OptiMoM Grows Up: 5.5-year Follow-up of the OptiMoM Fortifier Study
Sponsored by The Hospital for Sick Children
About this trial
Last updated 3 years ago
Study ID
1000065339
Status
Completed
Type
Observational
Placebo
No
Accepting
5 to 6 Years
All
Trial Timing
Ended 4 years ago
What is this trial about?
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.
What are the participation requirements?
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