Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

Overview

The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z scores and promote maturation of the gut microbiome at term corrected age.

Full Title of Study: “Early Life Protein-enriched Human Milk Diets to Increase Lean Body Mass Accretion and Diversity of the Gut Microbiome in Extremely Preterm Infants: a Randomized Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2, 2023

Detailed Description

Masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either a protein-enriched diet (intervention group) or a usual diet (control group) within the first 96 hours after birth.

Interventions

  • Procedure: Protein-enriched human milk diet
    • 1.2 g of human-based protein will be added to each 100 ml of human milk administered
  • Procedure: Usual human milk diet
    • Human-based protein will not be added to the human milk administered.

Arms, Groups and Cohorts

  • Experimental: Protein-enriched human milk diet
    • Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.
  • Active Comparator: Usual human milk diet
    • Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.

Clinical Trial Outcome Measures

Primary Measures

  • Fat-free mass(FFM)-for-age Z-score
    • Time Frame: 36 weeks or hospital discharge
    • FFM accretion will be estimated by air displacement plethysmography

Secondary Measures

  • Fat mass(FM)-for-age Z-score
    • Time Frame: 36 weeks or hospital discharge
    • FM accretion will be estimated by air displacement plethysmography
  • Body fat(BF)-for-age Z-score
    • Time Frame: 36 weeks or hospital discharge
    • Percent BF will be estimated by air displacement plethysmography
  • Anthropometric measurements
    • Time Frame: Birth to 36 weeks postmenstrual age or hospital discharge
    • Weight, length, and head circumference measurements at regular intervals
  • Growth rate
    • Time Frame: Birth to 36 weeks postmenstrual age or hospital discharge
    • Weight gain in g/kg/day
  • Number of participants with postnatal growth failure
    • Time Frame: 36 weeks or hospital discharge
    • Diagnosis of growth failure (weight < 10th percentile)
  • Number of participants with diagnosis of necrotizing enterocolitis
    • Time Frame: Birth to 120 days or discharge, whichever occurs first
    • Diagnosis of necrotizing enterocolitis stage 2 or 3
  • Number of participants with diagnosis of intestinal perforation
    • Time Frame: Birth to 120 days or discharge, whichever occurs first
    • Diagnosis of intestinal perforation
  • Death
    • Time Frame: Birth to 120 days
    • Death prior to 121 days of birth
  • Culture-proven sepsis
    • Time Frame: Birth to 120 days
    • Diagnosis of sepsis with positive blood cultures
  • Number of days alive and receiving full enteral feeding
    • Time Frame: Birth to 28 days
    • Total number of full enteral feeding days
  • Number of episodes of feeding intolerance
    • Time Frame: Birth to 28 days
    • Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination
  • Duration of hospital stay in days
    • Time Frame: Birth to 120 days or discharge, whichever occurs first
    • From day of admission to day of hospital discharge to home
  • Serum creatinine
    • Time Frame: Birth to 28 days
    • Highest serum creatinine value in the first 28 days after birth

Participating in This Clinical Trial

Inclusion Criteria

  • Gestational age ≤ 28 weeks of gestation – Postnatal age < 96 hours Exclusion Criteria:

  • Congenital malformations – Chromosomal anomalies – Terminal illness needing to limit or withhold support

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 4 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Collaborator
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ariel A. Salas, Principal Investigator – University of Alabama at Birmingham
  • Overall Official(s)
    • Ariel Salas, MD, MSPH, Principal Investigator, University of Alabama at Birmingham

Citations Reporting on Results

Salas AA, Gunawan E, Nguyen K, Reeves A, Argent V, Finck A, Carlo WA. Early Human Milk Fortification in Infants Born Extremely Preterm: A Randomized Trial. Pediatrics. 2023 Sep 1;152(3):e2023061603. doi: 10.1542/peds.2023-061603.

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