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

The Hospital for Sick Children

Status: Completed

Conditions: Infant, Very Low Birth Weight

Treatments: Other: VLBW; Other: Term-born Comparison

Study type: Observational

Funder types: Other

Identifiers

NCT04308902

1000065339

Details and patient eligibility

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.

Enrollment: 149 patients

Sex: All

Ages: 5 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

149 participants in 2 patient groups

Children previously enrolled in the OptiMoM Fortifier Study

Description:

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.

Treatment:

Other: VLBW

Term-born Comparison

Description:

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.

Treatment:

Other: Term-born Comparison