|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
1 March 2021 |
|
Main ID: |
NCT02182817 |
|
Date of registration:
|
10/06/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Exposure to General Anaesthesia in Infancy and Neurocognitive Development
EGAIN |
|
Scientific title:
|
Prospective Cohort Study of Effects of Exposure to General Anaesthesia in Infancy on Neurocognitive Development |
|
Date of first enrolment:
|
November 2013 |
|
Target sample size:
|
250 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02182817 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Singapore
| | | | | | | |
|
Contacts
|
|
Name:
|
Choon L Bong, MBChB FRCA |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
KK Women's and Children's Hospital |
| | |
|
Key inclusion & exclusion 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
Age minimum:
N/A
Age maximum:
15 Months
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Impaired Cognition
|
|
Central Nervous System Complications of Anesthesia
|
|
Primary Outcome(s)
|
|
Neurocognitive Assessment: Bayley's Scale of Infant Development-III
[Time Frame: 24 months of age]
|
|
Secondary Outcome(s)
|
|
Visual Expectation
[Time Frame: 6 and 18 months of age]
|
|
Behavioural Assessment: Child behaviour checklist
[Time Frame: 24 months of age]
|
|
Event Related Potential
[Time Frame: 6 and 18 months of age]
|
|
Neurocognitive Assessment: Habituation
[Time Frame: 6 and 18 months of age]
|
|
Neurocognitive Assessment: Deferred Imitation
[Time Frame: 6 and 18 months of age]
|
|
Secondary ID(s)
|
|
EGAIN 2013/552/D
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|