Overview

This trial is active, not recruiting.

Conditions breastfeeding duration, exclusive breastfeeding, donor milk supplementation
Treatment donor milk
Sponsor University of Iowa
Collaborator Children's Miracle Network
Start date July 2014
End date September 2016
Trial size 60 participants
Trial identifier NCT02221167, 201406730

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
Infants in the exclusive breastfeeding group will continue to breastfeed.
(Active Comparator)
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)
donor milk donor breast milk
breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk "comes in."

Primary Outcomes

Measure
Any formula use at 1 week of age
time frame: 1 week

Secondary Outcomes

Measure
Exclusive breastfeeding
time frame: 3 months
Any breastfeeding at 3 months
time frame: 3 months
Any breastfeeding
time frame: 1 month
Exclusive breastfeeding
time frame: 1 month
Exclusive breastfeeding
time frame: 2 months
Any breastfeeding
time frame: 2 months
Any breastfeeding
time frame: 1 week

Eligibility Criteria

Male or female participants up to 48 hours old.

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%

Additional Information

Official title Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration & Exclusivity, a Randomized Controlled Trial
Principal investigator Laura R Kair, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Iowa.