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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182817
Recruitment Status : Active, not recruiting
First Posted : July 8, 2014
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
Singapore Institute for Clinical Sciences
Information provided by (Responsible Party):
KK Women's and Children's Hospital

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.

Condition or disease
Central Nervous System Complications of Anesthesia Impaired Cognition

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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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study of Effects of Exposure to General Anaesthesia in Infancy on Neurocognitive Development
Study Start Date : November 2013
Actual Primary Completion Date : July 2019
Estimated Study Completion Date : July 2021

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)



Primary Outcome Measures :
  1. Neurocognitive Assessment: Bayley's Scale of Infant Development-III [ Time Frame: 24 months of age ]
    Bayley's Scale of Infant Development-III


Secondary Outcome Measures :
  1. Neurocognitive Assessment: Deferred Imitation [ Time Frame: 6 and 18 months of age ]
    Deferred imitation is used to assess declarative memory

  2. Neurocognitive Assessment: Habituation [ Time Frame: 6 and 18 months of age ]
    Determines if an infant shows 'novelty preference' when stimuli are shown repeatedly.

  3. Behavioural Assessment: Child behaviour checklist [ Time Frame: 24 months of age ]
  4. Event Related Potential [ Time Frame: 6 and 18 months of age ]
    Auditory Oddball

  5. Visual Expectation [ Time Frame: 6 and 18 months of age ]

Biospecimen Retention:   Samples With DNA
Buccal swabs


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Months   (Child)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182817


Locations
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Singapore
Singapore Institute of Clinical Sciences
Singapore, Singapore, 117609
KK Women's and Children's Hospital. 100 Bukit Timah Road
Singapore, Singapore, 229899
Sponsors and Collaborators
KK Women's and Children's Hospital
Singapore Institute for Clinical Sciences
Investigators
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Principal Investigator: Choon L Bong, MBChB FRCA KK Women's and Children's Hospital

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Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT02182817    
Other Study ID Numbers: EGAIN 2013/552/D
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Keywords provided by KK Women's and Children's Hospital:
General Anaesthesia
Neurocognitive Development
Behaviour
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs