General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Neurocognitive development as measured using eye-tracking metrics
Study Overview
Brief Summary
This study investigates the impact of different levels of anesthesia exposure on children's neurocognitive development and evaluates the concurrent validity of different methods that assess neurodevelopmental outcome.
Detailed Description
The US Food and Drug Administration (FDA) recently released an official warning regarding the potentially harmful impact of repeated and prolonged (more than three hours) general anesthesia on the child's brain. The potential impact of anesthesia highlights the importance of remediating the need for repeated and prolonged surgery with accompanying anesthesia exposure in a time of cerebral vulnerability and if possible, delay exposure to avoid potentially preventable harm. Therefore, it is crucial to better understand the impact of (different durations and frequencies of) anesthesia exposure on neurodevelopment.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 11 Months to 13 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 12 months (± four weeks) with a history of general anesthesia exposure (patient group) or without a history of general anesthesia (healthy controls)
Exclusion Criteria
- •Children with comorbid conditions affecting structure and/or function of the central nervous system (e.g. premature birth) will be excluded from participation in this study.
Outcomes
Primary Outcomes
Neurocognitive development as measured using eye-tracking metrics
Time Frame: At the age of 12 months (± four weeks)
Neurocognitive development as measured using eye-tracking metrics
Secondary Outcomes
- Conventional measures of neurocognitive development (Ages & Stages Questionnaire and Bayley Scales of Infant Development )(At the age of 12 months (± four weeks))
- Total anesthesia time.(At the age of 12 months (± four weeks))
Investigators
Sanne Maat
Dr. J.P.M. Derikx
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)