Surgery in Early Life and Child Development at School-entry: A Population-based Study

Study Overview
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Brief Summary
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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.

Official Title
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Surgery in Early Life and Child Development at School-entry: A Population-based Study

Conditions
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Surgery in Early Childhood

Intervention / Treatment
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* Other: Surgery in early childhood


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed<br>Exposure to surgery prior to completion of Early Development Instrument | Other: Surgery in early childhood<br>* Surgical interventions in early childhood (prior to completion of Early Development Instrument)<br>* Other names: Surgery/Anesthesia in early childhood;|
| Reference<br>No exposure to surgery prior to completion of Early Development Instrument | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early developmental vulnerability | Any major domain of the Early Development Instrument in the lowest 10th percentile | Assessed between five and six years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance in specific Early Development Instrument domains | Vulnerability (percentage in lowest 10th centile); mean score | Assessed between five and six years of age | 
| 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 |