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

K

KK Women's and Children's Hospital

Status

Unknown

Conditions

Central Nervous System Complications of Anesthesia
Impaired Cognition

Study type

Observational

Funder types

Other

Identifiers

NCT02182817
EGAIN 2013/552/D

Details and patient eligibility

About

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.

Full 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).

Enrollment

250 patients

Sex

All

Ages

1 day to 15 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

GA-Exposed Group
Description:
Exposure to general anaesthesia below 15 months of age
Unexposed Group
Description:
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)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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