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

NCT04308902 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 149

Last updated 2022-03-31

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sinai Health System

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Eligibility

Min Age
5 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-12
Primary Completion
2021-12-01
Completion
2021-12-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04308902 on ClinicalTrials.gov