Exposure to General Anaesthesia in Infancy and Neurocognitive Development

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02182817

Acronym

EGAIN

Enrollment

250

Registered

2014-07-08

Start date

2013-11-30

Completion date

2021-12-31

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Complications of Anesthesia, Impaired Cognition

Keywords

General Anaesthesia, Neurocognitive Development, Behaviour

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 15 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Neurocognitive Assessment: Habituation	6 and 18 months of age	Determines if an infant shows 'novelty preference' when stimuli are shown repeatedly.
Behavioural Assessment: Child behaviour checklist	24 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
Visual Expectation	6 and 18 months of age	—

Countries

Singapore

Outcome results