NCT02759809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

2.1 years

First QC Date

April 26, 2016

Last Update Submit

January 11, 2019

Conditions

Infant, Very Low Birth Weight

Outcome Measures

Primary Outcomes (1)

  • Full-Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV)

    5.5 years of age

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Other Outcomes (9)

  • 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

  • +6 more other outcomes

Study Arms (2)

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

Interventions

Pasteurized donor human breastmilkOTHER
Children previously assigned to donor milk in the DoMINO trial
Preterm formulaOTHER
Children previously assigned to formula in the DoMINO trial

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (4)

  • 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.

    PMID: 35977396DERIVED

  • 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.

    PMID: 35196153DERIVED

  • 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.

    PMID: 33025010DERIVED

  • 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.

    PMID: 31599955DERIVED

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Associate Scientist, Research Institute

Study Record Dates

First Submitted

April 26, 2016

First Posted

May 3, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

January 14, 2019

Record last verified: 2019-01

Locations

CA(1)