OptiMoM Kindergarten Study

The Hospital for Sick Children

Status: Completed

Conditions: Infant, Very Low Birth Weight

Treatments: Other: Preterm formula; Other: Pasteurized donor human breastmilk

Study type: Observational

Funder types: Other

Identifiers

NCT02759809

1000053053

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 5 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

158 participants in 2 patient groups

Children previously assigned to donor milk in the DoMINO trial

Description:

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).

Treatment:

Other: Pasteurized donor human breastmilk

Children previously assigned to formula in the DoMINO trial

Description:

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.

Treatment:

Other: Preterm formula