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

T

The Hospital for Sick Children

Status

Completed

Conditions

Surgery in Early Childhood

Treatments

Other: Surgery in early childhood

Study type

Observational

Funder types

Other

Identifiers

NCT02595801
1000046454

Details and patient eligibility

About

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.

Enrollment

188,628 patients

Sex

All

Ages

Under 6 years old

Volunteers

No Healthy Volunteers

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

Trial design

188,628 participants in 2 patient groups

Exposed
Description:
Exposure to surgery prior to completion of Early Development Instrument
Treatment:
Other: Surgery in early childhood
Reference
Description:
No exposure to surgery prior to completion of Early Development Instrument

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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