Effect of Increased Enteral Protein on Body Composition of Preterm Infants: A Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Premature Infant
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Infant body composition
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Ariel A. Salas
Assistant Professor
University of Alabama at Birmingham
Eligibility 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.
Outcomes
Primary Outcomes
Infant body composition
Time Frame: Assessed at 36 weeks of postmenstrual age or at 3 months of corrected age
Percent body fat estimated by air displacement plethysmography
Secondary Outcomes
- Length(Birth to 3 months of corrected age)
- Necrotizing enterocolitis(Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first)
- Infant body composition(Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first))
- Body mass index(Birth to 3 months of corrected age)
- Growth(Birth to 3 months of corrected age)
- Head circumference(Birth to 3 months of corrected age)
- Death(Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first)