Clinical trial NCT04308902: OptiMoM Grows Up: 5.5-year Follow-up of the OptiMoM Fortifier Study
Official title: OptiMoM Grows Up: 5.5-year Follow-up of the OptiMoM Fortifier Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Very Low Birth Weight
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Sinai Health System
name: University of Toronto
First posted: 2020-03-16
Enrollment: 149
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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

Primary outcomes:
measure: Full-Scale Intelligence Quotient (IQ)
timeFrame: 5.5 years of age
measure: Growth
timeFrame: 5.5 years of age
Secondary outcomes:
measure: Verbal Comprehension Index
timeFrame: 5.5 years of age
measure: Visual Spatial Index
timeFrame: 5.5 years of age
measure: Working Memory Index
timeFrame: 5.5 years of age
measure: Fluid Reasoning Index
timeFrame: 5.5 years of age
measure: Vocabulary Acquisition Index
timeFrame: 5.5 years of age
measure: Processing Speed Index
timeFrame: 5.5 years of age
measure: Body Composition
timeFrame: 5.5 years of age
measure: Body Composition
timeFrame: 5.5 years of age
measure: Diet Quality
timeFrame: 5.5 years of age
measure: Waist circumference
timeFrame: 5.5 years of age
measure: Blood pressure
timeFrame: 5.5 years of age
Other outcomes:
measure: Affect Recognition domain
timeFrame: 5.5 years of age
measure: Inhibition domain
timeFrame: 5.5 years of age
measure: Design Fluency domain
timeFrame: 5.5 years of age
measure: Statue domain
timeFrame: 5.5 years of age
measure: Visual-Motor Integration
timeFrame: 5.5 years of age
measure: Social-Emotional Functioning
timeFrame: 5.5 years of age
measure: Behaviour and Emotional Response
timeFrame: 5.5 years of age
measure: Executive Functioning
timeFrame: 5.5 years of age
measure: Sensory Processing
timeFrame: 5.5 years of age
measure: Gross Motor Development
timeFrame: 5.5 years of age
measure: Influence of the diet on epigenetic changes
timeFrame: 5.5 years of age
measure: Influence of genetics on taste
timeFrame: 5.5 years of age
measure: Fatty acid status
timeFrame: 5.5 years of age
measure: Children's eating behaviours and dietary intake
timeFrame: 5.5 years of age
measure: Children's eating behaviours
timeFrame: 5.5 years of age
measure: Food parenting and parent dietary intake
timeFrame: 5.5 years of age
measure: Food parenting
timeFrame: 5.5 years of age
measure: Composition and community structure of the gastrointestinal microbiota
timeFrame: 5.5 years of age
measure: Parent and child stress
timeFrame: 5.5 years of age
measure: Parental stress
timeFrame: 5.5 years of age
measure: Home environment- Family Functioning
timeFrame: 5.5 years of age
measure: Home environment- Home Chaos
timeFrame: 5.5 years of age
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References: