Surgery in Early Childhood Clinical Trial
Official title:
Surgery in Early Life and Child Development at School-entry: A Population-based Study
| Verified date | November 2015 |
| Source | The Hospital for Sick Children |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 188628 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 6 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Canada | The Hospital for Sick Children | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| The Hospital for Sick Children | Institute for Clinical Evaluative Sciences, McMaster University |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Early developmental vulnerability | Any major domain of the Early Development Instrument in the lowest 10th percentile | Assessed between five and six years of age | No |
| Secondary | Performance in specific Early Development Instrument domains | Vulnerability (percentage in lowest 10th centile); mean score | Assessed between five and six years of age | No |
| Secondary | Multiple challenge index | Vulnerability (percentage in lowest 10th centile) in =9 sub-domains of the Early Development Instrument | Assessed between five and six years of age | No |