The Milk, Growth and Microbiota Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Milk Substitute Intolerance
- Breastfeeding
- Growth Delay
- Microbial Colonization
- Preterm Infant
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized controlled trial with 2 armsMasking: Single (Outcomes Assessor)Masking Description: Participant, PI, enrolling nurse and clinical care team will not be blinded as to treatment assignment. Outcomes will be assessed by blinded investigators.Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 96 years
- Gender
- Both males and females
Description
In the U.S., 8% of all births occur between 34 0/7 and 36 6/7 weeks gestation and are regarded as late preterm birth. Compared to term newborns, late preterm newborns have a much higher risk of morbidity and mortality, in part because of difficulty establishing feeding and growth. Breastfeeding opti...
In the U.S., 8% of all births occur between 34 0/7 and 36 6/7 weeks gestation and are regarded as late preterm birth. Compared to term newborns, late preterm newborns have a much higher risk of morbidity and mortality, in part because of difficulty establishing feeding and growth. Breastfeeding optimizes the nutrition of these infants by supporting growth and establishing a healthy intestinal microbiota. However, maternal breast milk production is often delayed after preterm birth, which can hamper optimal growth. When this occurs, clinicians may use formula to supplement breastfeeding. However, formula alters neonatal intestinal microbiota and can impede some of the benefits of a human milk diet. Donor milk from a certified milk bank could possibly be used instead of formula for supplementation prior to the onset of copious maternal milk production. However, the use of banked donor milk has never been studied in late preterm infants. The aim of this proposal is to report the effects of banked donor milk vs. formula on growth and on intestinal microbiota among late preterm, breastfeeding newborns who require additional nutrition before copious maternal milk is available. This study's investigators therefore propose a randomized, controlled trial enrolling late preterm newborns. Newborns will be randomly assigned either to breastfeed with additional formula feedings, or to breastfeed with additional donor milk feedings. The study's outcomes will be: (1) growth (rate of weight change), and (2) intestinal microbiota. If the study finds that temporary use of donor milk supports growth and maintains healthy intestinal microbiota until copious maternal milk becomes available, temporary use of donor milk might be a postnatal strategy to bolster neonatal nutrition and optimize nutritional support and growth for late preterm infants.
Tracking Information
- NCT #
- NCT03220282
- Collaborators
- University of California, Davis
- Investigators
- Principal Investigator: Valerie Flaherman, MD, MPH University of California, San Francisco