Trials / Completed
CompletedNCT02595801
Surgery in Early Life and Child Development at School-entry: A Population-based Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 188,628 (actual)
- Sponsor
- The Hospital for Sick Children · Academic / Other
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Surgery in early childhood | Surgical interventions in early childhood (prior to completion of Early Development Instrument) |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2015-11-01
- Completion
- 2015-11-01
- First posted
- 2015-11-03
- Last updated
- 2015-11-17
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02595801. Inclusion in this directory is not an endorsement.