Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02595801
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : November 17, 2015
Sponsor:
Collaborators:
McMaster University
Institute for Clinical Evaluative Sciences
Information provided by (Responsible Party):
James O'Leary, 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.


Condition or disease Intervention/treatment
Surgery in Early Childhood Other: Surgery in early childhood

Layout table for study information
Study Type : Observational
Actual Enrollment : 188628 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


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 Name: Surgery/Anesthesia in early childhood

Reference
No exposure to surgery prior to completion of Early Development Instrument



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children attending public or Catholic school in Ontario who have completed the Early Development Instrument
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
The Hospital for Sick Children
McMaster University
Institute for Clinical Evaluative Sciences

Layout table for additonal information
Responsible Party: James O'Leary, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02595801     History of Changes
Other Study ID Numbers: 1000046454
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015