Protein-Enriched Human Milk for Premature Infants

Recruiting in Palo Alto (17 mi)

Overseen byAriel A. Salas, MD, MSPH

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing whether giving extremely preterm infants milk with extra protein helps them grow stronger and develop healthier guts compared to regular milk. Some infants will receive milk with extra protein shortly after birth, while others will receive regular milk. Researchers hope to see better growth and gut health in the babies who get the extra protein. Protein supplementation of human milk has been studied to improve growth and development in preterm infants, but results have been mixed.

Research Team

Ariel A. Salas, MD, MSPH

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for extremely preterm infants born at or before 28 weeks of gestation and are less than 96 hours old. It's not suitable for babies with chromosomal anomalies, significant congenital malformations, or those with a terminal illness where medical support would be limited.

Inclusion Criteria

My baby is less than 4 days old.

Gestational age ≤ 28 weeks of gestation

Exclusion Criteria

Congenital malformations

My condition involves chromosomal anomalies.

Terminal illness needing to limit or withhold support

Treatment Details

Interventions

Protein-enriched Human Milk Diet (Protein Supplement)
Usual Human Milk Diet (Nutrition)

Trial OverviewThe study is testing if feeding extremely preterm infants a protein-enriched human milk diet versus the usual human milk diet can improve their growth without fat gain and help develop their gut bacteria by the time they reach their due date.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Protein-enriched human milk dietExperimental Treatment1 Intervention

Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.

Group II: Usual human milk dietActive Control1 Intervention

Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.