Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04604106
Status:
UNKNOWN
Last Update Posted:
2022-04-11
First Post:
2020-10-21
Brief Title:
General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GAP
Brief Summary:
This study investigates the impact of different levels of anesthesia exposure on childrens 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 childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None