OptiMoM Kindergarten Study

Infant, Very Low Birth Weight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02759809
• Other study ID #: 1000053053
• Status: Completed
• Start date: June 2016
• Est. completion date: July 2018

Study information

• Verified date: January 2019
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Gender: All
• Age group: 5 Years to 6 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Birth Weight
• Infant, Very Low Birth Weight

Intervention

Other:
• Pasteurized donor human breastmilk

• Preterm formula

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Affect Recognition domain on the NEPSY-II		5.5 years of age
Other	Language domain on the NEPSY-II		5.5 years of age
Other	Memory domain on the NEPSY-II		5.5 years of age
Other	Visual-Motor Integration using the Beery		5.5 years of age
Other	Development of Brain Structure	Development of brain structure as assessed using Magnetic Resonance Imaging (MRI).	5.5 years of age
Other	Development of Brain Function	Development of brain function as assessed using Magnetoencephalography (MEG).	5.5 years of age
Other	Interaction of genetic differences and feeding type on outcomes	Assessed using a buccal cell biorepository.	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	School Readiness using the Early Development Instrument (EDI)		5.5 years of age
Primary	Full-Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV)		5.5 years of age
Secondary	Verbal IQ on the WPPSI-IV		5.5 years of age
Secondary	Performance IQ on the WPPSI-IV		5.5 years of age
Secondary	General Language Composite on the WPPSI-IV		5.5 years of age
Secondary	Processing Speed Quotient on the WPPSI-IV		5.5 years of age
Secondary	Growth	Growth as assessed using weight, height and waist circumference measurements.	5.5 years of age
Secondary	Body Composition	Body composition as assessed using the COSMED BOD POD and skinfold thickness.	5.5 years of age

External Links

•   Donor Milk for Improved Neurodevelopmental Outcomes (DoMINO) trial