Surgery in Early Life and Child Development at School-entry: A Population-based Study
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|ClinicalTrials.gov Identifier: NCT02595801|
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : November 17, 2015
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.
|Condition or disease||Intervention/treatment|
|Surgery in Early Childhood||Other: Surgery in early childhood|
|Study Type :||Observational|
|Actual Enrollment :||188628 participants|
|Official Title:||Surgery in Early Life and Child Development at School-entry: A Population-based Study|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Exposure to surgery prior to completion of Early Development Instrument
Other: Surgery in early childhood
Surgical interventions in early childhood (prior to completion of Early Development Instrument)
Other Name: Surgery/Anesthesia in early childhood
No exposure to surgery prior to completion of Early Development Instrument
- 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
- Performance in specific Early Development Instrument domains [ Time Frame: Assessed between five and six years of age ]Vulnerability (percentage in lowest 10th centile); mean score
- Multiple challenge index [ Time Frame: Assessed between five and six years of age ]Vulnerability (percentage in lowest 10th centile) in ≥9 sub-domains of the Early Development Instrument
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595801
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G1X8|