UAB - Center for Clinical and Translational Science

Effect of Increased Enteral Protein on Body Composition of Preterm Infants

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.

Condition

Premature Infant

Eligibility

Eligible Ages: Between 1 Day and 21 Days
Eligible Genders: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Clinicians and technicians responsible for the assessment of infant body composition will be masked.

Arm Groups

Arm	Description	Assigned Intervention
Experimental High protein supplementation	Infants will receive a diet that consists of mother's own milk or donor human milk and bovine-based human milk fortifier plus a fixed amount of commercially available hydrolyzed bovine protein. The study intervention will begin the day after fortification is ordered and will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first.	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.
Active Comparator Standard protein supplementation	Infants will receive a standard diet that consists of mother's own milk or donor human milk (DHM) and bovine-based human milk fortifier. The study intervention will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first.	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)

More Details

Status: Active, not recruiting
Sponsor: University of Alabama at Birmingham

Study Contact

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.