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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
56
To increase protein content of human milk, a fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk. With this pragmatic approach, preterm infants assigned to the high protein supplementation group will receive \> 4.5 g/kg/day of enteral protein after establishment of full enteral feeding.
Infants assigned to the standard protein supplementation group will receive fortified human milk (\< 4.5 g/kg/day of enteral protein)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Infant body composition
Percent body fat estimated by air displacement plethysmography
Time frame: Assessed at 36 weeks of postmenstrual age or at 3 months of corrected age
Infant body composition
Percent body fat estimated by air displacement plethysmography
Time frame: Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)
Growth
Weekly weight gain in grams
Time frame: Birth to 3 months of corrected age
Length
Weekly length in cm
Time frame: Birth to 3 months of corrected age
Head circumference
Weekly head circumference in cm
Time frame: Birth to 3 months of corrected age
Body mass index
Weight and height will be combined to report BMI in kg/m\^2
Time frame: Birth to 3 months of corrected age
Necrotizing enterocolitis
Number of participants with diagnosis of necrotizing enterocolitis stage 2 or 3
Time frame: Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first
Death
Time frame: Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first
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