Anesthesia Clinical Trial
— GAPOfficial title:
General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics
NCT number | NCT04604106 |
Other study ID # | NL71873.018.19 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 21, 2020 |
Est. completion date | March 2023 |
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | March 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 11 Months to 13 Months |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC, locatie AMC | Amsterdam | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurocognitive development as measured using eye-tracking metrics | Neurocognitive development as measured using eye-tracking metrics | At the age of 12 months (± four weeks) | |
Secondary | Conventional measures of neurocognitive development (Ages & Stages Questionnaire and Bayley Scales of Infant Development ) | Neurocognitive development as measured using the Ages & Stages Questionnaire and Bayley Scales of Infant Development | At the age of 12 months (± four weeks) | |
Secondary | Total anesthesia time. | 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. | At the age of 12 months (± four weeks) |
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