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

Completed

• Conditions: Surgery in Early Childhood
• Interventions: Other: Surgery in early childhood

• Registration Number: NCT02595801
• Lead Sponsor: The Hospital for Sick Children

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188628

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed	Surgery in early childhood	Exposure to surgery prior to completion of Early Development Instrument

Primary Outcome Measures

Name	Time	Method
Early developmental vulnerability	Assessed between five and six years of age	Any major domain of the Early Development Instrument in the lowest 10th percentile

Secondary Outcome Measures

Name	Time	Method
Performance in specific Early Development Instrument domains	Assessed between five and six years of age	Vulnerability (percentage in lowest 10th centile); mean score
Multiple challenge index	Assessed between five and six years of age	Vulnerability (percentage in lowest 10th centile) in ≥9 sub-domains of the Early Development Instrument

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada