tailieunhanh - DoMINO: Donor milk for improved neurodevelopmental outcomes

Provision of mother’s own milk is the optimal way to feed infants, including very low birth weight infants (VLBW, | Unger et al. BMC Pediatrics 2014 14 123 http 1471-2431 14 123 BMC Pediatrics STUDY PROTOCOL Open Access DoMINO Donor milk for improved neurodevelopmental outcomes c h I I Z r J r1 c h r K I r i I I c2 I V h 71 I s vx z ỉ 3 vx 1 CA k sz I I if r M 4 Sharon Unger Sharyn Glooms John zupancic ano Deborah L OConnor Abstract Background Provision of mother s own milk is the optimal way to feed infants including very low birth weight infants VLBW 1500 g . Importantly for VLBW infants who are at elevated risk of neurologic sequelae mother s own milk has been shown to enhance neurocognitive development. Unfortunately the majority of mothers of VLBW infants are unable to provide an adequate supply of milk and thus supplementation with formula or donor milk is necessary. Given the association between mother s own milk and neurodevelopment it is important to ascertain whether provision of human donor milk as a supplement may yield superior neurodevelopmental outcomes compared to formula. Our primary hypothesis is that VLBW infants fed pasteurized donor milk compared to preterm formula as a supplement to mother s own milk for 90 days or until hospital discharge whichever comes first will have an improved cognitive outcome as measured at 18 months corrected age on the Bayley Scales of Infant Development 3rd ed. Secondary hypotheses are that the use of pasteurized donor milk will 1 reduce a composite of death and serious morbidity 2 support growth and 3 improve language and motor development. Exploratory research questions include Will use of pasteurized donor milk 1 influence feeding tolerance and nutrient intake 2 have an acceptable cost effectiveness from a comprehensive societal perspective Methods Design DoMINO is a multi-centre intent-to-treat double blinded randomized control trial. VLBW infants n 363 were randomized within four days of birth to either 1 pasteurized donor milk or 2 preterm formula whenever mother s own milk was unavailable. Study .

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