Ontology highlight
ABSTRACT: Background
Bovine 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.Objective
To compare neurodevelopment in infants born weighing <1250 g fed maternal milk with supplemental donor milk and either a HMBF or BMBF.Methods
This 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 (n = 64) or BMBF (n = 63) added to maternal milk with supplemental donor milk during hospitalization. Neurodevelopment was assessed at 18-mo corrected age using the Bayley Scales of Infant and Toddler Development, Third Edition. Follow-up was completed in October 2017.Results
Of 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.Conclusions
Providing 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.
SUBMITTER: Hopperton KE
PROVIDER: S-EPMC7053578 | biostudies-literature | 2019 Dec
REPOSITORIES: biostudies-literature
Hopperton Kathryn E KE O'Connor Deborah L DL Bando Nicole N Conway Aisling M AM Ng Dawn V Y DVY Kiss Alex A Jackson Jacqueline J Ly Linh L Unger Sharon L SL
Current developments in nutrition 20191112 12
<h4>Background</h4>Bovine 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.<h4>Objective</h4>To compare neurodevelopment in infants born weighing <1250 g fed maternal milk ...[more]