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| Name | Class |
|---|---|
| Sinai Health System | OTHER |
| University of Toronto | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children previously enrolled in the OptiMoM Fortifier Study | 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. |
| |
| Term-born Comparison | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VLBW | Other | Participants previously enrolled in the Bovine vs. Human Milk-Based Fortifier Study |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Affect Recognition domain | Measured using the assessor-administered Developmental Neuropsychological Assessment-Second Edition (NEPSY-II). Scaled scores for each subtest consist of a mean of 10 and a standard deviation of 3 (range of 1-19). Higher scores indicate superior performance. | 5.5 years of age |
| Inhibition domain |
Inclusion Criteria:
Exclusion Criteria:
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Very low birth weight infants previously enrolled in the Bovine vs. Human Milk-Based Fortifier Study (NCT02137473) and a comparison group of children born full-term (>=37 weeks gestation) and weighing >2500g.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 0A4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41072552 | Derived | Walton K, Hopperton KE, Lambis A, Law N, Vaz S, Kiss A, Unger SL, O'Connor DL. Caregiver feeding practices, dietary intake and weight status of very low birthweight infants compared to term-born peers at school-entry. Appetite. 2026 Feb 1;217:108338. doi: 10.1016/j.appet.2025.108338. Epub 2025 Oct 8. |
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| Term-born Comparison | Other | Children born >=37 weeks gestation and weighing more than 2500g |
|
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 |
Measured using the assessor-administered Developmental Neuropsychological Assessment-Second Edition (NEPSY-II). Scaled scores for each subtest consist of a mean of 10 and a standard deviation of 3 (range of 1-19). Higher scores indicate superior performance. |
| 5.5 years of age |
| Design Fluency domain | Measured using the assessor-administered Developmental Neuropsychological Assessment-Second Edition (NEPSY-II). Scaled scores for each subtest consist of a mean of 10 and a standard deviation of 3 (range of 1-19). Higher scores indicate superior performance. | 5.5 years of age |
| Statue domain | Measured using the assessor-administered Developmental Neuropsychological Assessment-Second Edition (NEPSY-II). Scaled scores for each subtest consist of a mean of 10 and a standard deviation of 3 (range of 1-19). Higher scores indicate superior performance. | 5.5 years of age |
| Visual-Motor Integration | Measured using the assessor-administered Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI). Standard scores with a mean of 100 and a standard deviation of 15 will be reported. Higher scores on the Beery VMI indicate superior performance. | 5.5 years of age |
| Social-Emotional Functioning | Social-Emotional functioning as measured by parent-report using the Social Responsiveness Scale Second Edition (SRS-2). T-scores on the SRS-2 have a mean of 50 and standard deviation of 10. Higher scores are associated with more severe social impairments. | 5.5 years of age |
| Behaviour and Emotional Response | Behaviour and Emotional Response as measured by parent-report using the Behavior Assessment System for Children-Third Edition (BASC-3). Scores are expressed as T-scores with a mean of 50 and standard deviation of 10. Higher values indicate increased risk for composites of clinical scales and lower risk for the composite of adaptive scales. | 5.5 years of age |
| Executive Functioning | Executive Functioning as measured by parent-report using the Behavioral Rating Inventory of Executive Function (BRIEF). T-scores have a mean of 50 and a standard deviation of 10. Higher scores indicate a potential problematic area of clinical significance. | 5.5 years of age |
| Sensory Processing | Sensory Processing related to auditory, visual, touch, movement, body position and oral processing as measured by parent-report using the Sensory Profile Second Edition (Sensory Profile-2). Higher scores indicating higher sensitivity in each category. | 5.5 years of age |
| Gross Motor Development | Measured using the assessor-administered Movement Assessment Battery for Children Second Edition (Movement ABC-2). Higher scores indicate superior performance. | 5.5 years of age |
| Influence of the diet on epigenetic changes | Assessed using a buccal cell biorepository. | 5.5 years of age |
| Influence of genetics on taste | Assessed using a buccal cell biorepository. | 5.5 years of age |
| Fatty acid status | Assessed using a buccal cell biorepository. | 5.5 years of age |
| Children's eating behaviours and dietary intake | Assessed using direct observation during a standardized lunch protocol. | 5.5 years of age |
| Children's eating behaviours | Assessed by parent-report using the Child Eating Behaviour Questionnaire (CEBQ). The CEBQ is made up of eight scales: Food responsiveness, Emotional over-eating, Enjoyment of food, Desire to drink, Satiety responsiveness, Slowness in eating, Emotional under-eating, and Food fussiness. Higher scores indicate higher frequency behaviour. | 5.5 years of age |
| Food parenting and parent dietary intake | Assessed using direct observation during a standardized lunch protocol. | 5.5 years of age |
| Food parenting | Assessed by parent-report using the Comprehensive Feeding Practices Questionnaire (CFPQ). The questionnaire contains 12 scales: 'Encourage Balance and Variety', 'Environment', 'Involvement', 'Modeling', 'Monitoring', 'Teaching about Nutrition', 'Emotion Regulation', 'Food as Reward', 'Pressure', 'Child Control', 'Restriction for Health' and 'Restriction for Weight Control'; higher scores indicate higher frequency behaviour. | 5.5 years of age |
| Composition and community structure of the gastrointestinal microbiota | High-throughput sequencing of microbial DNA from stool samples | 5.5 years of age |
| Parent and child stress | Measured using cortisol levels obtained from hair samples collected from both parent and child at the posterior vertex. | 5.5 years of age |
| Parental stress | Measured by parent-report using the Parent Distress sub-scale of the Parenting Stress Index Short Form (PSI-SF). Higher scores indicate higher levels of parental distress. | 5.5 years of age |
| Home environment- Family Functioning | Family functioning will be measured by parent-report using the General Functioning sub-scale of the Family Assessment Device (FAD). Higher scores indicate lower levels of functioning (problem solving, communication, etc.). | 5.5 years of age |
| Home environment- Home Chaos | Home Chaos will be measured by parent-report using the Confusion, Hubbub and Order Scale (CHAOS). Higher scores indicate a more chaotic home environment. | 5.5 years of age |