Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration & Exclusivity, a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breastfeeding Duration
- Sponsor
- Laura Kair
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Any formula use at 1 week of age
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 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.
Investigators
Laura Kair
Adjunct Assistant Professor
University of Iowa
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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%
Outcomes
Primary Outcomes
Any formula use at 1 week of age
Time Frame: 1 week
Any formula intake within the last 24 hours.
Secondary Outcomes
- Exclusive breastfeeding(2 months)
- Any breastfeeding(1 week)
- Any breastfeeding at 3 months(3 months)