NCT04604106

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

2.1 years

First QC Date

October 21, 2020

Last Update Submit

April 8, 2022

Conditions

AnesthesiaInfant DevelopmentAnesthesia; Adverse Effect

Keywords

AnesthesiologyNeuropsychological testInfant neurodevelopmental disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Conventional measures of neurocognitive development (Ages & Stages Questionnaire and Bayley Scales of Infant Development )

    At the age of 12 months (± four weeks)

  • Total anesthesia time.

    At the age of 12 months (± four weeks)

Study Arms (2)

Patient group

Infant aged 12 months (± four weeks) with a history of general anesthesia exposure

Diagnostic Test: EyetrackerDiagnostic Test: Ages & Stages questionnaireDiagnostic Test: Bayley Scale of Infant Development

Healthy subject group

Infant aged 12 months (± four weeks) without a history of general anesthesia

Diagnostic Test: EyetrackerDiagnostic Test: Ages & Stages questionnaireDiagnostic Test: Bayley Scale of Infant Development

Interventions

EyetrackerDIAGNOSTIC_TEST

Eye-tracking is an objective, non-invasive method and particularly suited to assess neurodevelopmental outcome in infants.

Healthy subject groupPatient group
Ages & Stages questionnaireDIAGNOSTIC_TEST

The Ages \& Stages Questionnaire is a conventional instrument used to measure developmental outcome in infants.

Healthy subject groupPatient group
Bayley Scale of Infant DevelopmentDIAGNOSTIC_TEST

The Bayley Scale of Infant Development is a conventional instrument used to measure developmental outcome in infants.

Healthy subject groupPatient group

Eligibility Criteria

Age11 Months - 13 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • Age 12 months (± four weeks) with a history of general anesthesia exposure (patient group) or without a history of general anesthesia (healthy controls)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC, locatie AMC

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Study Officials

  • J.P.M. Derikx, MD, PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

  • J. Oosterlaan, Prof.

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanne Maat, MD

CONTACT

0031650100868s.c.maat@amsterdamumc.nl

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. J.P.M. Derikx

Study Record Dates

First Submitted

October 21, 2020

First Posted

October 27, 2020

Study Start

October 21, 2020

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Locations

NL(1)