Effect of Increased Enteral Protein on Body Composition of Preterm Infants

Not Applicable

Active, not recruiting

• Conditions: Premature Infant
• Interventions: Dietary Supplement: Standard protein supplementation; Dietary Supplement: High protein supplementation

• 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).

Study Timeline

• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-13
• Study Start: 2018-08-23
• Primary Completion: 2020-04-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Gestational age between 25 and 28 weeks of gestation
• Feeding volumes of ≥120 ml/kg/day before or on postnatal day 14.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard protein supplementation	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.
High protein supplementation	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.

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