N/A
Completed N=21
Donor Human Milk in Neonatal Abstinence Syndrome
Source: ClinicalTrials.gov NCT02182973 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Percentage of Infants Achieving a GI Subscore >2 Over the Study Period — 39; 61 Percentage of participants — p=0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Infants Achieving a GI Subscore >2 Over the Study Period |
39; 61 | 0.001 sig |
| SECONDARY Weight Change at 2 Weeks |
19.1; 20.5 | 0.875 |
| SECONDARY Head Circumference Change at 2 Weeks |
0.4; 0.6 | 0.025 sig |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Preterm infants (<37 completed weeks at birth)
- Infants with intrauterine growth restriction (BW <10th percentile for gestational age)
- Mother is providing her own milk
Data sourced from ClinicalTrials.gov (NCT02182973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.