Surgery in Early Life and Child Development at School-entry: A Population-based Study
NCT ID: NCT02595801
Last Updated: 2015-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
188628 participants
OBSERVATIONAL
2014-08-31
2015-11-30
Brief Summary
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The secondary hypothesis is that frequency of surgery and anesthesia exposure in children with immature structural and functional brain development has a dose-dependent association with worsened child development outcomes at school-entry.
The overall objective is to investigate the association between surgery/anesthesia exposure(s) in children in Ontario and major child development outcomes (physical health and well being, social competence, emotional maturity, and language and cognitive development) at school entry as measured by the Early Development Instrument.
Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Exposed
Exposure to surgery prior to completion of Early Development Instrument
Surgery in early childhood
Surgical interventions in early childhood (prior to completion of Early Development Instrument)
Reference
No exposure to surgery prior to completion of Early Development Instrument
No interventions assigned to this group
Interventions
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Surgery in early childhood
Surgical interventions in early childhood (prior to completion of Early Development Instrument)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Not born in Canada
* Having undergone fetal interventions, radiation or brachytherapy, local pharmacotherapy, systemic cancer chemotherapeutic procedures, therapeutic interventions of the cardiovascular system
* Patients of a cardiology or cardiovascular service
6 Years
ALL
No
Sponsors
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McMaster University
OTHER
Institute for Clinical Evaluative Sciences
OTHER
The Hospital for Sick Children
OTHER
Responsible Party
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James O'Leary
Staff Anesthesiologist
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Other Identifiers
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1000046454
Identifier Type: -
Identifier Source: org_study_id