How can breast milk components prevent necrotizing enterocolitis and sepsis in extremely preterm infants?

Background: Although the care of premature infants has improved dramatically during the last decades, extremly preterm infants (born before gestational week 28+0) remain a major challenge for neonatal intensive care.  20% of these babies die and the survivors often have a complicated clinical course with major morbidity and a significant risk of poor neurological outcome.

Severe infections and necrotizing enterocolitis (NEC) are common causes of death.Purpose and aim: To explore how breast milk composition influences the development of sepsis and NEC in extremely preterm infant in order to improve clinical guidelines and identify future treatments in this  patient group.Project design and organisation: A randomised-controlled multi-centre trial in 24 neonatal units will be conducted in collaboration between researchers from 6 out of 7 university units in Sweden.

In total 316 extremely preterm infants will be randomised to get breast milk fortified by either human milk-based or cow´s milk-based fortifier. Primary outcome is NEC and sepsis.

Moreover, human milk oligosacharides will be analysed in breast milk, immune cells in blood and microbiome and metabolomics in stool samples to identifying future targets for treatment. The clinical trial started in 2019 and will be completed in 2022. Lab analyses will go on 2022-2023.

Relevance:  A significant effect human-milk-based fortfifier could easily be implemented and have a dramatic impact on the well-being of these patients.