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

NCT02595801 | Completed

• 1 other identifier: 1000046454
• Study Type: observational
• Target: 188,628
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery in Early Childhood

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Performance in specific Early Development Instrument domains

  Assessed between five and six years of age

• Multiple challenge index

  Assessed between five and six years of age

Study Arms (2)

Exposed

Exposure to surgery prior to completion of Early Development Instrument

Other: Surgery in early childhood

Reference

No exposure to surgery prior to completion of Early Development Instrument

Interventions

Surgery in early childhood OTHER

Surgical interventions in early childhood (prior to completion of Early Development Instrument)

Also known as: Surgery/Anesthesia in early childhood

Exposed

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children attending public or Catholic school in Ontario who have completed the Early Development Instrument

You may qualify if:

• Completion of the Early Development Instrument in Ontario

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• McMaster University: collaborator
• Institute for Clinical Evaluative Sciences: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Interventions

Surgical Procedures, Operative; Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 3, 2015
• Study Start: August 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

CA (1)