General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)70 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Anesthesia Infant Development Anesthesia; Adverse Effect

Interventions

EyetrackerDIAGNOSTIC_TEST

Eye-tracking is an objective, non-invasive method and particularly suited to assess neurodevelopmental outcome in infants.

Ages & Stages questionnaireDIAGNOSTIC_TEST

The Ages \& Stages Questionnaire is a conventional instrument used to measure developmental outcome in infants.

Bayley Scale of Infant DevelopmentDIAGNOSTIC_TEST

The Bayley Scale of Infant Development is a conventional instrument used to measure developmental outcome in infants.

Eligibility

Sex: ALLMin age: 11 MonthsMax age: 13 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Amsterdam UMC, locatie AMC

Amsterdam, North Holland, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Neurocognitive development as measured using eye-tracking metrics

Time frame: At the age of 12 months (± four weeks)

Secondary Outcomes

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

Time frame: At the age of 12 months (± four weeks)

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.

Time frame: At the age of 12 months (± four weeks)

Central Contacts

Sanne Maat, MD

CONTACT

0031650100868 s.c.maat@amsterdamumc.nl

Data from ClinicalTrials.gov

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