Donor Human Milk in Neonatal Abstinence Syndrome

Completed

Conditions studied: Neonatal Abstinence Syndrome

In brief

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.

Key facts

Study ID: NCT02182973
Run by: Neolac Inc dba Medolac Laboratories
People needed: 12
Starts: 2014-06-01
Expected to finish: 2017-09-09
Last updated by the study team: 2019-04-12

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Term infants (>37 completed weeks) with a diagnosis of NAS, due to maternal use of opiates (only)
Infants will have had moderate to severe NAS symptoms (Finnegan scores >8) that required pharmacologic therapy but have been stabilized (captured) on oral morphine (Finnegan scores less than 8 for 24 hours)
Breastfeeding is contraindicated or the mother has chosen formula feeding for her baby

You may not qualify if…

Preterm infants (<37 completed weeks at birth)
Infants with intrauterine growth restriction (BW <10th percentile for gestational age)
Mother is providing her own milk

Where it is running

University of Louisville — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.