OptiMoM Grows Up: 5.5-year Follow-up of the OptiMoM Fortifier Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: VLBW
Participants previously enrolled in the Bovine vs. Human Milk-Based Fortifier Study
|
| 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. |
Other: Term-born Comparison
Children born >=37 weeks gestation and weighing more than 2500g
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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).
Secondary Outcome Measures
- 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.
- 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.
- 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 (e.g., % fat mass, % fat-free mass) using air displacement plethysmography, i.e., BODPOD™.
- Body Composition [5.5 years of age]
Trained staff will measure body composition using bicep, tricep, subscapular and superilliac skinfold thicknesses.
- 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.
- 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.
- Blood pressure [5.5 years of age]
Trained staff will measure blood pressure using an automated sphygmomanometer.
Other Outcome Measures
- Affect Recognition domain [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.
- Inhibition domain [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.
- Design Fluency domain [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.
- Statue domain [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.
- Visual-Motor Integration [5.5 years of age]
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.
- Social-Emotional Functioning [5.5 years of age]
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.
- Behaviour and Emotional Response [5.5 years of age]
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.
- Executive Functioning [5.5 years of age]
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.
- Sensory Processing [5.5 years of age]
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.
- Gross Motor Development [5.5 years of age]
Measured using the assessor-administered Movement Assessment Battery for Children Second Edition (Movement ABC-2). Higher scores indicate superior performance.
- Influence of the diet on epigenetic changes [5.5 years of age]
Assessed using a buccal cell biorepository.
- Influence of genetics on taste [5.5 years of age]
Assessed using a buccal cell biorepository.
- Fatty acid status [5.5 years of age]
Assessed using a buccal cell biorepository.
- Children's eating behaviours and dietary intake [5.5 years of age]
Assessed using direct observation during a standardized lunch protocol.
- Children's eating behaviours [5.5 years of age]
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.
- Food parenting and parent dietary intake [5.5 years of age]
Assessed using direct observation during a standardized lunch protocol.
- Food parenting [5.5 years of age]
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.
- Composition and community structure of the gastrointestinal microbiota [5.5 years of age]
High-throughput sequencing of microbial DNA from stool samples
- Parent and child stress [5.5 years of age]
Measured using cortisol levels obtained from hair samples collected from both parent and child at the posterior vertex.
- Parental stress [5.5 years of age]
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.
- Home environment- Family Functioning [5.5 years of age]
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.).
- Home environment- Home Chaos [5.5 years of age]
Home Chaos will be measured by parent-report using the Confusion, Hubbub and Order Scale (CHAOS). Higher scores indicate a more chaotic home environment.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Hospital for Sick Children | Toronto | Ontario | Canada | M5G 0A4 |
Sponsors and Collaborators
- The Hospital for Sick Children
- Sinai Health System
- University of Toronto
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1000065339