Effect of Supplemental Donor Human Milk Compared With Preterm Formula on Neurodevelopment of Very Low-Birth-Weight Infants at 18 Months

Abstract

IMPORTANCE For many very low-birth-weight (VLBW) infants, there is insufficient mother's milk, and a supplement of pasteurized donor human milk or preterm formula is required. Awareness of the benefits of mother's milk has led to an increase in use of donor milk, despite limited data evaluating its efficacy.OBJECTIVE To determine if nutrient-enriched donor milk compared with formula, as a supplement to mother's milk, reduces neonatal morbidity, supports growth, and improves neurodevelopment in VLBW infants. DESIGN, SETTING, AND PARTICIPANTSIn this pragmatic, double-blind, randomized trial, VLBW infants were recruited from 4 neonatal units in Ontario, Canada, within 96 hours of birth between October 2010 and December 2012. Follow-up was completed in July 2015.INTERVENTIONS Infants were fed either donor milk or formula for 90 days or to discharge when mother's milk was unavailable. MAIN OUTCOMES AND MEASURESThe primary outcome was the cognitive composite score on the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) at 18 months' corrected age (standardized mean, 100 [SD,15]; minimal clinically important difference, 5 points). Secondary outcomes included Bayley-III language and motor composite scores, growth, and a dichotomous mortality and morbidity index. RESULTSOf 840 eligible infants, 363 (43.2%) were randomized (181 to donor milk and 182 to preterm formula); of survivors, 299 (92%) had neurodevelopment assessed. Mean birth weight and gestational age of infants was 996 (SD, 272) g and 27.7 (2.6) weeks, respectively, and 195 (53.7%) were male. No statistically significant differences in mean Bayley-III cognitive composite score (adjusted scores, 92.9 in donor milk group vs 94.5 in formula group; fully adjusted mean difference, −2.0 [95% CI, −5.8 to 1.8]), language composite score (adjusted scores, 87.3 in donor milk group vs 90.3 in formula group; fully adjusted mean difference, −3.1 [95% CI, −7.5 to 1.3]), or motor composite score (adjusted scores, 91.8 in donor milk group vs 94.0 in formula group; fully adjusted mean difference, −3.7 [95% CI, −7.4 to 0.09]) were observed between groups. There was no statistically significant difference in infants positive for the mortality and morbidity index (43% in donor milk group, 40% in formula group) or changes in growth z scores.CONCLUSIONS AND RELEVANCE Among VLBW infants, use of supplemental donor milk compared with formula did not improve neurodevelopment at 18 months' corrected age. If donor milk is used in settings with high provision of mother's milk, this outcome should not be considered a treatment goal.

Immunonutrition for Preterm Infants

“…Further evidence for the immunoprotective benefits of human milk comes from meta-analyses of randomised controlled trials that assessed the effect of donor human breast milk versus formula for feeding preterm infants [14]. Despite the potential for donor milk processing, including freeze-thaw cycles and pasteurisation, to reduce levels of its bioactive components, recent high-quality trial data have confirmed that feeding very preterm infants with donor breast milk versus formula reduces the risk of NEC [15]. Some concerns remain about the nutritional sufficiency of donor breast milk, but this can be compensated by addition of multi-nutrient fortifiers extracted from cow’s milk [16].…”

The direct and indirect influence of own mother’s milk on bronchopulmonary dysplasia and costs

“…In this cohort, there was no difference in the incidence of BPD between infants who received human milk and those who did not, but the investigators did not evaluate a dose dependent relationship for this morbidity. Similarly, in the recent Canadian randomised trial of donor human milk versus preterm formula as a supplement to mother’s own milk, O’Connor and colleagues8 found no significant difference in the number of infants receiving supplemental oxygen at 36 weeks PMA, although it is important to note that infants in both groups received a substantial proportion of maternal milk in this study. The report by Patel does not address the question of the impact of donor human milk on BPD.…”

Beneficios a Corto, Medio Y Largo Plazo De La Ingesta De Leche Humana en Recien Nacidos De Muy Bajo Peso

“…A diferencia de otros artículos (14), nosotros encontramos mayor peso a los dos años en los niños alimentados con lactancia materna exclusiva. Es conocido el superior valor nutricional de la leche de la propia madre comparada con la leche donada, dado que esta suele proceder de madres que han dado a luz niños a término y con lactancia establecida.…”