Infant, Very Low Birth WeightNCT02759809
OptiMoM Kindergarten Study
An observational study of Infant, Very Low Birth Weight, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 5 to 6 years
- Conditions the study is for
- Infant, Very Low Birth Weight
- What is being tested?
- Pasteurized donor human breastmilk and Preterm formula
- How many people
- 158 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 6 years
- All sexes
- Child
Study population: Very low birth weight infants previously enrolled in the DoMINO (Donor Milk for Improved Neurodevelopmental Outcomes) trial (ISRCTN35317141).
Who may be able to join
- Children who were enrolled in the DoMINO (Donor Milk for Improved Neurodevelopmental Outcomes) trial (ISRCTN35317141).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Infant, Very Low Birth Weight
- Being tested
- Pasteurized donor human breastmilk, Preterm formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasteurized donor human breastmilkOther
Preterm formulaOther
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Preterm formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full-Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV)
Measured: 5.5 years of age
Secondary outcomes (6)
Verbal IQ on the WPPSI-IV
Measured: 5.5 years of age
Performance IQ on the WPPSI-IV
Measured: 5.5 years of age
General Language Composite on the WPPSI-IV
Measured: 5.5 years of age
Processing Speed Quotient on the WPPSI-IV
Measured: 5.5 years of age
Growth
Growth as assessed using weight, height and waist circumference measurements.
Measured: 5.5 years of age
Body Composition
Body composition as assessed using the COSMED BOD POD and skinfold thickness.
Measured: 5.5 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infant, Very Low Birth WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah O'Connor, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759809
- Sponsor's protocol ID
- 1000053053
- Status last verified
- Jan 2019
- First submitted
- 26 Apr 2016
- Last updated
- 14 Jan 2019
- Results posted
- No
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.
PubMed 35977396Walton 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.
PubMed 35196153McGee 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.
PubMed 33025010McGee 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.
PubMed 31599955
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Mothers' Milk for Preterm Infants (OptiMoM) Program of Research: Study 1-Impact of Donor Milk at Kindergarten
- ClinicalTrials.gov ID
- NCT02759809
- Acronym / sponsor ID
- 1000053053
- Conditions
- Infant, Very Low Birth Weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children previously assigned to donor milk in the DoMINO trial | – | Other: Pasteurized donor human breastmilkThis 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 | – | Other: Preterm formulaThis 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. |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- Very low birth weight infants previously enrolled in the DoMINO (Donor Milk for Improved Neurodevelopmental Outcomes) trial (ISRCTN35317141).
Key inclusion criteria (1 listed)
- Children who were enrolled in the DoMINO (Donor Milk for Improved Neurodevelopmental Outcomes) trial (ISRCTN35317141).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pasteurized donor human breastmilk | Other | Children previously assigned to donor milk in the DoMINO trial |
| Preterm formula | Other | Children previously assigned to formula in the DoMINO trial |
Primary outcome
Full-Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV)
Time frame: 5.5 years of age
6 secondary outcomes
Verbal IQ on the WPPSI-IV
Time frame: 5.5 years of age
Performance IQ on the WPPSI-IV
Time frame: 5.5 years of age
General Language Composite on the WPPSI-IV
Time frame: 5.5 years of age
Processing Speed Quotient on the WPPSI-IV
Time frame: 5.5 years of age
Growth
Time frame: 5.5 years of age
Body Composition
Time frame: 5.5 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Derived from this study: PubMed 35977396Xu 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.
- Derived from this study: PubMed 35196153Walton 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.
- Derived from this study: PubMed 33025010McGee 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.
- Derived from this study: PubMed 31599955McGee 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.
- Donor Milk for Improved Neurodevelopmental Outcomes (DoMINO) trialLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Very Low Birth Weight, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full-Scale IQ on the Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV) (time frame: 5.5 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02759809, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.