Infant, Very Low Birth WeightNCT04308902
OptiMoM Grows Up: 5.5-year Follow-up of the OptiMoM Fortifier Study
An observational study of Infant, Very Low Birth Weight, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Infant, Very Low Birth Weight
- What is being tested?
- VLBW and Term-born Comparison
- How many people
- 149 participants
- Where
- 1 siteCanada
- Study dates
- 12 Mar 2020to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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]
Who cannot join
- For term-born comparison only: a child with any chromosomal or congenital anomaly affecting growth
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- VLBW, Term-born Comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLBWOther
Participants previously enrolled in the Bovine vs. Human Milk-Based Fortifier Study
Term-born ComparisonOther
Children born >=37 weeks gestation and weighing more than 2500g
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Term-born Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 5.5 years of age
Secondary outcomes (11)
Verbal Comprehension Index
Measured using the assessor-administered Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV). The WPPSI-IV composite sub-scales are standardized to a mean of 100, with a standard deviation of 15. Higher scores indicate superior performance.
Measured: 5.5 years of age
Visual Spatial Index
Measured using the assessor-administered Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV). The WPPSI-IV composite sub-scales are standardized to a mean of 100, with a standard deviation of 15. Higher scores indicate superior performance.
Measured: 5.5 years of age
Working Memory Index
Measured using the assessor-administered Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV). The WPPSI-IV composite sub-scales are standardized to a mean of 100, with a standard deviation of 15. Higher scores indicate superior performance.
Measured: 5.5 years of age
Fluid Reasoning Index
Measured using the assessor-administered Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV). The WPPSI-IV composite sub-scales are standardized to a mean of 100, with a standard deviation of 15. Higher scores indicate superior performance.
Measured: 5.5 years of age
Vocabulary Acquisition Index
Measured using the assessor-administered Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV). The WPPSI-IV composite sub-scales are standardized to a mean of 100, with a standard deviation of 15. Higher scores indicate superior performance.
Measured: 5.5 years of age
Processing Speed Index
Measured using the assessor-administered Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV). The WPPSI-IV composite sub-scales are standardized to a mean of 100, with a standard deviation of 15. Higher scores indicate superior performance.
Measured: 5.5 years of age
Body Composition
Trained staff will measure body composition (e.g., % fat mass, % fat-free mass) using air displacement plethysmography, i.e., BODPOD™.
Measured: 5.5 years of age
Body Composition
Trained staff will measure body composition using bicep, tricep, subscapular and superilliac skinfold thicknesses.
Measured: 5.5 years of age
Diet Quality
Diet Quality as measured using the Healthy Eating Index calculated from two 24-hour recalls conducted by trained staff. Scores on the Healthy Eating Index range from 0-100 with higher scores indicated higher diet quality.
Measured: 5.5 years of age
Waist circumference
Trained staff will measure waist circumference (cm) at the midpoint between the top of the iliac crest and lowest rib.
Measured: 5.5 years of age
Blood pressure
Trained staff will measure blood pressure using an automated sphygmomanometer.
Measured: 5.5 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start12 Mar 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, Very Low Birth WeightStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Sinai Health System, University of Toronto
- Responsible party
- Principal investigator, Deborah O'Connor, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308902
- Sponsor's protocol ID
- 1000065339
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41072552
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OptiMoM Grows Up: 5.5-year Follow-up of the OptiMoM Fortifier Study
- ClinicalTrials.gov ID
- NCT04308902
- Acronym / sponsor ID
- 1000065339
- Conditions
- Infant, Very Low Birth Weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Sinai Health System, University of Toronto
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children previously enrolled in the OptiMoM Fortifier Study | – | Other: VLBWThis 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. |
| Term-born Comparison | – | Other: Term-born ComparisonThis 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. |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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]
Key exclusion criteria (1 listed)
- For term-born comparison only: a child with any chromosomal or congenital anomaly affecting growth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VLBWParticipants previously enrolled in the Bovine vs. Human Milk-Based Fortifier Study | Other | Children previously enrolled in the OptiMoM Fortifier Study |
| Term-born ComparisonChildren born >=37 weeks gestation and weighing more than 2500g | Other | Term-born Comparison |
Primary outcome
Full-Scale Intelligence Quotient (IQ)
Time frame: 5.5 years of age
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.
Growth
Time frame: 5.5 years of age
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).
11 secondary outcomes
Verbal Comprehension Index
Time frame: 5.5 years of age
Visual Spatial Index
Time frame: 5.5 years of age
Working Memory Index
Time frame: 5.5 years of age
Fluid Reasoning Index
Time frame: 5.5 years of age
Vocabulary Acquisition Index
Time frame: 5.5 years of age
Processing Speed Index
Time frame: 5.5 years of age
Body Composition
Time frame: 5.5 years of age
Body Composition
Time frame: 5.5 years of age
Diet Quality
Time frame: 5.5 years of age
Waist circumference
Time frame: 5.5 years of age
Blood pressure
Time frame: 5.5 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 41072552Walton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Very Low Birth Weight, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full-Scale Intelligence Quotient (IQ) (time frame: 5.5 years of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04308902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.