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

March 29, 2022 updated by: Deborah O'Connor, The Hospital for Sick Children
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 0A4
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Other: Term-born Comparison
Children born >=37 weeks gestation and weighing more than 2500g

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5.5 years of age
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).
5.5 years of age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Verbal Comprehension Index
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 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
Visual Spatial Index
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 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
Working Memory Index
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 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
Fluid Reasoning Index
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 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
Vocabulary Acquisition Index
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 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
Processing Speed Index
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 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
Body Composition
Time Frame: 5.5 years of age
Trained staff will measure body composition (e.g., % fat mass, % fat-free mass) using air displacement plethysmography, i.e., BODPOD™.
5.5 years of age
Body Composition
Time Frame: 5.5 years of age
Trained staff will measure body composition using bicep, tricep, subscapular and superilliac skinfold thicknesses.
5.5 years of age
Diet Quality
Time Frame: 5.5 years of age
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.
5.5 years of age
Waist circumference
Time Frame: 5.5 years of age
Trained staff will measure waist circumference (cm) at the midpoint between the top of the iliac crest and lowest rib.
5.5 years of age
Blood pressure
Time Frame: 5.5 years of age
Trained staff will measure blood pressure using an automated sphygmomanometer.
5.5 years of age

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Influence of the diet on epigenetic changes
Time Frame: 5.5 years of age
Assessed using a buccal cell biorepository.
5.5 years of age
Affect Recognition domain
Time Frame: 5.5 years of age
Measured using the assessor-administered Developmental Neuropsychological Assessment-Second Edition (NEPSY-II). Scaled scores for each subtest consist of a mean of 10 and a standard deviation of 3 (range of 1-19). Higher scores indicate superior performance.
5.5 years of age
Inhibition domain
Time Frame: 5.5 years of age
Measured using the assessor-administered Developmental Neuropsychological Assessment-Second Edition (NEPSY-II). Scaled scores for each subtest consist of a mean of 10 and a standard deviation of 3 (range of 1-19). Higher scores indicate superior performance.
5.5 years of age
Design Fluency domain
Time Frame: 5.5 years of age
Measured using the assessor-administered Developmental Neuropsychological Assessment-Second Edition (NEPSY-II). Scaled scores for each subtest consist of a mean of 10 and a standard deviation of 3 (range of 1-19). Higher scores indicate superior performance.
5.5 years of age
Statue domain
Time Frame: 5.5 years of age
Measured using the assessor-administered Developmental Neuropsychological Assessment-Second Edition (NEPSY-II). Scaled scores for each subtest consist of a mean of 10 and a standard deviation of 3 (range of 1-19). Higher scores indicate superior performance.
5.5 years of age
Visual-Motor Integration
Time Frame: 5.5 years of age
Measured using the assessor-administered Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI). Standard scores with a mean of 100 and a standard deviation of 15 will be reported. Higher scores on the Beery VMI indicate superior performance.
5.5 years of age
Social-Emotional Functioning
Time Frame: 5.5 years of age
Social-Emotional functioning as measured by parent-report using the Social Responsiveness Scale Second Edition (SRS-2). T-scores on the SRS-2 have a mean of 50 and standard deviation of 10. Higher scores are associated with more severe social impairments.
5.5 years of age
Behaviour and Emotional Response
Time Frame: 5.5 years of age
Behaviour and Emotional Response as measured by parent-report using the Behavior Assessment System for Children-Third Edition (BASC-3). Scores are expressed as T-scores with a mean of 50 and standard deviation of 10. Higher values indicate increased risk for composites of clinical scales and lower risk for the composite of adaptive scales.
5.5 years of age
Executive Functioning
Time Frame: 5.5 years of age
Executive Functioning as measured by parent-report using the Behavioral Rating Inventory of Executive Function (BRIEF). T-scores have a mean of 50 and a standard deviation of 10. Higher scores indicate a potential problematic area of clinical significance.
5.5 years of age
Sensory Processing
Time Frame: 5.5 years of age
Sensory Processing related to auditory, visual, touch, movement, body position and oral processing as measured by parent-report using the Sensory Profile Second Edition (Sensory Profile-2). Higher scores indicating higher sensitivity in each category.
5.5 years of age
Gross Motor Development
Time Frame: 5.5 years of age
Measured using the assessor-administered Movement Assessment Battery for Children Second Edition (Movement ABC-2). Higher scores indicate superior performance.
5.5 years of age
Influence of genetics on taste
Time Frame: 5.5 years of age
Assessed using a buccal cell biorepository.
5.5 years of age
Fatty acid status
Time Frame: 5.5 years of age
Assessed using a buccal cell biorepository.
5.5 years of age
Children's eating behaviours and dietary intake
Time Frame: 5.5 years of age
Assessed using direct observation during a standardized lunch protocol.
5.5 years of age
Children's eating behaviours
Time Frame: 5.5 years of age
Assessed by parent-report using the Child Eating Behaviour Questionnaire (CEBQ). The CEBQ is made up of eight scales: Food responsiveness, Emotional over-eating, Enjoyment of food, Desire to drink, Satiety responsiveness, Slowness in eating, Emotional under-eating, and Food fussiness. Higher scores indicate higher frequency behaviour.
5.5 years of age
Food parenting and parent dietary intake
Time Frame: 5.5 years of age
Assessed using direct observation during a standardized lunch protocol.
5.5 years of age
Food parenting
Time Frame: 5.5 years of age
Assessed by parent-report using the Comprehensive Feeding Practices Questionnaire (CFPQ). The questionnaire contains 12 scales: 'Encourage Balance and Variety', 'Environment', 'Involvement', 'Modeling', 'Monitoring', 'Teaching about Nutrition', 'Emotion Regulation', 'Food as Reward', 'Pressure', 'Child Control', 'Restriction for Health' and 'Restriction for Weight Control'; higher scores indicate higher frequency behaviour.
5.5 years of age
Composition and community structure of the gastrointestinal microbiota
Time Frame: 5.5 years of age
High-throughput sequencing of microbial DNA from stool samples
5.5 years of age
Parent and child stress
Time Frame: 5.5 years of age
Measured using cortisol levels obtained from hair samples collected from both parent and child at the posterior vertex.
5.5 years of age
Parental stress
Time Frame: 5.5 years of age
Measured by parent-report using the Parent Distress sub-scale of the Parenting Stress Index Short Form (PSI-SF). Higher scores indicate higher levels of parental distress.
5.5 years of age
Home environment- Family Functioning
Time Frame: 5.5 years of age
Family functioning will be measured by parent-report using the General Functioning sub-scale of the Family Assessment Device (FAD). Higher scores indicate lower levels of functioning (problem solving, communication, etc.).
5.5 years of age
Home environment- Home Chaos
Time Frame: 5.5 years of age
Home Chaos will be measured by parent-report using the Confusion, Hubbub and Order Scale (CHAOS). Higher scores indicate a more chaotic home environment.
5.5 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Toronto
Sinai Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1000065339

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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