Clinical trial NCT03586102: Effect of Increased Enteral Protein on Body Composition of Preterm Infants
Official title: Effect of Increased Enteral Protein on Body Composition of Preterm Infants: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infant
Keywords: Protein supplementation
Human milk fortification
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Children's Health System, Alabama
First posted: 2018-07-13
Enrollment: 56
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Infant body composition
timeFrame: Assessed at 36 weeks of postmenstrual age or at 3 months of corrected age
Secondary outcomes:
measure: Infant body composition
timeFrame: Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)
measure: Growth
timeFrame: Birth to 3 months of corrected age
measure: Length
timeFrame: Birth to 3 months of corrected age
measure: Head circumference
timeFrame: Birth to 3 months of corrected age
measure: Body mass index
timeFrame: Birth to 3 months of corrected age
measure: Necrotizing enterocolitis
timeFrame: Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first
measure: Death
timeFrame: Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first
Other outcomes:
measure: Changes in intestinal microbiome
timeFrame: Birth to 3 months of corrected age
measure: Changes in metabolic pathways
timeFrame: Birth to 3 months 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 A. Salas, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salas AA, Jerome M, Finck A, Razzaghy J, Chandler-Laney P, Carlo WA. Body composition of extremely preterm infants fed protein-enriched, fortified milk: a randomized trial. Pediatr Res. 2022 Apr;91(5):1231-1237. doi: 10.1038/s41390-021-01628-x. Epub 2021 Jun 28.