The Milk, Growth and Microbiota Study

NCT03220282 | Suspended

• 1 other identifier: 17-21587
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Weight change

  Grams

  Between enrollment and 24 hours after enrollment

Secondary Outcomes (5)

• Bifidobacteria

  1 week and 1 month after enrollment

• Lactobacillus

  1 week and 1 month after enrollment

• Clostridium

  1 week and 1 month after enrollment

• Weight change

  Between enrollment and 48 hours after enrollment

• Weight change

  Between enrollment and 7 days of age

Study Arms (2)

Donor milk

ACTIVE COMPARATOR

Pasteurized donor breast milk

Other: Donor milk

Preterm infant formula

PLACEBO COMPARATOR

Preterm formula determined by clinical practice

Other: Preterm infant formula

Interventions

Donor milk OTHER

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.

Also known as: Donor breast milk

Donor milk

Preterm infant formula OTHER

Preterm formula determined by clinical practice

Also known as: Formula

Preterm infant formula

Eligibility Criteria

• Age: 1 Hour - 96 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Late preterm newborns \>=34 weeks and \<37 weeks gestation
• Breastfeeding
• Clinical team plans to start supplementation

You may not qualify if:

• Mothers are producing copious breast milk
• Birth weight \<2100gm
• Any maternal or infant contraindication to breastfeeding

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Davis: collaborator

Study Sites (1)

University of California, San Francisco Medical Center

San Francisco, California, 94122, United States

Location

MeSH Terms

Conditions

Premature Birth; Communicable Diseases; Breast Feeding

Interventions

Food, Formulated

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Foods, Specialized; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Valerie Flaherman, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participant, PI, enrolling nurse and clinical care team will not be blinded as to treatment assignment. Outcomes will be assessed by blinded investigators.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with 2 arms

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 18, 2017
• Study Start: October 30, 2017
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)