Birmingham, Alabama 35233

  • Premature Infant

Purpose:

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.


Study summary:

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).


Criteria:

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.


NCT ID:

NCT03586102


Primary Contact:

Principal Investigator
Ariel A. Salas, MD, MSPH
University of Alabama at Birmingham


Backup Contact:

N/A


Location Contact:

Birmingham, Alabama 35233
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 18, 2021

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