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

NCT04308902 | Completed

• 1 other identifier: 1000065339
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Full-Scale Intelligence Quotient (IQ)

  Measured using the assessor-administered Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV). The WPPSI-IV Full-scale IQ and all composite sub-scales are standardized to a mean of 100, with a standard deviation of 15. Higher scores indicate superior performance.

  5.5 years of age

• Growth

  Growth as assessed by weight in kilograms (kg) and height in meters (m) measured by trained staff to assess body mass index (BMI). BMI will be the ratio of weight (kg) to the square of height (m).

  5.5 years of age

Secondary Outcomes (11)

• Verbal Comprehension Index

  5.5 years of age

• Visual Spatial Index

  5.5 years of age

• Working Memory Index

  5.5 years of age

• Fluid Reasoning Index

  5.5 years of age

• Vocabulary Acquisition Index

  5.5 years of age

Other Outcomes (22)

• Affect Recognition domain

  5.5 years of age

• Inhibition domain

  5.5 years of age

• Design Fluency domain

  5.5 years of age

Study Arms (2)

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.

Other: VLBW

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.

Other: Term-born Comparison

Interventions

VLBW OTHER

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

Children previously enrolled in the OptiMoM Fortifier Study

Term-born Comparison OTHER

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

Term-born Comparison

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Very low birth weight infants previously enrolled in the Bovine vs. Human Milk-Based Fortifier Study (NCT02137473) and a comparison group of children born full-term (\>=37 weeks gestation) and weighing \>2500g.

You may qualify if:

• Children who were enrolled in the Bovine vs. Human Milk-Based Fortifier Study (NCT02137473)
• Children who were born \>=37 weeks gestation and weighing \> 2500g \[Term-born comparison group\]

You may not qualify if:

• For term-born comparison only: a child with any chromosomal or congenital anomaly affecting growth

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Sinai Health System: collaborator
• University of Toronto: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 0A4, Canada

Location

Related Publications (1)

• Walton K, Hopperton KE, Lambis A, Law N, Vaz S, Kiss A, Unger SL, O'Connor DL. Caregiver feeding practices, dietary intake and weight status of very low birthweight infants compared to term-born peers at school-entry. Appetite. 2026 Feb 1;217:108338. doi: 10.1016/j.appet.2025.108338. Epub 2025 Oct 8.

  PMID: 41072552 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Scientist

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 16, 2020
• Study Start: March 12, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CA (1)