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

Infant, Very Low Birth Weight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04308902
• Other study ID #: 1000065339
• Status: Completed
• Start date: March 12, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2022
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Infant, Very Low Birth Weight

Intervention

Other:
• VLBW
Participants previously enrolled in the Bovine vs. Human Milk-Based Fortifier Study
• Term-born Comparison
Children born >=37 weeks gestation and weighing more than 2500g

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Sinai Health System, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Affect Recognition domain	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
Other	Inhibition domain	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
Other	Design Fluency domain	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
Other	Statue domain	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
Other	Visual-Motor Integration	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
Other	Social-Emotional Functioning	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
Other	Behaviour and Emotional Response	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
Other	Executive Functioning	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
Other	Sensory Processing	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
Other	Gross Motor Development	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
Other	Influence of the diet on epigenetic changes	Assessed using a buccal cell biorepository.	5.5 years of age
Other	Influence of genetics on taste	Assessed using a buccal cell biorepository.	5.5 years of age
Other	Fatty acid status	Assessed using a buccal cell biorepository.	5.5 years of age
Other	Children's eating behaviours and dietary intake	Assessed using direct observation during a standardized lunch protocol.	5.5 years of age
Other	Children's eating behaviours	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
Other	Food parenting and parent dietary intake	Assessed using direct observation during a standardized lunch protocol.	5.5 years of age
Other	Food parenting	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
Other	Composition and community structure of the gastrointestinal microbiota	High-throughput sequencing of microbial DNA from stool samples	5.5 years of age
Other	Parent and child stress	Measured using cortisol levels obtained from hair samples collected from both parent and child at the posterior vertex.	5.5 years of age
Other	Parental stress	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
Other	Home environment- Family Functioning	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
Other	Home environment- Home Chaos	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
Primary	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
Primary	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	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.	5.5 years of age
Secondary	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.	5.5 years of age
Secondary	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.	5.5 years of age
Secondary	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.	5.5 years of age
Secondary	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.	5.5 years of age
Secondary	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.	5.5 years of age
Secondary	Body Composition	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
Secondary	Body Composition	Trained staff will measure body composition using bicep, tricep, subscapular and superilliac skinfold thicknesses.	5.5 years of age
Secondary	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.	5.5 years of age
Secondary	Waist circumference	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
Secondary	Blood pressure	Trained staff will measure blood pressure using an automated sphygmomanometer.	5.5 years of age