Clinical trial NCT04604106: General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics
Official title: General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Infant Development
Anesthesia; Adverse Effect
Keywords: Anesthesiology
Neuropsychological test
Infant neurodevelopmental disorders
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 70
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At the outpatient clinic of the department of pediatric surgery, children (\< 12 months old) who are scheduled for or already underwent a single short, long or repetitive general anesthesia will be identified by the (fellow) pediatric surgeon. Parents/caretakers will be asked to participate in this study by the (fellow) surgeon who will ask informed consent. Healthy controls exist of eligible acquaintances and children that will be recruited via child health care centres by a member of the research team

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Neurocognitive development as measured using eye-tracking metrics
timeFrame: At the age of 12 months (± four weeks)
Secondary outcomes:
measure: Conventional measures of neurocognitive development (Ages & Stages Questionnaire and Bayley Scales of Infant Development )
timeFrame: At the age of 12 months (± four weeks)
measure: Total anesthesia time.
timeFrame: At the age of 12 months (± four weeks)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC - Locatie AMC
name: J.P.M. Derikx, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC - Locatie AMC
name: J. Oosterlaan, Prof.
role: PRINCIPAL_INVESTIGATOR
References: