General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics

Study Overview
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Brief Summary
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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
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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.

Official Title
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General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics

Conditions
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Anesthesia, Infant Development, Anesthesia; Adverse Effect

Intervention / Treatment
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* Diagnostic Test: Eyetracker
* Diagnostic Test: Ages & Stages questionnaire
* Diagnostic Test: Bayley Scale of Infant Development


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Months
Maximum Age: 13 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient group<br>Infant aged 12 months (± four weeks) with a history of general anesthesia exposure | Diagnostic Test: Eyetracker<br>* Eye-tracking is an objective, non-invasive method and particularly suited to assess neurodevelopmental outcome in infants.<br>Diagnostic Test: Ages & Stages questionnaire<br>* The Ages & Stages Questionnaire is a conventional instrument used to measure developmental outcome in infants.<br>Diagnostic Test: Bayley Scale of Infant Development<br>* The Bayley Scale of Infant Development is a conventional instrument used to measure developmental outcome in infants.<br>|
| Healthy subject group<br>Infant aged 12 months (± four weeks) without a history of general anesthesia | Diagnostic Test: Eyetracker<br>* Eye-tracking is an objective, non-invasive method and particularly suited to assess neurodevelopmental outcome in infants.<br>Diagnostic Test: Ages & Stages questionnaire<br>* The Ages & Stages Questionnaire is a conventional instrument used to measure developmental outcome in infants.<br>Diagnostic Test: Bayley Scale of Infant Development<br>* The Bayley Scale of Infant Development is a conventional instrument used to measure developmental outcome in infants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive development as measured using eye-tracking metrics | Neurocognitive development as measured using eye-tracking metrics | At the age of 12 months (± four weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | At the age of 12 months (± four weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesiology, Neuropsychological test, Infant neurodevelopmental disorders