Skip to main content
NUTRITION 2023 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Back

Session: Milk to Meals: Feeding From Birth to Childhood (Oral 5)

(OR05-01-23) Increased Milk Protein To Accrue Critical Tissue (IMPACT) in Infants Born Extremely Preterm: A Masked, Randomized Trial

Sunday, July 23, 2023
8:00 AM – 8:12 AM ET
Location:  Constitution B

    Presenting Author(s)

  • Ariel Salas, MD, MSPH

    Associate Professor
    The University of Alabama
    Birmingham, Alabama, United States

    Disclosure(s): Mead Johnson: Advisory Committee/Board Member (Ongoing); Grant/Research Support (Ongoing); Speaker/Speaker's Bureau (Ongoing)
    WebMD: Speaker/Speaker's Bureau (Terminated)

    • Co-Author(s)

  • EG

    Emily Gunawan

    The University of Alabama

  • KN

    Kelly Nguyen

    The University of Alabama

  • AR

    Audrey Reeves

    The University of Alabama

  • VA

    Victoria Argent

    The University of Alabama

  • AF

    Amber Finck

    The University of Alabama

  • WC

    Waldemar Carlo

    The University of Alabama

Disclosure(s):
Ariel Salas, MD, MSPH: Mead Johnson: Advisory Committee/Board Member (Ongoing); Grant/Research Support (Ongoing); Speaker/Speaker's Bureau (Ongoing)
WebMD: Speaker/Speaker's Bureau (Terminated)
Objectives: To test the hypothesis that in infants born extremely preterm birth (28 weeks of gestation or less), protein-enriched human milk diets initiated soon after birth increase fat-free mass (FFM) accretion at term equivalent age.

Methods: This was a masked, randomized trial. Extremely preterm infants fed human milk were randomized to receive either a fortified human milk diet (intervention group) or a usual, unfortified human milk diet (control group) within the first 96 hours after birthStarting on feeding day 2, extremely preterm infants fed maternal or donor milk were randomized to receive either a diet fortified with a human-based product (intervention group) or a standard, unfortified diet (control group). This practice continued until the feeding day when a standard bovine-based fortifier was ordered (approximately postnatal day 14). Caregivers were masked. The primary outcome was FFM-for-age z score  measured using air-displacement plethysmography at 36 weeks of postmenstrual age (PMA).

Results: A total of 150 infants were randomized between 2020 and 2022. The mean birthweight of study participants was 795 ± 250 g, and the median gestational age was 26 weeks. The primary outcome was assessed in 105 of 128 (82%) infants who completed the follow-up period. FFM-for-age z scores did not differ between groups (mean difference: -0.1; 95% CI: -0.7 to 0.4). Length velocity rates in cm/week from birth to 36 weeks PMA were higher in the intervention group (mean difference: 0.1; 95% CI: 0 to 0.2). Declines in head circumference-for-age z score from birth to 36 weeks PMA were less pronounced in the intervention group (mean difference: 0.4; 95% CI: 0.1 to 0.8; p=0.01)

Conclusions: In infants born extremely preterm, human milk diets fortified soon after birth do not increase FFM accretion at term equivalent age. Early provision of fortified human milk within the first 96 hours after birth may increase length velocity rates and minimize declines in head circumference-for age z scores from birth to term equivalent age.

Funding Sources: This trial was funded by NICHD (K23HD102554) and registered at clinicaltrials.gov (NCT04325308).