Exposure to General Anaesthesia in Infancy and Neurocognitive Development

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2021-12-31

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.

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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).

Conditions

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Central Nervous System Complications of Anesthesia Impaired Cognition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GA-Exposed Group

Exposure to general anaesthesia below 15 months of age

No interventions assigned to this group

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)

No interventions assigned to this group

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

Minimum Eligible Age

1 Day

Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes