Prospective Cohort Study of Effects of Exposure to General Anaesthesia in Infancy on Neurocognitive Development
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Central Nervous System Complications of Anesthesia
- Sponsor
- KK Women's and Children's Hospital
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- Neurocognitive Assessment: Bayley's Scale of Infant Development-III
- Last Updated
- 5 years ago
Overview
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.
Detailed Description
We hypothesize that healthy children exposed to general anaesthesia for minor surgery before 15 months of age will have significantly lower neurocognitive scores at 6,18, 24 and 36 months of age compared with age, and gender matched healthy children from the GUSTO cohort without prior exposure to general anaesthesia or surgery. (GUSTO: Growing Up Towards Healthy Outcomes in Singapore: a prospective longitudinal study providing normative data from the local population).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Neurocognitive Assessment: Bayley's Scale of Infant Development-III
Time Frame: 24 months of age
Bayley's Scale of Infant Development-III
Secondary Outcomes
- Neurocognitive Assessment: Habituation(6 and 18 months of age)
- Visual Expectation(6 and 18 months of age)
- Event Related Potential(6 and 18 months of age)
- Neurocognitive Assessment: Deferred Imitation(6 and 18 months of age)
- Behavioural Assessment: Child behaviour checklist(24 months of age)