Exposure to General Anaesthesia in Infancy and Neurocognitive Development (EGAIN)

February 18, 2021 updated by: KK Women's and Children's Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 117609
        • Singapore Institute of Clinical Sciences
      • Singapore, Singapore, 229899
        • KK Women's and Children's Hospital. 100 Bukit Timah Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Full-term infants with no significant co-morbidities presenting for minor surgery at KK Womens' and children's hospital, Singapore

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
GA-Exposed Group
Exposure to general anaesthesia below 15 months of age
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Collaborators

Singapore Institute for Clinical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

July 1, 2019

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

June 10, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 8, 2014

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGAIN 2013/552/D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Impaired Cognition

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe