Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes

Laura Kair

Status: Completed

Conditions: Exclusive Breastfeeding; Breastfeeding Duration; Donor Milk Supplementation

Treatments: Other: Donor Milk

Study type: Interventional

Funder types: Other

Identifiers

NCT02221167

201406730

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 24 to 48 hours old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Exclusive breastfeeding

No Intervention group

Description:

Infants in the exclusive breastfeeding group will continue to breastfeed.

Donor Milk

Active Comparator group

Description:

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)

Treatment:

Other: Donor Milk