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Nordic study on human milk fortification in extremely preterm infants: a randomised controlled trial-the N-forte

Georg Bach Jensen1,2, Fredrik Ahlsson3, Magnus Domellöf4

  • 1Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.

BMJ Open
|November 24, 2021
PubMed

Insights

Supplementing human milk with human milk-based fortifier may reduce necrotizing enterocolitis (NEC), sepsis, and mortality in extremely low gestational age (ELGA) infants. This study compares human milk-based versus bovine-based fortifiers in ELGA infants exclusively fed human milk.

Area of Science:

  • Neonatal nutrition
  • Pediatric gastroenterology
  • Clinical trial methodology

Background:

  • Extremely low gestational age (ELGA) infants face high mortality, with sepsis and necrotizing enterocolitis (NEC) as primary causes.
  • Human milk reduces sepsis and NEC risk in preterm infants compared to bovine milk formula.
  • ELGA infants fed human milk often receive cow's milk protein from bovine-based fortifiers, potentially negating human milk benefits.

Purpose of the Study:

  • To evaluate if a human milk-based nutrient fortifier reduces NEC, sepsis, and mortality in ELGA infants.
  • To compare the outcomes of ELGA infants receiving human milk supplemented with human milk-based fortifier versus bovine-based fortifier.
  • To investigate the impact of different fortifiers on the health and development of ELGA infants.

Main Methods:

  • A randomized-controlled multicenter trial involving 222-322 ELGA infants exclusively fed human milk.
  • Infants randomized to either human milk-based or bovine-based fortifier supplementation.
  • Primary outcome: composite of NEC, sepsis, or death. Secondary outcomes include clinical data, nutritional status, and long-term neurodevelopmental and growth follow-up.

Main Results:

  • The study is ongoing, and results are pending.
  • Comprehensive clinical, nutritional, and biological data are being collected.
  • Long-term follow-up for neurological development and growth is planned.

Conclusions:

  • The study aims to determine the optimal nutritional strategy for ELGA infants to improve survival and reduce morbidities.
  • Findings will inform clinical practice regarding the use of human milk fortifiers in extremely preterm infants.
  • This research addresses a critical gap in understanding the benefits of human milk-based fortifiers in a vulnerable population.
Abstract

Keywords:
developmental neurology & neurodisabilityneonatal intensive & critical careneonatologynutrition & dietetics

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