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Anesthesia Related Neurocognitive Deficits in Children (ANFOLKI-36)

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ClinicalTrials.gov Identifier: NCT03034889
Recruitment Status : Enrolling by invitation
First Posted : January 27, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Tino Münster, University of Erlangen-Nürnberg Medical School

Brief 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.

Condition or disease
Anesthesia

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Study Type : Observational
Estimated Enrollment : 1400 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Neurocognitive Development in Children Who Received General Anesthesia Before the Age of 3 Years: A Historic-prospective, Controlled, Single Center Cross-section Trial
Actual Study Start Date : January 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Group/Cohort
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.



Primary Outcome Measures :
  1. Cognitive Capacity for children between 7 and 10 years of age [ Time Frame: Test is done 1 to 10 years after anesthesia and is lasting 3 hours ]
    Standardized tests for intelligence quotient (IQ): Kaufman Assessment Battery for Children - Second Edition (KABC-II)

  2. Cognitive Capacity for children between 4 and 7 years of age [ Time Frame: Test is done 1 to 10 years after anesthesia and is lasting 3 hours ]
    Standardized tests for intelligence quotient (IQ): Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III)

  3. Cognitive Capacity for children between 2 and 4 years of age [ Time Frame: Test is done 1 to 10 years after anesthesia and is lasting 3 hours ]
    Standardized tests for intelligence quotient (IQ): Wechsler Intelligence Scale for Children (WISC-IV)


Secondary Outcome Measures :
  1. Educational status [ Time Frame: 1 to 10 years after anesthesia, lasting 30 minutes ]
    Questionnaire, filled by parents 1-10 years after anesthesia exposure



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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

  • General anesthesia before the age of 36 months

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034889


Locations
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Germany
University Hospital
Erlangen, Bavaria, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School

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Responsible Party: Tino Münster, Prof. Dr., University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03034889     History of Changes
Other Study ID Numbers: ANFOLKI-36
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

Keywords provided by Tino Münster, University of Erlangen-Nürnberg Medical School:
Anesthesia
Children
General Anesthesia
Neurocognitive Outcome

Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs