Background
Human milk is recommended for all very low birth weight infants. Breastmilk is highly variable in nutrient content, failing to meet the nutritional demands of this group. Fortification of human milk is recommended to prevent extrauterine growth retardation and associated poor neurodevelopmental outcome. However, standard fortification with fixed dose multicomponent fortifier does not account for the variability in milk composition. Targeted fortification is a promising alternative and needs further investigation.
Methods
This randomized controlled trial will recruit preterm infants (â€â32âweeks of gestation) within the first 7âdays of life. After reaching 80âml/kg/day of enteral feeding, patients will be randomized to receive standard fortification (HMF, Nutricia) or targeted fortification (modular components: Bebilon Bialka, Nutriciaâprotein; Polycal, Nutriciaâcarbohydrates; Calogen, Nutriciaâlipids). The intervention will continue until 37âweeks of post-conception age or hospital discharge. Parents and outcome assessors will be blinded to the intervention. The primary outcome measure is velocity of weight, length, and head growth until 36âweeks post-conceptional age or discharge. Secondary outcomes include neurodevelopment at 12âmonths assessed with Bayley Scale of Development III, repeated at 36âmonths; body composition at discharge and at 4âmonths; and incidence of necrotizing enterocolitis, sepsis, retinopathy of prematurity, and bronchopulmonary dysplasia.
Discussion
Targeted fortification has previously been shown as doable in the neonatal intensive care unit context. If it shows to improve growth and neonatal outcome, choosing the targeted fortification as a first line nutritional approach in very low birth weight infants may become a recommendation.
Trial registration
ClinicalTrials.govNCT03775785, Registered on July 2019.