OptiMoM Kindergarten Study

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

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.

Study Overview

• Status: Completed
• Conditions: Infant, Very Low Birth Weight
• Intervention / Treatment: Other: Pasteurized donor human breastmilk; Other: Preterm formula

• Study Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 6 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Very low birth weight infants previously enrolled in the DoMINO (Donor Milk for Improved Neurodevelopmental Outcomes) trial (ISRCTN35317141).

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Growth as assessed using weight, height and waist circumference measurements.	5.5 years of age
Body Composition	Body composition as assessed using the COSMED BOD POD and skinfold thickness.	5.5 years of age

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Development of brain structure as assessed using Magnetic Resonance Imaging (MRI).	5.5 years of age
Development of Brain Function	Development of brain function as assessed using Magnetoencephalography (MEG).	5.5 years of age
Interaction of genetic differences and feeding type on outcomes	Assessed using a buccal cell biorepository.	5.5 years of age
Influence of the diet on epigenetic changes	Assessed using a buccal cell biorepository.	5.5 years of age
School Readiness using the Early Development Instrument (EDI)		5.5 years of age

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children

Publications and helpful links

General Publications

• Xu J, Shin J, McGee M, Unger S, Bando N, Sato J, Vandewouw M, Patel Y, Branson HM, Paus T, Pausova Z, O'Connor DL. Intake of mother's milk by very-low-birth-weight infants and variation in DNA methylation of genes involved in neurodevelopment at 5.5 years of age. Am J Clin Nutr. 2022 Oct 6;116(4):1038-1048. doi: 10.1093/ajcn/nqac221.
• Walton K, McGee M, Sato J, Law N, Hopperton KE, Bando N, Kiss A, Unger SL, O'Connor DL. Social-emotional functioning and dietary intake among children born with a very low birth weight. Appl Physiol Nutr Metab. 2022 Jul 1;47(7):737-748. doi: 10.1139/apnm-2021-0434. Epub 2022 Feb 23.
• McGee M, Unger S, Hamilton J, Birken CS, Pausova Z, Kiss A, Bando N, O'Connor DL. Associations between Diet Quality and Body Composition in Young Children Born with Very Low Body Weight. J Nutr. 2020 Nov 19;150(11):2961-2968. doi: 10.1093/jn/nxaa281.
• McGee M, Unger S, Hamilton J, Birken CS, Pausova Z, Kiss A, Bando N, O'Connor DL. Adiposity and Fat-Free Mass of Children Born with Very Low Birth Weight Do Not Differ in Children Fed Supplemental Donor Milk Compared with Those Fed Preterm Formula. J Nutr. 2020 Feb 1;150(2):331-339. doi: 10.1093/jn/nxz234.

Helpful Links

• Donor Milk for Improved Neurodevelopmental Outcomes (DoMINO) trial

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: April 26, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 11, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 1000053053