Clinical trial NCT02182817: Exposure to General Anaesthesia in Infancy and Neurocognitive Development
Official title: Prospective Cohort Study of Effects of Exposure to General Anaesthesia in Infancy on Neurocognitive Development
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Central Nervous System Complications of Anesthesia
Impaired Cognition
Keywords: General Anaesthesia
Neurocognitive Development
Behaviour
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Institute for Human Development and Potential (IHDP), Singapore
First posted: 2014-07-08
Enrollment: 250
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

Eligibility 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

Primary outcomes:
measure: Neurocognitive Assessment: Bayley's Scale of Infant Development-III
timeFrame: 24 months of age
Secondary outcomes:
measure: Neurocognitive Assessment: Deferred Imitation
timeFrame: 6 and 18 months of age
measure: Neurocognitive Assessment: Habituation
timeFrame: 6 and 18 months of age
measure: Behavioural Assessment: Child behaviour checklist
timeFrame: 24 months of age
measure: Event Related Potential
timeFrame: 6 and 18 months of age
measure: Visual Expectation
timeFrame: 6 and 18 months of age
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Institute of Clinical Sciences
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital. 100 Bukit Timah Road
Study officials:
affiliation: KK Women's and Children's Hospital
name: Choon L Bong, MBChB FRCA
role: PRINCIPAL_INVESTIGATOR
References: