Protein Supplementation for Premature Infants

N/A

Waitlist Available

Led By Ariel A. Salas, MD, MSPH

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up birth to 3 months of corrected age

Awards & highlights

Study Summary

This trial is testing whether giving more protein to preterm babies who are fed human milk will reduce their body fat at 3 months old.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not detailed, increasing protein intake could potentially affect digestion, growth patterns, and metabolic processes in preterm infants. Close monitoring will help identify any adverse effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ birth to 3 months of corrected age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~birth to 3 months of corrected age

This trial's timeline: 3 weeks for screening, Varies for treatment, and birth to 3 months of corrected age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Body mass index

Death

Growth

+4 more

Other outcome measures

Changes in intestinal microbiome

Changes in metabolic pathways

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High protein supplementationExperimental Treatment1 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 supplementationActive Control1 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.

Do I qualify?Apply below to find out