Anesthesia, Anesthesia; Adverse Effect, Infant Development
Conditions
Keywords
Anesthesiology, Neuropsychological test, Infant neurodevelopmental disorders
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.
Interventions
DIAGNOSTIC_TESTEyetracker
Eye-tracking is an objective, non-invasive method and particularly suited to assess neurodevelopmental outcome in infants.
DIAGNOSTIC_TESTAges & Stages questionnaire
The Ages & Stages Questionnaire is a conventional instrument used to measure developmental outcome in infants.
DIAGNOSTIC_TESTBayley Scale of Infant Development
The Bayley Scale of Infant Development is a conventional instrument used to measure developmental outcome in infants.
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
11 Months to 13 Months
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurocognitive development as measured using eye-tracking metrics | At the age of 12 months (± four weeks) | Neurocognitive development as measured using eye-tracking metrics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conventional measures of neurocognitive development (Ages & Stages Questionnaire and Bayley Scales of Infant Development ) | At the age of 12 months (± four weeks) | Neurocognitive development as measured using the Ages & Stages Questionnaire and Bayley Scales of Infant Development |
| Total anesthesia time. | At the age of 12 months (± four weeks) | Surgery and anesthesia time will be recorded by the (fellow) surgeon performing the operation(s). When multiple procedures are carried out, durations will be combined and these results will be retrieved during analysis of the data. |
Countries
Netherlands
Contacts
Primary ContactSanne Maat, MD
Outcome results
None listed