Effect of Increased Enteral Protein on Body Composition of Preterm Infants
- Conditions
- Premature Infant
- Registration Number
- NCT03586102
- Lead Sponsor
- University of Alabama at Birmingham
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- Gestational age between 25 and 28 weeks of gestation
- Feeding volumes of ≥120 ml/kg/day before or on postnatal day 14.
- Necrotizing enterocolitis (NEC) stage 2 or greater.
- Gastrointestinal or neurologic malformations.
- Terminal illness needing to limit or withhold support will be exclusion criteria.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Infant body composition Assessed at 36 weeks of postmenstrual age or at 3 months of corrected age Percent body fat estimated by air displacement plethysmography
- Secondary Outcome Measures
Name Time Method Length Birth to 3 months of corrected age Weekly length in cm
Necrotizing enterocolitis Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first Number of participants with diagnosis of necrotizing enterocolitis stage 2 or 3
Infant body composition Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first) Percent body fat estimated by air displacement plethysmography
Body mass index Birth to 3 months of corrected age Weight and height will be combined to report BMI in kg/m\^2
Growth Birth to 3 months of corrected age Weekly weight gain in grams
Head circumference Birth to 3 months of corrected age Weekly head circumference in cm
Death Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first
Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States