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Completed

NCT Number: NCT02759809

OptiMoM Kindergarten 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 VLBW infants who in hospital were fed: donor milk or preterm formula and/or mother's milk. Areas of development to be assessed include: cognition, language, motor skills, brain structure/function, and body composition. A DNA biorepository will also be created.

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Key information

Conditions

Infant, Very Low Birth Weight

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

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

Inclusion criteria

  • Children who were enrolled in the DoMINO (Donor Milk for Improved Neurodevelopmental Outcomes) trial (ISRCTN35317141).

Treatment and study plan

Pasteurized donor human breastmilk

Other

Preterm formula

Other

Primary outcomes

  1. Full-Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV)

    Time frame: 5.5 years of age

Secondary outcomes

  1. Verbal IQ on the WPPSI-IV

    Time frame: 5.5 years of age

  2. Performance IQ on the WPPSI-IV

    Time frame: 5.5 years of age

  3. General Language Composite on the WPPSI-IV

    Time frame: 5.5 years of age

  4. Processing Speed Quotient on the WPPSI-IV

    Time frame: 5.5 years of age

  5. Growth

    Time frame: 5.5 years of age

    Growth as assessed using weight, height and waist circumference measurements.

  6. Body Composition

    Time frame: 5.5 years of age

    Body composition as assessed using the COSMED BOD POD and skinfold thickness.

Other outcomes

  1. Affect Recognition domain on the NEPSY-II

    Time frame: 5.5 years of age

  2. Language domain on the NEPSY-II

    Time frame: 5.5 years of age

  3. Memory domain on the NEPSY-II

    Time frame: 5.5 years of age

  4. Visual-Motor Integration using the Beery

    Time frame: 5.5 years of age

  5. Development of Brain Structure

    Time frame: 5.5 years of age

    Development of brain structure as assessed using Magnetic Resonance Imaging (MRI).

  6. Development of Brain Function

    Time frame: 5.5 years of age

    Development of brain function as assessed using Magnetoencephalography (MEG).

  7. Interaction of genetic differences and feeding type on outcomes

    Time frame: 5.5 years of age

    Assessed using a buccal cell biorepository.

  8. Influence of the diet on epigenetic changes

    Time frame: 5.5 years of age

    Assessed using a buccal cell biorepository.

  9. School Readiness using the Early Development Instrument (EDI)

    Time frame: 5.5 years of age

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Optimizing Mothers' Milk for Preterm Infants (OptiMoM) Program of Research: Study 1-Impact of Donor Milk at Kindergarten

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 3, 2016
Registry last updated
Jan 14, 2019

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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