Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

The University of Alabama at Birmingham

Status: Active, not recruiting

Conditions: Feeding Disorder Neonatal; Growth Failure; Microbial Colonization; Breast Milk Expression; Prematurity; Extreme

Treatments: Procedure: Protein-enriched human milk diet; Procedure: Usual human milk diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04325308

300005089

K23HD102554 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 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.

Enrollment: 150 patients

Sex: All

Ages: 1 to 4 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

150 participants in 2 patient groups

Protein-enriched human milk diet

Experimental group

Description:

Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.

Treatment:

Procedure: Protein-enriched human milk diet

Usual human milk diet

Active Comparator group

Description:

Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.

Treatment:

Procedure: Usual human milk diet