NCT04308902

OptiMoM Grows Up: 5.5-year Follow-up of the OptiMoM Fortifier Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 149 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 5 Years – 6 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infant, Very Low Birth Weight

Interventions

Type	Name	Description
OTHER	VLBW	Participants previously enrolled in the Bovine vs. Human Milk-Based Fortifier Study
OTHER	Term-born Comparison	Children born \>=37 weeks gestation and weighing more than 2500g

Timeline

• Start date: 2020-03-12
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-03-16
• Last updated: 2022-03-31

Locations

1 site across 1 country: Canada