NCT03586102

Effect of Increased Enteral Protein on Body Composition of Preterm Infants

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 1 Day – 21 Days
• Healthy volunteers: Not accepted

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).

Conditions

• Premature Infant

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High protein supplementation	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.
DIETARY_SUPPLEMENT	Standard protein supplementation	Infants assigned to the standard protein supplementation group will receive fortified human milk (\< 4.5 g/kg/day of enteral protein)

Timeline

• Start date: 2018-08-23
• Primary completion: 2020-04-30
• Completion: 2025-04-24
• First posted: 2018-07-13
• Last updated: 2025-05-28

Locations

1 site across 1 country: United States