Effect of Increased Enteral Protein on Body Composition of Preterm Infants

The University of Alabama at Birmingham

Status: Completed

Conditions: Premature Infant

Treatments: Dietary Supplement: High protein supplementation; Dietary Supplement: Standard protein supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03586102

300000681

Details and patient eligibility

About

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.

Full 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).

Enrollment: 56 patients

Sex: All

Ages: 1 to 21 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups

High protein supplementation

Experimental group

Description:

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.

Treatment:

Dietary Supplement: High protein supplementation

Standard protein supplementation

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Standard protein supplementation