General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics (GAP)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Unknown

Conditions

Anesthesia; Adverse Effect

Infant Development

Anesthesia

Treatments

Diagnostic Test: Eyetracker

Diagnostic Test: Ages & Stages questionnaire

Diagnostic Test: Bayley Scale of Infant Development

Study type

Observational

Funder types

Other

Identifiers

NCT04604106

NL71873.018.19

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

11 to 13 months old

Volunteers

Accepts Healthy Volunteers

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.