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CompletedNCT03034889ANFOLKI-36Updated Mar 24, 2020

Anesthesia Related Neurocognitive Deficits in Children

An observational study in Anesthesia, sponsored by University of Erlangen-Nürnberg Medical School. Completed at 1 site in Germany. Open to participants aged 4 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-24.

Sponsored by University of Erlangen-Nürnberg Medical School · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
700
Ages
4 Years to 10 Years
Sex
All
01

Study summary

The infantile brain has to pass essential, mayor steps in the first 36 months of life. During that period of development it is particularly vulnerable to toxic, exogenic influences. This study wants to review the long-term effects of children who were exposed to anesthesia in the first three years of their life. Therefore the investigators will examine children at age of 4-10 that were exposed to anesthesia and compare their neurocognitive capacity to children who did not have any exposure to anesthesia. The investigators plan on measuring the intelligence quotient using standardized tests which will be performed by a trained psychologist. In addition there will be a questionnaire concerning behavioral characteristics and educational development which is filled by the parents. The exposed children will be recruited from our preexisting database, the control group will be recruited from practitioners and the pediatric walk-in-clinic.

02

Conditions studied

  • Anesthesia

Keywords

  • Anesthesia
  • Children
  • General Anesthesia
  • Neurocognitive Outcome
03

In context

Lead sponsor

University of Erlangen-Nürnberg Medical School is the lead sponsor of 267 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children age 4-10 who underwent general anesthesia below the age of 36 months in context of surgical or diagnostic procedures or sedation uring intensive care.

Inclusion criteria

  • General anesthesia before the age of 36 months

Exclusion criteria

Exclusion Criteria:

  • neurosurgical interventions
  • cardiac surgery
  • preexisting hereditary or acquired cognitive deficits
  • no informed consent
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
700 participants (actual)
Patient registry
No

Groups and cohorts

  • Exposed

    Children age 4-10 who required general anesthesia before the age of 36 months in the context of surgical and diagnostic procedures or sedation during intensive care, excluding neurosurgical interventions or cardiac surgery as well as preexisting hereditary or acquired neurocognitive deficits

  • Control

    Children age 4-10 who did not require any anesthesia before the age of 36 months. Excluding preexisting hereditary or acquired neurocognitive deficits.

06

What researchers measure

Primary outcomes

  1. Cognitive Capacity for children between 7 and 10 years of age

    Standardized tests for intelligence quotient (IQ): Kaufman Assessment Battery for Children - Second Edition (KABC-II)

    Time frame: Test is done 1 to 10 years after anesthesia and is lasting 3 hours

  2. Cognitive Capacity for children between 4 and 7 years of age

    Standardized tests for intelligence quotient (IQ): Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III)

    Time frame: Test is done 1 to 10 years after anesthesia and is lasting 3 hours

  3. Cognitive Capacity for children between 2 and 4 years of age

    Standardized tests for intelligence quotient (IQ): Wechsler Intelligence Scale for Children (WISC-IV)

    Time frame: Test is done 1 to 10 years after anesthesia and is lasting 3 hours

Secondary outcomes

  1. Educational status

    Questionnaire, filled by parents 1-10 years after anesthesia exposure

    Time frame: 1 to 10 years after anesthesia, lasting 30 minutes

07

Study locations

1 site
  • University Hospital
    Erlangen, Bavaria 91054, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03034889
Lead sponsor
University of Erlangen-Nürnberg Medical School
Responsible party
Tino Münster (Prof. Dr., University of Erlangen-Nürnberg Medical School) — Principal investigator
First posted
Jan 27, 2017
Start date
Jan 2017
Primary completion
Dec 2019
Completion
Mar 2020
Last update
Mar 24, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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