General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics

Anesthesia Clinical Trial

— GAP  

Official title:

General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04604106
• Other study ID #: NL71873.018.19
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Anesthesia
• Anesthesia; Adverse Effect
• Infant Development

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)