OptiMoM Grows Up: 5.5-year Follow-up of the OptiMoM Fortifier 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 infants born VLBW who were fed mother's own milk or pasteurized donor breastmilk nutrient enriched with a human milk-based fortifier or a bovine protein-based fortifier. Intakes of donor milk, fortifier type, macronutrients and fatty acids will be explored. Areas of development to be assessed include: cognition, language, motor skills, and body composition. This study will also cross-sectionally examine aspects of eating behaviours, food parenting and the home environment (e.g., stress, home chaos, family functioning) with a term-born comparison. A DNA biorepository will also be created.

Official Title
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OptiMoM Grows Up: 5.5-year Follow-up of the OptiMoM Fortifier Study

Conditions
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Infant, Very Low Birth Weight

Intervention / Treatment
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* Other: VLBW
* Other: Term-born Comparison


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children who were enrolled in the Bovine vs. Human Milk-Based Fortifier Study (NCT02137473) Children who were born >=37 weeks gestation and weighing > 2500g [Term-born comparison group] Exclusion Criteria: For term-born comparison only: a child with any chromosomal or congenital anomaly affecting growth

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

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 enrolled in the OptiMoM Fortifier Study<br>This is an observational study of children who were previously enrolled in a trial (Bovine vs. Human Milk-Based Fortifier Study) between 2014 and 2016 during which time they were randomized to have their feeds (mother's own milk or pasteurized donor breastmilk) nutrient enriched with a human milk-based fortifier or a bovine protein-based fortifier. | Other: VLBW<br>* Participants previously enrolled in the Bovine vs. Human Milk-Based Fortifier Study<br>|
| Term-born Comparison<br>This is an observational study of children born at full term (>= 37 weeks gestation) and weighing more than 2500g. These children will be recruited from the communities in which the OptiMoM participants live. | Other: Term-born Comparison<br>* Children born >=37 weeks gestation and weighing more than 2500g<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full-Scale Intelligence Quotient (IQ) | Measured using the assessor-administered Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV). The WPPSI-IV Full-scale IQ and all composite sub-scales are standardized to a mean of 100, with a standard deviation of 15. Higher scores indicate superior performance. | 5.5 years of age | 
| Growth | Growth as assessed by weight in kilograms (kg) and height in meters (m) measured by trained staff to assess body mass index (BMI). BMI will be the ratio of weight (kg) to the square of height (m). | 5.5 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal Comprehension Index | Measured using the assessor-administered Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV). The WPPSI-IV composite sub-scales are standardized to a mean of 100, with a standard deviation of 15. Higher scores indicate superior performance. | 5.5 years of age | 
| Visual Spatial Index | Measured using the assessor-administered Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV). The WPPSI-IV composite sub-scales are standardized to a mean of 100, with a standard deviation of 15. Higher scores indicate superior performance. | 5.5 years of age | 
| Working Memory Index | Measured using the assessor-administered Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV). The WPPSI-IV composite sub-scales are standardized to a mean of 100, with a standard deviation of 15. Higher scores indicate superior performance. | 5.5 years of age | 
| Fluid Reasoning Index | Measured using the assessor-administered Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV). The WPPSI-IV composite sub-scales are standardized to a mean of 100, with a standard deviation of 15. Higher scores indicate superior performance. | 5.5 years of age | 
| Vocabulary Acquisition Index | Measured using the assessor-administered Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV). The WPPSI-IV composite sub-scales are standardized to a mean of 100, with a standard deviation of 15. Higher scores indicate superior performance. | 5.5 years of age | 
| Processing Speed Index | Measured using the assessor-administered Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV). The WPPSI-IV composite sub-scales are standardized to a mean of 100, with a standard deviation of 15. Higher scores indicate superior performance. | 5.5 years of age | 
| Body Composition | Trained staff will measure body composition (e.g., % fat mass, % fat-free mass) using air displacement plethysmography, i.e., BODPOD™. | 5.5 years of age | 
| Body Composition | Trained staff will measure body composition using bicep, tricep, subscapular and superilliac skinfold thicknesses. | 5.5 years of age | 
| Diet Quality | Diet Quality as measured using the Healthy Eating Index calculated from two 24-hour recalls conducted by trained staff. Scores on the Healthy Eating Index range from 0-100 with higher scores indicated higher diet quality. | 5.5 years of age | 
| Waist circumference | Trained staff will measure waist circumference (cm) at the midpoint between the top of the iliac crest and lowest rib. | 5.5 years of age | 
| Blood pressure | Trained staff will measure blood pressure using an automated sphygmomanometer. | 5.5 years of age |