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Published: 2024-01-04

A human-milk-based fortifier is not effective against severe complications

NEWS Fortification of breast milk with a very expensive product based on concentrated human milk does not improve the health of extremely preterm infants, compared to a standard fortifier. This is shown in a Swedish study of international interest, with the participation of Magnus Domellöf and other researchers at Umeå University.

Preterm infants are routinely given fortified breast milk in order to grow and develop normally. This fortifier is normally made from cow's milk, but there is a new product on the market that is made from concentrated donor breast milk.

The product (human milk based fortifier, HMBF) costs over SEK 100,000 per infant and is widely used in the United States. This is because it has been suggested to reduce serious intestinal complications (necrotizing enterocolitis, NEC) and infection (sepsis) in preterm infants.

No difference between the groups

In the absence of scientific evidence, researchers from Umeå University, together with researchers from Linköping (Thomas Abrahamsson was PI for the study), Gothenburg, Stockholm and Uppsala, conducted a randomized, controlled study of 228 extremely preterm infants, who were randomly assigned to HMBF and regular enrichment, respectively. The study is called N-forte.

"It shows that there was no difference in NEC, sepsis or death between the groups. This means that we cannot recommend this costly product for routine use. The results are of great international interest," says Magnus Domellöf, Professor of Paediatrics at the Department of Clinical Sciences, Umeå University and member of the steering committee for the N-Forte study.

Article about the study: Effect of human milk-based fortification in extremely preterm infants fed exclusively with breast milk: a randomised controlled trial, Georg Bach Jensen, Magnus Domellöf, Fredrik Ahlsson, Anders Elfvin, Lars Navér och Thomas Abrahamsson, (2023), eClinicalMedicine, publicerad online 2 januari 2024, doi: 10.1016/j.eclinm.2023.102375