Skip to content

OptiMoM Kindergarten Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02759809
Enrollment
158
Registered
2016-05-03
Start date
2016-06-30
Completion date
2018-07-31
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Very Low Birth Weight

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.

Interventions

OTHERPasteurized donor human breastmilk

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 6 Years

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Full-Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV)5.5 years of age

Secondary

MeasureTime frameDescription
Performance IQ on the WPPSI-IV5.5 years of age
General Language Composite on the WPPSI-IV5.5 years of age
Verbal IQ on the WPPSI-IV5.5 years of age
Growth5.5 years of ageGrowth as assessed using weight, height and waist circumference measurements.
Body Composition5.5 years of ageBody composition as assessed using the COSMED BOD POD and skinfold thickness.
Processing Speed Quotient on the WPPSI-IV5.5 years of age

Other

MeasureTime frameDescription
Memory domain on the NEPSY-II5.5 years of age
Influence of the diet on epigenetic changes5.5 years of ageAssessed using a buccal cell biorepository.
Visual-Motor Integration using the Beery5.5 years of age
School Readiness using the Early Development Instrument (EDI)5.5 years of age
Development of Brain Structure5.5 years of ageDevelopment of brain structure as assessed using Magnetic Resonance Imaging (MRI).
Development of Brain Function5.5 years of ageDevelopment of brain function as assessed using Magnetoencephalography (MEG).
Interaction of genetic differences and feeding type on outcomes5.5 years of ageAssessed using a buccal cell biorepository.
Affect Recognition domain on the NEPSY-II5.5 years of age
Language domain on the NEPSY-II5.5 years of age

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026