Exposure to General Anaesthesia in Infancy and Neurocognitive Development

Study Overview
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Brief Summary
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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
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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).

Official Title
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Prospective Cohort Study of Effects of Exposure to General Anaesthesia in Infancy on Neurocognitive Development

Conditions
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Central Nervous System Complications of Anesthesia, Impaired Cognition

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 15 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GA-Exposed Group<br>Exposure to general anaesthesia below 15 months of age | |
| Unexposed Group<br>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) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive Assessment: Bayley's Scale of Infant Development-III | Bayley's Scale of Infant Development-III | 24 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive Assessment: Deferred Imitation | Deferred imitation is used to assess declarative memory | 6 and 18 months of age | 
| Neurocognitive Assessment: Habituation | Determines if an infant shows 'novelty preference' when stimuli are shown repeatedly. | 6 and 18 months of age | 
| Behavioural Assessment: Child behaviour checklist |  | 24 months of age | 
| Event Related Potential | Auditory Oddball | 6 and 18 months of age | 
| Visual Expectation |  | 6 and 18 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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General Anaesthesia, Neurocognitive Development, Behaviour