Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

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

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.

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.

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