Clinical trial NCT04325308: Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
Official title: 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: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prematurity; Extreme
Feeding Disorder Neonatal
Breast Milk Expression
Growth Failure
Microbial Colonization
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-03-27
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fat-free Mass(FFM)-For-age Z-score
timeFrame: 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
Secondary outcomes:
measure: Fat Mass(FM)-For-age Z-score
timeFrame: 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
measure: Body Fat(BF)-For-age Z-score
timeFrame: 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
measure: Anthropometric Measurements
timeFrame: Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first)
measure: Growth Rate
timeFrame: Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first)
measure: Number of Participants With Postnatal Growth Failure
timeFrame: 36 weeks or hospital discharge (whichever occurred first)
measure: Number of Participants With Diagnosis of Necrotizing Enterocolitis
timeFrame: From birth up to 120 days following birth
measure: Number of Participants With Diagnosis of Intestinal Perforation
timeFrame: From birth up to 120 days following birth
measure: Death
timeFrame: Birth to 120 days
measure: Culture-proven Sepsis
timeFrame: Birth to 120 days
measure: Number of Days Alive and Receiving Full Enteral Feeding
timeFrame: Birth to 28 days
measure: Number of Episodes of Feeding Intolerance
timeFrame: Birth to 28 days
measure: Duration of Hospital Stay in Days
timeFrame: Birth to 120 days or discharge, whichever occurs first
measure: Serum BUN
timeFrame: Birth to 28 days
Other outcomes:
measure: Changes in Intestinal Microbiome
timeFrame: Birth to 36 weeks postmenstrual age
measure: Cognitive Outcomes
timeFrame: 2 years of corrected age
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ariel Salas, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.