Status:
COMPLETED
Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes
Lead Sponsor:
Laura Kair
Collaborating Sponsors:
Children's Miracle Network
The Gerber Foundation
Conditions:
Breastfeeding Duration
Exclusive Breastfeeding
Eligibility:
All Genders
24-48 years
Phase:
NA
Brief Summary
This study is a randomized controlled trial seeking to determine whether supplementing infants at risk for excessive neonatal weight loss with a small volume of human donor milk prophylactically in th...
Eligibility Criteria
Inclusion
- Gestational age greater than or equal to 37 weeks
- Weight loss greater than or equal to 5% (rounded to nearest whole percent) of birth weight in the first 36 hours after birth
- Chronologic age of 24-48 hours old at the time of study enrollment
Exclusion
- twins and higher level multiples
- infant has congenital or chromosomal anomalies that may affect feeding, diagnosed prior to study enrollment
- mother incarcerated
- mother's age \<18 years
- mother reports mature milk production prior to study enrollment
- mother does not speak English
- infants offered \> 1 supplemental feeding of formula or donor milk
- weight loss greater than 10%
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02221167
Start Date
July 1 2014
End Date
September 1 2016
Last Update
March 16 2018
Active Locations (1)
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1
University of Iowa Children's Hospital
Iowa City, Iowa, United States, 52242