OptiMoM Kindergarten Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Children previously assigned to donor milk in the DoMINO trial This study is an observational study of children who were enrolled in a previous trial (DoMINO trial) between 2010 and 2012 during which they were randomized to receive donor milk when mother's own breastmilk was unavailable. Donor milk was from a milk bank part of the Human Milk Banking Association of North America (HMBANA). |
Other: Pasteurized donor human breastmilk
|
| Children previously assigned to formula in the DoMINO trial This study is an observational study of children who were enrolled in a previous trial (DoMINO trial) between 2010 and 2012 during which they were randomized to receive preterm formula when mother's own breastmilk was unavailable. Preterm formula was either Similac Special Care or Enfamil Premature depending on hospital contract with formula companies. |
Other: Preterm formula
|
Outcome Measures
Primary Outcome Measures
- Full-Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV) [5.5 years of age]
Secondary Outcome Measures
- Verbal IQ on the WPPSI-IV [5.5 years of age]
- Performance IQ on the WPPSI-IV [5.5 years of age]
- General Language Composite 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]
Growth as assessed using weight, height and waist circumference measurements.
- Body Composition [5.5 years of age]
Body composition as assessed using the COSMED BOD POD and skinfold thickness.
Other Outcome Measures
- Affect Recognition domain on the NEPSY-II [5.5 years of age]
- Language domain on the NEPSY-II [5.5 years of age]
- Memory domain on the NEPSY-II [5.5 years of age]
- Visual-Motor Integration using the Beery [5.5 years of age]
- Development of Brain Structure [5.5 years of age]
Development of brain structure as assessed using Magnetic Resonance Imaging (MRI).
- Development of Brain Function [5.5 years of age]
Development of brain function as assessed using Magnetoencephalography (MEG).
- Interaction of genetic differences and feeding type on outcomes [5.5 years of age]
Assessed using a buccal cell biorepository.
- Influence of the diet on epigenetic changes [5.5 years of age]
Assessed using a buccal cell biorepository.
- School Readiness using the Early Development Instrument (EDI) [5.5 years of age]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Children who were enrolled in the DoMINO (Donor Milk for Improved Neurodevelopmental Outcomes) trial (ISRCTN35317141).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Hospital for Sick Children | Toronto | Ontario | Canada | M5G 1X8 |
Sponsors and Collaborators
- The Hospital for Sick Children
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1000053053