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Clinical Trials/NCT02759809
NCT02759809
Completed
Not Applicable

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

The Hospital for Sick Children1 site in 1 country158 target enrollmentJune 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infant, Very Low Birth Weight
Sponsor
The Hospital for Sick Children
Enrollment
158
Locations
1
Primary Endpoint
Full-Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV)
Status
Completed
Last Updated
7 years ago

Overview

Brief 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 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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
July 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Deborah O'Connor

Senior Associate Scientist, Research Institute

The Hospital for Sick Children

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 5.5 years of age

Secondary Outcomes

  • General Language Composite on the WPPSI-IV(5.5 years of age)
  • Verbal IQ on the WPPSI-IV(5.5 years of age)
  • Performance IQ on the WPPSI-IV(5.5 years of age)
  • Processing Speed Quotient on the WPPSI-IV(5.5 years of age)
  • Growth(5.5 years of age)
  • Body Composition(5.5 years of age)

Study Sites (1)

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