Exposure to General Anaesthesia in Infancy and Neurocognitive Development
EGAIN
Prospective Cohort Study of Effects of Exposure to General Anaesthesia in Infancy on Neurocognitive Development
1 other identifier
observational
250
1 country
2
Brief Summary
This prospective cohort study aims to determine if apparently healthy children with no significant co-morbidities who undergo general anaesthesia for minor surgery before 15 months of age will develop measurable deficits in neurocognitive development compared to apparently healthy children with no significant co-morbidities who do not undergo general anaesthesia or surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 10, 2014
CompletedFirst Posted
Study publicly available on registry
July 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFebruary 21, 2021
January 1, 2021
5.7 years
June 10, 2014
February 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neurocognitive Assessment: Bayley's Scale of Infant Development-III
Bayley's Scale of Infant Development-III
24 months of age
Secondary Outcomes (5)
Neurocognitive Assessment: Deferred Imitation
6 and 18 months of age
Neurocognitive Assessment: Habituation
6 and 18 months of age
Behavioural Assessment: Child behaviour checklist
24 months of age
Event Related Potential
6 and 18 months of age
Visual Expectation
6 and 18 months of age
Study Arms (2)
GA-Exposed Group
Exposure to general anaesthesia below 15 months of age
Unexposed Group
Children not exposed to general anaesthesia or surgery from GUSTO cohort. (GUSTO: Growing Up Towards Healthy Outcomes in Singapore: a prospective longitudinal study providing normative data from the local population)
Eligibility Criteria
Full-term infants with no significant co-morbidities presenting for minor surgery at KK Womens' and children's hospital, Singapore
You may qualify if:
- Infants born \> 36 weeks gestation
- No significant co-morbidities
- Who undergo general sevoflurane anaesthesia for minor surgery lasting \<150 minutes (including herniotomies, orchidopexies, circumcisions and pyloromyotomies) before 15 months of age
You may not qualify if:
- Prematurity \<36 weeks gestation
- Birth weight less than 2400g
- Presence of a genetic or chromosomal disorder
- Disorder of the central nervous system, including any seizure disorder
- Major congenital cardiac defects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Singapore Institute of Clinical Sciences
Singapore, 117609, Singapore
KK Women's and Children's Hospital. 100 Bukit Timah Road
Singapore, 229899, Singapore
Biospecimen
Buccal swabs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Choon L Bong, MBChB FRCA
KK Women's and Children's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2014
First Posted
July 8, 2014
Study Start
November 1, 2013
Primary Completion
July 1, 2019
Study Completion
December 1, 2021
Last Updated
February 21, 2021
Record last verified: 2021-01