Effect of Increased Enteral Protein on Body Composition of Preterm Infants



Status:Recruiting
Healthy:No
Age Range:Any
Updated:8/26/2018
Start Date:August 23, 2018
End Date:September 2019
Contact:Ariel A. Salas, MD, MSPH
Email:asalas@peds.uab.edu
Phone:205-934-4680

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Trial Summary
Trial Overview
Inclusion Criteria

Effect of Increased Enteral Protein on Body Composition of Preterm Infants: A Randomized Trial

The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein
intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.

Qualifying participants will be randomly assigned to receive either standard protein
supplementation (control group) or high protein supplementation (intervention group).

Intervention group: A fixed amount of commercially available hydrolyzed bovine protein will
be added to fortified human milk after establishment of full enteral feeding.

Control group: Hydrolyzed bovine protein will not be added to fortified human milk after
establishment of full enteral feeding.

If parent agrees, stool "dirty" diapers will be collected 2 times (at the time of hospital
discharge and at 3 months of corrected age).

Inclusion Criteria:

- Gestational age between 25 and 28 weeks of gestation

- Feeding volumes of ≥120 ml/kg/day before or on postnatal day 14.

Exclusion Criteria:

- Necrotizing enterocolitis (NEC) stage 2 or greater.

- Gastrointestinal or neurologic malformations.

- Terminal illness needing to limit or withhold support will be exclusion criteria.
We found this trial at
1
site
University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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mi
from
Birmingham, AL
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