donor human milk in infants with NAS.

Conditions

  • Neonatal Abstinence Syndrome

Interventions

DIETARY_SUPPLEMENT

donor human milk

Infants with NAS requiring pharmacologic management will be fed donor human milk instead of formula for 2 weeks. GI-subscores from the Finnegan NAS Scoring system will be computed.

Sponsors & Collaborators

  • University of Louisville

    collaborator OTHER

  • Neolac Inc dba Medolac Laboratories

    lead INDUSTRY

Principal Investigators

  • Lori Devlin, DO, MHA · University of Louisville Division of Neonatal Medicine

  • Paula G Radmacher, MSPH, Ph.D. · University of Louisville Division of Neonatal Medicine

  • Scott Duncan, MD · University of Louisville Division of Neonatal Medicine

Eligibility

Min Age
38 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2017-08-01
Completion
2017-09-09

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 NCT02182973 on ClinicalTrials.gov