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Completed

NCT Number: NCT02595801

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

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.

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Key information

Conditions

Surgery in Early Childhood

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery in early childhood

Other

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

Other names: Surgery/Anesthesia in early childhood

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Institute for Clinical Evaluative Sciences
  • McMaster University

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 3, 2015
Registry last updated
Nov 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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