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DoMINO: Donor milk for improved neurodevelopmental outcomes.
BMC Pediatr. 2014 May 13; 14:123.BPed

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, 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.

Authors+Show Affiliations

No affiliation info availableNo affiliation info availableNo affiliation info availableUniversity of Toronto and The Hospital for Sick Children, 327 Fitzgerald Building, 150 College Street, Toronto, Ontario, M5S 3E2, Canada. deborah.oconnor@utoronto.ca.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

24884424

Citation

Unger, Sharon, et al. "DoMINO: Donor Milk for Improved Neurodevelopmental Outcomes." BMC Pediatrics, vol. 14, 2014, p. 123.
Unger S, Gibbins S, Zupancic J, et al. DoMINO: Donor milk for improved neurodevelopmental outcomes. BMC Pediatr. 2014;14:123.
Unger, S., Gibbins, S., Zupancic, J., & O'Connor, D. L. (2014). DoMINO: Donor milk for improved neurodevelopmental outcomes. BMC Pediatrics, 14, 123. https://doi.org/10.1186/1471-2431-14-123
Unger S, et al. DoMINO: Donor Milk for Improved Neurodevelopmental Outcomes. BMC Pediatr. 2014 May 13;14:123. PubMed PMID: 24884424.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - DoMINO: Donor milk for improved neurodevelopmental outcomes. AU - Unger,Sharon, AU - Gibbins,Sharyn, AU - Zupancic,John, AU - O'Connor,Deborah L, Y1 - 2014/05/13/ PY - 2014/02/23/received PY - 2014/05/01/accepted PY - 2014/6/3/entrez PY - 2014/6/3/pubmed PY - 2015/1/23/medline SP - 123 EP - 123 JF - BMC pediatrics JO - BMC Pediatr VL - 14 N2 - 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. SN - 1471-2431 UR - https://www.unboundmedicine.com/medline/citation/24884424/DoMINO:_Donor_milk_for_improved_neurodevelopmental_outcomes_ L2 - https://bmcpediatr.biomedcentral.com/articles/10.1186/1471-2431-14-123 DB - PRIME DP - Unbound Medicine ER -