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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02595801
Enrollment
188628
Registered
2015-11-03
Start date
2014-08-31
Completion date
2015-11-30
Last updated
2015-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery in Early Childhood

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.

Interventions

OTHERSurgery in early childhood

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

Sponsors

McMaster University
CollaboratorOTHER
Institute for Clinical Evaluative Sciences
CollaboratorOTHER
The Hospital for Sick Children
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Early developmental vulnerabilityAssessed between five and six years of ageAny major domain of the Early Development Instrument in the lowest 10th percentile

Secondary

MeasureTime frameDescription
Performance in specific Early Development Instrument domainsAssessed between five and six years of ageVulnerability (percentage in lowest 10th centile); mean score
Multiple challenge indexAssessed between five and six years of ageVulnerability (percentage in lowest 10th centile) in ≥9 sub-domains of the Early Development Instrument

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026