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

November 16, 2015 updated by: James O'Leary, The Hospital for Sick Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

188628

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposed
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 Names:
  • Surgery/Anesthesia in early childhood
Reference
No exposure to surgery prior to completion of Early Development Instrument

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed between five and six years of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed between five and six years of age
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
Assessed between five and six years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

McMaster University
Institute for Clinical Evaluative Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 1000046454

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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