Protein Supplementation for Premature Infants

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Necrotizing enterocolitis, Malformations, Terminal illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 7 weeks

56 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if adding extra protein to the milk of very premature babies helps them grow with less body fat. The special protein comes from cow's milk and is added to their usual fortified milk.

Research Team

Ariel A. Salas, MD, MSPH

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for extremely preterm infants born between 25 and 28 weeks of gestation who are being fed human milk and can handle feeding volumes of at least 120 ml/kg/day by the second week. Infants with severe intestinal disease (NEC stage 2+), life-limiting conditions, or malformations in the gut or nervous system cannot participate.

Inclusion Criteria

Babies who are getting fed more than 120 ml of milk per kilogram of their body weight each day by the time they are 14 days old.

Gestational age between 25 and 28 weeks of gestation

Exclusion Criteria

My condition is NEC stage 2 or higher.

I have abnormalities in my digestive system or nervous system.

Terminal illness needing to limit or withhold support will be exclusion criteria.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants receive either standard or high protein supplementation until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first

Up to 7 weeks

Follow-up

Participants are monitored for body composition, growth, and other health metrics

3 months

Treatment Details

Interventions

• High protein supplementation
• Standard protein supplementation

Trial Overview The study is testing whether giving very premature babies more protein than usual in their diet will result in less body fat when they reach three months old. Babies will receive either standard or high levels of protein supplementation to see which affects body composition better.

Participant Groups

Group I: High protein supplementation Experimental Treatment 1 Intervention

Infants will receive a diet that consists of mother's own milk or donor human milk and bovine-based human milk fortifier plus a fixed amount of commercially available hydrolyzed bovine protein. The study intervention will begin the day after fortification is ordered and will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first.

Group II: Standard protein supplementation Active Control 1 Intervention

Infants will receive a standard diet that consists of mother's own milk or donor human milk (DHM) and bovine-based human milk fortifier. The study intervention will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Children's Health System, Alabama

Collaborator

Trials

6

Recruited

610+