Nutrient Enrichment of Human Milk with Human and Bovine Milk-Based Fortifiers for Infants Born <1250 g: 18-Month Neurodevelopment Follow-Up of a Randomized Clinical Trial.

backgroundBovine milk-based fortifiers (BMBF) have been standard of care for nutrient fortification of feeds for very low birth weight (VLBW) infants, however, there is increasing use of human milk-based fortifiers (HMBF) in neonatal care despite additional costs and limited supporting data. No randomized clinical trial has followed infants fed these fortifiers after initial hospitalization.

objectiveTo compare neurodevelopment in infants born weighing <1250 g fed maternal milk with supplemental donor milk and either a HMBF or BMBF.

methodsThis is a follow-up of a completed pragmatic, triple-blind, parallel group randomized clinical trial conducted in Southern Ontario between August 2014 and March 2016 (NCT02137473) with feeding tolerance as the primary outcome. Infants weighing <1250 g at birth were block randomized by an online third-party service to receive either HMBF (

resultsOf the 127 infants randomized, 109 returned for neurodevelopmental assessment. No statistically significant differences between fortifiers were identified for cognitive composite scores [adjusted mean scores 94.7 in the HMBF group and 95.9 in the BMBF group; fully adjusted mean difference, -1.1 (95% CI: -6.5 to 4.4)], language composite scores [adjusted scores 92.4 in the HMBF group and 93.1 in the BMBF; fully adjusted mean difference, -1.2 (-7.5 to 5.1)], or motor composite scores [adjusted scores 95.6 in the HMBF group and 97.7 in the BMBF; fully adjusted mean difference, -1.1 (-6.3 to 4.2)]. There was no difference in the proportion of participants that died or had neurodevelopmental impairment or disability between groups.

conclusionsProviding HMBF compared with BMBF does not improve neurodevelopmental scores at 18-mo corrected age in infants born <1250 g otherwise fed a human milk diet. This trial was registered at clinicaltrials.gov as NCT02137473.