General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics

• Conditions: Infant Development; Anesthesia; Anesthesia; Adverse Effect
• Interventions: Diagnostic Test: Eyetracker; Diagnostic Test: Ages & Stages questionnaire; Diagnostic Test: Bayley Scale of Infant Development

• Registration Number: NCT04604106
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Timeline

• Study Start: 2020-10-21
• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-27
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-04-11
• Primary Completion: 2022-12
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient group	Eyetracker	Infant aged 12 months (± four weeks) with a history of general anesthesia exposure
Patient group	Ages & Stages questionnaire	Infant aged 12 months (± four weeks) with a history of general anesthesia exposure
Healthy subject group	Ages & Stages questionnaire	Infant aged 12 months (± four weeks) without a history of general anesthesia
Healthy subject group	Bayley Scale of Infant Development	Infant aged 12 months (± four weeks) without a history of general anesthesia
Patient group	Bayley Scale of Infant Development	Infant aged 12 months (± four weeks) with a history of general anesthesia exposure
Healthy subject group	Eyetracker	Infant aged 12 months (± four weeks) without a history of general anesthesia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Amsterdam UMC, locatie AMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands