An observational study in Infant, Very Low Birth Weight, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 5 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by The Hospital for Sick Children · Observational
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.
445 studies on the registry are indexed under Birth Weight; 36 are open to participants now.
This study's enrollment of 149 is below the median of 212 across 136 observational studies indexed under Birth Weight.
Browse Birth Weight studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
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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.
Exclusion Criteria:
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
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
Participants previously enrolled in the Bovine vs. Human Milk-Based Fortifier Study
Children born \>=37 weeks gestation and weighing more than 2500g
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.
Time frame: 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).
Time frame: 5.5 years of age
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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™.
Time frame: 5.5 years of age
Body Composition
Trained staff will measure body composition using bicep, tricep, subscapular and superilliac skinfold thicknesses.
Time frame: 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.
Time frame: 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.
Time frame: 5.5 years of age
Blood pressure
Trained staff will measure blood pressure using an automated sphygmomanometer.
Time frame: 5.5 years of age
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.
Time frame: 5.5 years of age
Inhibition 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5.5 years of age
Influence of the diet on epigenetic changes
Assessed using a buccal cell biorepository.
Time frame: 5.5 years of age
Influence of genetics on taste
Assessed using a buccal cell biorepository.
Time frame: 5.5 years of age
Fatty acid status
Assessed using a buccal cell biorepository.
Time frame: 5.5 years of age
Children's eating behaviours and dietary intake
Assessed using direct observation during a standardized lunch protocol.
Time frame: 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.
Time frame: 5.5 years of age
Food parenting and parent dietary intake
Assessed using direct observation during a standardized lunch protocol.
Time frame: 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.
Time frame: 5.5 years of age
Composition and community structure of the gastrointestinal microbiota
High-throughput sequencing of microbial DNA from stool samples
Time frame: 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.
Time frame: 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.
Time frame: 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.).
Time frame: 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.
Time frame: 5.5 years of age
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children