Surgery in Early Life and Child Development at School-entry: A Population-based Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 188,628
- Locations
- 1
- Primary Endpoint
- Early developmental vulnerability
Overview
Brief Summary
The central hypothesis is that surgery and anesthesia exposure in children with immature structural and functional brain development has long-term adverse effects on child development at school-entry compared with children not exposed to anesthesia.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- — to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Completion of the Early Development Instrument in Ontario
Exclusion Criteria
- •Children with physical or developmental disabilities identified in the Early Development Instrument
- •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
Outcomes
Primary Outcomes
Early developmental vulnerability
Time Frame: Assessed between five and six years of age
Any major domain of the Early Development Instrument in the lowest 10th percentile
Secondary Outcomes
- Performance in specific Early Development Instrument domains(Assessed between five and six years of age)
- Multiple challenge index(Assessed between five and six years of age)
Investigators
James O'Leary
Staff Anesthesiologist
The Hospital for Sick Children