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Completed

NCT Number: NCT04308902

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

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Key information

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 0A4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VLBW

Other

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

Term-born Comparison

Other

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

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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. 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.

  6. 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.

  7. 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™.

  8. Body Composition

    Time frame: 5.5 years of age

    Trained staff will measure body composition using bicep, tricep, subscapular and superilliac skinfold thicknesses.

  9. 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.

  10. 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.

  11. Blood pressure

    Time frame: 5.5 years of age

    Trained staff will measure blood pressure using an automated sphygmomanometer.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Influence of the diet on epigenetic changes

    Time frame: 5.5 years of age

    Assessed using a buccal cell biorepository.

  12. Influence of genetics on taste

    Time frame: 5.5 years of age

    Assessed using a buccal cell biorepository.

  13. Fatty acid status

    Time frame: 5.5 years of age

    Assessed using a buccal cell biorepository.

  14. Children's eating behaviours and dietary intake

    Time frame: 5.5 years of age

    Assessed using direct observation during a standardized lunch protocol.

  15. 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.

  16. Food parenting and parent dietary intake

    Time frame: 5.5 years of age

    Assessed using direct observation during a standardized lunch protocol.

  17. 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.

  18. Composition and community structure of the gastrointestinal microbiota

    Time frame: 5.5 years of age

    High-throughput sequencing of microbial DNA from stool samples

  19. 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.

  20. 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.

  21. 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.).

  22. 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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Sinai Health System
  • University of Toronto

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2020
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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