DoMINO: Donor milk for improved neurodevelopmental outcomes

BMC Pediatrics

Deborah L O’Connor³  John Zupancic²  Sharyn Gibbins¹  Sharon Unger⁴ 

[1] Trillium Health Partners, 2200 Eglinton Ave West, Mississauga, Ontario, L5M 2 N1, Canada;Beth Israel Deaconess Med Center, Neonatology, Rose 318 330 Brookline Ave, Boston, MA 02215, USA;University of Toronto and The Hospital for Sick Children, 327 Fitzgerald Building, 150 College Street, Toronto, Ontario, M5S 3E2, Canada;Mount Sinai Hospital and the University of Toronto, 600 University Avenue, 19-231, Toronto, Ontario, M5G 1X5, Canada

关键词: Very low birth weight infants;    Neurodevelopment;    Donor milk;    Human milk;   

Others  :  1138861
DOI  :  10.1186/1471-2431-14-123

 received in 2014-02-23, accepted in 2014-05-01,  发布年份 2014

【 摘 要 】

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, 3^rd 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 recruitment began in October 2010 and was completed in December 2012. The 90 day feeding intervention is complete and long-term follow-up is underway.

Discussion

Preterm birth and its complications are a leading cause long-term morbidity among Canadian children. Strategies to mitigate this risk are urgently required. As mother’s own milk has been shown to improve neurodevelopment, it is essential to ascertain whether pasteurized donor milk will confer the same advantage over formula without undue risks and at acceptable costs. Knowledge translation from this trial will be pivotal in setting donor milk policy in Canada and beyond.

Trial registration

ISRCTN35317141; Registered 10 August 2010.

【 授权许可】

   
2014 Unger et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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