Donor Human Milk for Infant Gut Health
(PPDHM Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMeredith Brockway, PhD RN

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Calgary

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing whether giving donor human milk instead of formula to full-term infants can help maintain healthy gut bacteria. The study aims to see if this can improve the babies' sleep, growth, and overall health. The trial also looks at how this affects the mothers' mental health and breastfeeding success.

Eligibility Criteria

This trial is for full-term infants exposed to antibiotics during labor and their mothers who plan on breastfeeding. Eligible moms must understand English, agree to let their baby have donor milk, and be able to follow the study's rules. Babies with major birth defects affecting feeding or growth, or those needing long-term antibiotics beyond labor treatment can't join.

Inclusion Criteria

Vaginal delivery

Gestation greater than 37 weeks (full-term)

Completion of antibiotic protocol for GBS during labour

See 5 more

Exclusion Criteria

Diagnosed with clinically significant major congenital malformation that will interfere with breastfeeding or growth

No intention to breastfeed

I am on a long-term antibiotic treatment.

Treatment Details

Interventions

Donor Human Milk (Nutritional Replacement)

Trial OverviewThe study tests if using donated human milk instead of formula helps develop a healthier gut in babies given antibiotics at birth. It also looks at whether this affects infant sleep and growth, as well as maternal mood, confidence in breastfeeding, and rates of exclusive breastfeeding.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Donor Human MilkExperimental Treatment1 Intervention

Infants randomized to the intervention group will receive DHM each time supplementation is required for the first 7 days of life.

Group II: Standard Care (Infant Formula)Active Control1 Intervention

Infants randomized to the standard care group will receive formula each time supplementation is required for the first 7 days of life.