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Completed

NCT Number: NCT03586102

Effect of Increased Enteral Protein on Body Composition of Preterm Infants

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.

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Key information

Conditions

Premature Infant Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High protein supplementation

Dietary Supplement

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.

Standard protein supplementation

Dietary Supplement

Infants assigned to the standard protein supplementation group will receive fortified human milk (< 4.5 g/kg/day of enteral protein)

Primary outcomes

  1. Infant body composition

    Time frame: Assessed at 36 weeks of postmenstrual age or at 3 months of corrected age

    Percent body fat estimated by air displacement plethysmography

Secondary outcomes

  1. Infant body composition

    Time frame: Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)

    Percent body fat estimated by air displacement plethysmography

  2. Growth

    Time frame: Birth to 3 months of corrected age

    Weekly weight gain in grams

  3. Length

    Time frame: Birth to 3 months of corrected age

    Weekly length in cm

  4. Head circumference

    Time frame: Birth to 3 months of corrected age

    Weekly head circumference in cm

  5. Body mass index

    Time frame: Birth to 3 months of corrected age

    Weight and height will be combined to report BMI in kg/m^2

  6. Necrotizing enterocolitis

    Time frame: Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first

    Number of participants with diagnosis of necrotizing enterocolitis stage 2 or 3

  7. Death

    Time frame: Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first

Other outcomes

  1. Changes in intestinal microbiome

    Time frame: Birth to 3 months of corrected age

    Determined by molecular analyses of bacteria in fecal samples

  2. Changes in metabolic pathways

    Time frame: Birth to 3 months of corrected age

    Determined by molecular analyses of serum samples

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Children's Health System, Alabama

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2025
First posted
Jul 13, 2018
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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