OptiMoM Grows Up: 5.5-year Follow-up of the OptiMoM Fortifier Study
- Conditions
- Infant, Very Low Birth Weight
- Interventions
- Other: VLBWOther: Term-born Comparison
- Registration Number
- NCT04308902
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
- 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]
- For term-born comparison only: a child with any chromosomal or congenital anomaly affecting growth
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Children previously enrolled in the OptiMoM Fortifier Study VLBW 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 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.
- Primary Outcome Measures
Name Time Method Growth 5.5 years of age 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).
Full-Scale Intelligence Quotient (IQ) 5.5 years of age 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.
- Secondary Outcome Measures
Name Time Method Diet Quality 5.5 years of age 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.
Working Memory Index 5.5 years of age 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.
Fluid Reasoning Index 5.5 years of age 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.
Vocabulary Acquisition Index 5.5 years of age 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.
Blood pressure 5.5 years of age Trained staff will measure blood pressure using an automated sphygmomanometer.
Processing Speed Index 5.5 years of age 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.
Body Composition 5.5 years of age Trained staff will measure body composition using bicep, tricep, subscapular and superilliac skinfold thicknesses.
Waist circumference 5.5 years of age Trained staff will measure waist circumference (cm) at the midpoint between the top of the iliac crest and lowest rib.
Verbal Comprehension Index 5.5 years of age 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.
Visual Spatial Index 5.5 years of age 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.
Trial Locations
- Locations (1)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada