‘Exclusive human milk diet’ – new research regarding fortification options for breast milk

Premature babies routinely receive protein-enriched breast milk in order to grow and develop normally. This fortification is normally made from cow’s milk but there is a new fortification product on the market that is made from concentrated donated breast milk.

This product (human milk-based fortifier, HMBF) is very expensive (costing >100,000 SEK per child) but is widely used in the USA and also some European countries as it has been suggested to be able to reduce serious intestinal complication (necrotizing enterocolitis, NEC) and infection (sepsis) in preterm infants.

Since there was a lack of scientific evidence, researchers from Umeå University, together with researchers from Linköping, Gothenburg, Stockholm and Uppsala, have conducted a randomized, controlled study of 228 extremely premature babies who were randomly assigned to HMBF or regular fortification.

Results from the study ‘Nordic Study on Human Milk Fortification in Extremely Preterm Infants: a Randomized Controlled Trial’, is now available as a preprint at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4529245.

The trial shows that in extremely preterm infants exclusively fed human milk, supplementation with HMBF did not affect mortality or severe morbidity. The results of this multicentre trial do not support routine supplementation with HMBF as a nutritional strategy to prevent death, NEC, or sepsis in extremely preterm infants receiving enteral feeding with only mother’s own milk or donor breast milk.

The trial’s investigators highlight that to the best of their knowledge, this is the largest prospective randomised controlled trial evaluating HMBF in infants with a base diet of exclusive breast milk, and the first with statistical power to evaluate severe outcomes in preterm infants.

“The results from this study is of great international interest and will help guide treatment choices for this vulnerable patient group. We have already received a lot of attention from the scientific community online” says Prof Domellöf.