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 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

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: N/A

Maximum Age: 4 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ariel A. Salas, MD, Principal Investigator – University of Alabama at Birmingham
  • Overall Official(s)
    • Ariel Salas, MD, MSPH, Principal Investigator, University of Alabama at Birmingham
  • Overall Contact(s)
    • Ariel Salas, MD, MSPH, 205-934-4680, asalas@peds.uab.edu

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