The Milk, Growth and Microbiota Study

Summary

Late preterm infants, who are born at 34, 35 or 36 weeks gestation, often have difficulty feeding, establishing growth, and fighting off infection. Breastfeeding provides improved nutrition to help fight infection, in part because breast milk encourages the growth of healthy bacteria (microbiota) in the infant's intestine. However, when mothers give birth preterm, their breasts are usually not quite ready to make milk; it can take several days to have enough breast milk to match a baby's nutritional needs. If there is not yet enough breast milk, formula is often used. However, formula can interfere with the growth of healthy intestinal bacteria. An alternate nutritional option is donor milk from a certified milk bank, which is available in all neonatal intensive care units (NICUs) in San Francisco. However, no scientific studies have yet studied donor milk for late preterm infants, so currently all San Francisco NICUs (as well as the large majority of NICUs nationwide) reserve donor milk for infants born at \<34 weeks. This study's investigators therefore propose the "Milk, Growth and Microbiota (MGM) Study," a randomized controlled trial to compare banked donor milk to formula for breastfeeding late preterm infants born in San Francisco. Once enrolled in MGM, infants will be randomly assigned to receive either formula or banked donor milk if they need additional nutrition until their mothers are making enough milk. After enrolling the babies, investigators will weigh them daily to assess their growth. The investigators will also collect infant bowel movements at baseline, 1 week and 1 month to determine whether donor milk vs. formula impacts the type of bacteria in the baby's intestine. If the study's results show that donor milk optimizes growth while helping establish healthy bacteria in the baby's intestine, donor milk might be postnatal strategy to bolster neonatal nutrition for late preterm infants.

Conditions

• Preterm Infant
• Growth Delay
• Microbial Colonization
• Breastfeeding
• Breast Milk Substitute Intolerance

Interventions

OTHER

Donor milk

For late preterm newborns who are breastfeeding and whose mothers are not making enough breast milk yet to meet their nutritional needs, the study will compare the intervention of banked donor breast milk with the control of preterm infant formula.

OTHER

Preterm infant formula

Preterm formula determined by clinical practice

Sponsors & Collaborators

• University of California, Davis

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Valerie Flaherman, MD, MPH · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Hour

Max Age

96 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-30

Primary Completion

2025-12-31

Completion

2026-01-31

Countries

• United States

Study Locations