Exposure to General Anaesthesia in Infancy and Neurocognitive Development

Impaired Cognition Clinical Trial

— EGAIN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02182817
• Other study ID #: EGAIN 2013/552/D
• Status: Active, not recruiting
• Start date: November 2013
• Est. completion date: December 2021

Study information

• Verified date: January 2021
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 2021
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 15 Months

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Complications of Anesthesia
• Cognitive Dysfunction
• Impaired Cognition

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital. 100 Bukit Timah Road	Singapore
Singapore	Singapore Institute of Clinical Sciences	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital	Singapore Institute for Clinical Sciences

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive Assessment: Bayley's Scale of Infant Development-III	Bayley's Scale of Infant Development-III	24 months of age
Secondary	Neurocognitive Assessment: Deferred Imitation	Deferred imitation is used to assess declarative memory	6 and 18 months of age
Secondary	Neurocognitive Assessment: Habituation	Determines if an infant shows 'novelty preference' when stimuli are shown repeatedly.	6 and 18 months of age
Secondary	Behavioural Assessment: Child behaviour checklist		24 months of age
Secondary	Event Related Potential	Auditory Oddball	6 and 18 months of age
Secondary	Visual Expectation		6 and 18 months of age