OptiMoM Kindergarten Study

Completed

• Conditions: Infant, Very Low Birth Weight
• Interventions: Other: Pasteurized donor human breastmilk; Other: Preterm formula

• Registration Number: NCT02759809
• Lead Sponsor: The Hospital for Sick Children

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-26
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-03
• Study Start: 2016-06
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children previously assigned to donor milk in the DoMINO trial	Pasteurized donor human breastmilk	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).
Children previously assigned to formula in the DoMINO trial	Preterm formula	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.

Primary Outcome Measures

Name	Time	Method
Full-Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV)	5.5 years of age

Secondary Outcome Measures

Name	Time	Method
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
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.
Processing Speed Quotient on the WPPSI-IV	5.5 years of age

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada