Exposure to General Anaesthesia in Infancy and Neurocognitive Development

• Conditions: Central Nervous System Complications of Anesthesia; Impaired Cognition

• Registration Number: NCT02182817
• Lead Sponsor: KK Women's and Children's Hospital

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).

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-08
• Primary Completion: 2019-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurocognitive Assessment: Bayley's Scale of Infant Development-III	24 months of age	Bayley's Scale of Infant Development-III

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Singapore Institute of Clinical Sciences; 🇸🇬 Singapore, Singapore

KK Women's and Children's Hospital. 100 Bukit Timah Road; 🇸🇬 Singapore, Singapore