NCT04604106

General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 11 Months – 13 Months
• Healthy volunteers: Accepted

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.

Conditions

• Anesthesia
• Infant Development
• Anesthesia; Adverse Effect

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Eyetracker	Eye-tracking is an objective, non-invasive method and particularly suited to assess neurodevelopmental outcome in infants.
DIAGNOSTIC_TEST	Ages & Stages questionnaire	The Ages \& Stages Questionnaire is a conventional instrument used to measure developmental outcome in infants.
DIAGNOSTIC_TEST	Bayley Scale of Infant Development	The Bayley Scale of Infant Development is a conventional instrument used to measure developmental outcome in infants.

Timeline

• Start date: 2020-10-21
• Primary completion: 2022-12-01
• Completion: 2023-03-01
• First posted: 2020-10-27
• Last updated: 2022-04-11

Locations

1 site across 1 country: Netherlands