NCT02221167

Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes

Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration & Exclusivity, a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Laura Kair · Academic / Other
• Sex: All
• Age: 24 Hours – 48 Hours
• Healthy volunteers: Not accepted

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 the first 1-3 days of life, before maternal mature milk production (before mom's milk "comes in") will decrease the incidence of formula use at 1 week and 1, 2, and 3 months of life and increase the rate of exclusive breastfeeding in this high-risk population. We hypothesize that supplementation of term infants who have lost greater than or equal to 5% birth weight by 36 hours of age with a small volume of donor breast milk following feeds, until mature milk production, will result in decreased supplemental formula use at 1 week and increased exclusive as well as any breastfeeding at 1 week and 1, 2, and 3 months. This study's specific aims are to compare the effectiveness of encouraging in-hospital exclusive breastfeeding with offering early small-volume donor milk supplementation in a population of infants at risk for excessive neonatal weight loss with goals of 1) decreasing the incidence of formula supplementation at 1 week of life and 2) improving breastfeeding duration.

Conditions

• Breastfeeding Duration
• Exclusive Breastfeeding
• Donor Milk Supplementation

Interventions

Type	Name	Description
OTHER	Donor Milk	breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk "comes in."

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-07-01
• Completion: 2016-09-01
• First posted: 2014-08-20
• Last updated: 2018-03-16

Locations

1 site across 1 country: United States