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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Premature Infant
• Intervention / Treatment: Dietary supplement: High protein supplementation; Dietary supplement: Standard protein supplementation

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant body composition	Percent body fat estimated by air displacement plethysmography	Assessed at 36 weeks of postmenstrual age or at 3 months of corrected age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth	Weekly weight gain in grams	Birth to 3 months of corrected age
Infant body composition	Percent body fat estimated by air displacement plethysmography	Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)
Length	Weekly length in cm	Birth to 3 months of corrected age
Head circumference	Weekly head circumference in cm	Birth to 3 months of corrected age
Body mass index	Weight and height will be combined to report BMI in kg/m^2	Birth to 3 months of corrected age
Necrotizing enterocolitis	Number of participants with diagnosis of necrotizing enterocolitis stage 2 or 3	Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first
Death		Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in intestinal microbiome	Determined by molecular analyses of bacteria in fecal samples	Birth to 3 months of corrected age
Changes in metabolic pathways	Determined by molecular analyses of serum samples	Birth to 3 months of corrected age

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Children's Health System, Alabama
• Investigators: Principal Investigator: Ariel A. Salas, MD, MSPH, University of Alabama at Birmingham

Publications and helpful links

General Publications

• Salas AA, Jerome M, Finck A, Razzaghy J, Chandler-Laney P, Carlo WA. Body composition of extremely preterm infants fed protein-enriched, fortified milk: a randomized trial. Pediatr Res. 2022 Apr;91(5):1231-1237. doi: 10.1038/s41390-021-01628-x. Epub 2021 Jun 28.

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2018
• Primary Completion (Actual): April 30, 2020
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Protein supplementation; Human milk fortification
• Other Study ID Numbers: 300000681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No