CClinicalTrials.gg
Status unknownNCT02182817EGAINUpdated Feb 21, 2021

Exposure to General Anaesthesia in Infancy and Neurocognitive Development

An observational study in Central Nervous System Complications of Anesthesia and Impaired Cognition, sponsored by KK Women's and Children's Hospital. Status unknown at 2 sites in Singapore. Open to participants aged 1 Day to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-21.

Sponsored by KK Women's and Children's Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
1 Day to 15 Months
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Central Nervous System Complications of Anesthesia
  • Impaired Cognition

Keywords

  • General Anaesthesia
  • Neurocognitive Development
  • Behaviour
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In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 250 is above the median of 150 across 950 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

KK Women's and Children's Hospital is the lead sponsor of 136 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Day to 15 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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)

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What researchers measure

Primary outcomes

  1. Neurocognitive Assessment: Bayley's Scale of Infant Development-III

    Bayley's Scale of Infant Development-III

    Time frame: 24 months of age

Secondary outcomes

  1. Neurocognitive Assessment: Deferred Imitation

    Deferred imitation is used to assess declarative memory

    Time frame: 6 and 18 months of age

  2. Neurocognitive Assessment: Habituation

    Determines if an infant shows 'novelty preference' when stimuli are shown repeatedly.

    Time frame: 6 and 18 months of age

  3. Behavioural Assessment: Child behaviour checklist

    Time frame: 24 months of age

  4. Event Related Potential

    Auditory Oddball

    Time frame: 6 and 18 months of age

  5. Visual Expectation

    Time frame: 6 and 18 months of age

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02182817
Lead sponsor
KK Women's and Children's Hospital
Collaborators
Institute for Human Development and Potential (IHDP), Singapore
Responsible party
Sponsor
First posted
Jul 8, 2014
Start date
Nov 2013
Primary completion
Jul 2019
Completion
Dec 2021 (estimated)
Last update
Feb 21, 2021

Study contacts

Choon L Bong, MBChB FRCA
principal investigator · KK Women's and Children's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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