General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics (GAP)

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Infant Development; Anesthesia; Adverse Effect
• Intervention / Treatment: Diagnostic test: Eyetracker; Diagnostic test: Ages & Stages questionnaire; Diagnostic test: Bayley Scale of Infant Development

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.

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Sanne Maat, MD; Phone Number: 0031650100868; Email: s.c.maat@amsterdamumc.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105AZ
      • Recruiting
      • Amsterdam UMC, locatie AMC
      • Contact: J.P.M. Derikx, MD, PhD; Phone Number: +31205665693; Email: j.derikx@amsterdamumc.nl
      • Contact: Jaap Oosterlaan, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: J.P.M. Derikx, MD, PhD, Amsterdam UMC, locatie AMC; Principal Investigator: J. Oosterlaan, Prof., Amsterdam UMC, locatie AMC

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 8, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Anesthesiology; Neuropsychological test; Infant neurodevelopmental disorders
• Other Study ID Numbers: NL71873.018.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No