Clinical trial NCT02759809: OptiMoM Kindergarten Study
Official title: Optimizing Mothers' Milk for Preterm Infants (OptiMoM) Program of Research: Study 1-Impact of Donor Milk at Kindergarten
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Very Low Birth Weight
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 158
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Very low birth weight infants previously enrolled in the DoMINO (Donor Milk for Improved Neurodevelopmental Outcomes) trial (ISRCTN35317141).

Brief summary: In Canada, the leading cause of long-term disability in children is being born at very low birth weight (VLBW). To help improve outcomes, nutrition is a modifiable aspect of infant care. Mother's milk is the optimal way to feed VLBW infants; however, many need a supplement of donor milk or preterm formula as not enough mother's milk is available. As the ideal supplement for prolonged feeding and its long-term effects is currently unknown, this study is a prospective follow up of VLBW infants who in hospital were fed: donor milk or preterm formula and/or mother's milk. Areas of development to be assessed include: cognition, language, motor skills, brain structure/function, and body composition. A DNA biorepository will also be created.


Eligibility criteria: Inclusion Criteria:

* Children who were enrolled in the DoMINO (Donor Milk for Improved Neurodevelopmental Outcomes) trial (ISRCTN35317141).

Primary outcomes:
measure: Full-Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV)
timeFrame: 5.5 years of age
Secondary outcomes:
measure: Verbal IQ on the WPPSI-IV
timeFrame: 5.5 years of age
measure: Performance IQ on the WPPSI-IV
timeFrame: 5.5 years of age
measure: General Language Composite on the WPPSI-IV
timeFrame: 5.5 years of age
measure: Processing Speed Quotient on the WPPSI-IV
timeFrame: 5.5 years of age
measure: Growth
timeFrame: 5.5 years of age
measure: Body Composition
timeFrame: 5.5 years of age
Other outcomes:
measure: Affect Recognition domain on the NEPSY-II
timeFrame: 5.5 years of age
measure: Language domain on the NEPSY-II
timeFrame: 5.5 years of age
measure: Memory domain on the NEPSY-II
timeFrame: 5.5 years of age
measure: Visual-Motor Integration using the Beery
timeFrame: 5.5 years of age
measure: Development of Brain Structure
timeFrame: 5.5 years of age
measure: Development of Brain Function
timeFrame: 5.5 years of age
measure: Interaction of genetic differences and feeding type on outcomes
timeFrame: 5.5 years of age
measure: Influence of the diet on epigenetic changes
timeFrame: 5.5 years of age
measure: School Readiness using the Early Development Instrument (EDI)
timeFrame: 5.5 years of age
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
citation: Xu J, Shin J, McGee M, Unger S, Bando N, Sato J, Vandewouw M, Patel Y, Branson HM, Paus T, Pausova Z, O'Connor DL. Intake of mother's milk by very-low-birth-weight infants and variation in DNA methylation of genes involved in neurodevelopment at 5.5 years of age. Am J Clin Nutr. 2022 Oct 6;116(4):1038-1048. doi: 10.1093/ajcn/nqac221.
citation: Walton K, McGee M, Sato J, Law N, Hopperton KE, Bando N, Kiss A, Unger SL, O'Connor DL. Social-emotional functioning and dietary intake among children born with a very low birth weight. Appl Physiol Nutr Metab. 2022 Jul 1;47(7):737-748. doi: 10.1139/apnm-2021-0434. Epub 2022 Feb 23.
citation: McGee M, Unger S, Hamilton J, Birken CS, Pausova Z, Kiss A, Bando N, O'Connor DL. Associations between Diet Quality and Body Composition in Young Children Born with Very Low Body Weight. J Nutr. 2020 Nov 19;150(11):2961-2968. doi: 10.1093/jn/nxaa281.
citation: McGee M, Unger S, Hamilton J, Birken CS, Pausova Z, Kiss A, Bando N, O'Connor DL. Adiposity and Fat-Free Mass of Children Born with Very Low Birth Weight Do Not Differ in Children Fed Supplemental Donor Milk Compared with Those Fed Preterm Formula. J Nutr. 2020 Feb 1;150(2):331-339. doi: 10.1093/jn/nxz234.