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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-12

Study Completion Date

2021-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Infant, Very Low Birth Weight

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

VLBW

Intervention Type OTHER

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.

Term-born Comparison

Intervention Type OTHER

Children born \>=37 weeks gestation and weighing more than 2500g

Interventions

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VLBW

Participants previously enrolled in the Bovine vs. Human Milk-Based Fortifier Study

Intervention Type OTHER

Term-born Comparison

Children born \>=37 weeks gestation and weighing more than 2500g

Intervention Type OTHER

Eligibility Criteria

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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 \[Term-born comparison group\]