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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children previously assigned to donor milk in the DoMINO trial | This study is an observational study of children who were enrolled in a previous trial (DoMINO trial) between 2010 and 2012 during which they were randomized to receive donor milk when mother's own breastmilk was unavailable. Donor milk was from a milk bank part of the Human Milk Banking Association of North America (HMBANA). |
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| Children previously assigned to formula in the DoMINO trial | This study is an observational study of children who were enrolled in a previous trial (DoMINO trial) between 2010 and 2012 during which they were randomized to receive preterm formula when mother's own breastmilk was unavailable. Preterm formula was either Similac Special Care or Enfamil Premature depending on hospital contract with formula companies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pasteurized donor human breastmilk | Other |
| ||
| Preterm formula |
| Measure | Description | Time Frame |
|---|---|---|
| Full-Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV) | 5.5 years of age |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal IQ on the WPPSI-IV | 5.5 years of age | |
| Performance IQ on the WPPSI-IV | 5.5 years of age | |
| General Language Composite on the WPPSI-IV |
| Measure | Description | Time Frame |
|---|---|---|
| Affect Recognition domain on the NEPSY-II | 5.5 years of age | |
| Language domain on the NEPSY-II | 5.5 years of age | |
| Memory domain on the NEPSY-II |
Inclusion Criteria:
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Very low birth weight infants previously enrolled in the DoMINO (Donor Milk for Improved Neurodevelopmental Outcomes) trial (ISRCTN35317141).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35977396 | Derived | 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. | |
| 35196153 |
| Label | URL |
|---|---|
| Donor Milk for Improved Neurodevelopmental Outcomes (DoMINO) trial | View source |
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| Other |
|
| 5.5 years of age |
| Processing Speed Quotient on the WPPSI-IV | 5.5 years of age |
| Growth | Growth as assessed using weight, height and waist circumference measurements. | 5.5 years of age |
| Body Composition | Body composition as assessed using the COSMED BOD POD and skinfold thickness. | 5.5 years of age |
| 5.5 years of age |
| Visual-Motor Integration using the Beery | 5.5 years of age |
| Development of Brain Structure | Development of brain structure as assessed using Magnetic Resonance Imaging (MRI). | 5.5 years of age |
| Development of Brain Function | Development of brain function as assessed using Magnetoencephalography (MEG). | 5.5 years of age |
| Interaction of genetic differences and feeding type on outcomes | Assessed using a buccal cell biorepository. | 5.5 years of age |
| Influence of the diet on epigenetic changes | Assessed using a buccal cell biorepository. | 5.5 years of age |
| School Readiness using the Early Development Instrument (EDI) | 5.5 years of age |
| 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. |
| 33025010 | Derived | 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. |
| 31599955 | Derived | 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. |