Donor Human Milk in Neonatal Abstinence Syndrome (DHM&NAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02182973|
Recruitment Status : Completed
First Posted : July 8, 2014
Results First Posted : April 12, 2019
Last Update Posted : April 12, 2019
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.
|Condition or disease||Intervention/treatment|
|Neonatal Abstinence Syndrome||Dietary Supplement: donor human milk|
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||Donor Human Milk for Infants With Neonatal Abstinence Syndrome|
|Actual Study Start Date :||June 2014|
|Actual Primary Completion Date :||August 1, 2017|
|Actual Study Completion Date :||September 9, 2017|
Infants identified with neonatal abstinence syndrome requiring pharmacologic management and who will not be fed own mother's milk
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.
Other Name: Co-op donor milk (Medolac Laboratories)
- Percentage of Infants Achieving a GI Subscore >2 Over the Study Period [ Time Frame: 2 weeks ]Minimum score:0; Maximum score 13. Higher scores mean more GI distress
- Weight Change at 2 Weeks [ Time Frame: 2 weeks ]Change in weight from study day 1 to study day 14 (grams/day) Weight day 14 - weight day 1 divided by 14
- Head Circumference Change at 2 Weeks [ Time Frame: 2 weeks ]Change in head circumference from day 1 to day 14 (cm/wk)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182973
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40292|
|Principal Investigator:||Lori Devlin, DO, MHA||University of Louisville Division of Neonatal Medicine|
|Study Director:||Paula G Radmacher, MSPH, Ph.D.||University of Louisville Division of Neonatal Medicine|
|Principal Investigator:||Scott Duncan, MD||University of Louisville Division of Neonatal Medicine|