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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04604106
Other study ID # NL71873.018.19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 21, 2020
Est. completion date March 2023

Study information

Verified date April 2022
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Sanne Maat, MD
Phone 0031650100868
Email s.c.maat@amsterdamumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date March 2023
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Months to 13 Months
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Eyetracker
Eye-tracking is an objective, non-invasive method and particularly suited to assess neurodevelopmental outcome in infants.
Ages & Stages questionnaire
The Ages & Stages Questionnaire is a conventional instrument used to measure developmental outcome in infants.
Bayley Scale of Infant Development
The Bayley Scale of Infant Development is a conventional instrument used to measure developmental outcome in infants.

Locations

Country Name City State
Netherlands Amsterdam UMC, locatie AMC Amsterdam Noord-Holland

Sponsors (1)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
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