OptiMoM Kindergarten Study

Study Overview
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Brief Summary
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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.

Official Title
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Optimizing Mothers' Milk for Preterm Infants (OptiMoM) Program of Research: Study 1-Impact of Donor Milk at Kindergarten

Conditions
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Infant, Very Low Birth Weight

Intervention / Treatment
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* Other: Pasteurized donor human breastmilk
* Other: Preterm formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children who were enrolled in the DoMINO (Donor Milk for Improved Neurodevelopmental Outcomes) trial (ISRCTN35317141).

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children previously assigned to donor milk in the DoMINO trial<br>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). | Other: Pasteurized donor human breastmilk<br> <br> |
| Children previously assigned to formula in the DoMINO trial<br>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. | Other: Preterm formula<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full-Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV) |  | 5.5 years of age | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |