Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration & Exclusivity, a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Any formula use at 1 week of age
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 24 Hours to 48 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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%
Arms & Interventions
Exclusive breastfeeding
Infants in the exclusive breastfeeding group will continue to breastfeed.
Donor Milk
Infants in this arm will continue to breastfeed and will be given 10 ml of donor breast milk by syringe after each breastfeeding until their mother's milk "comes in." (until the onset of lactogenesis II)
Intervention: Donor Milk (Other)
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)
- Exclusive breastfeeding(3 months)
- Any breastfeeding(1 month)
- Exclusive breastfeeding(1 month)
- Any breastfeeding(2 months)
Investigators
Laura Kair
Adjunct Assistant Professor
University of Iowa