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Clinical Trials/NCT03034889
NCT03034889
Completed
N/A

Neurocognitive Development in Children Who Received General Anesthesia Before the Age of 3 Years: A Historic-prospective, Controlled, Single Center Cross-section Trial

University of Erlangen-Nürnberg Medical School1 site in 1 country700 target enrollmentJanuary 2017
ConditionsAnesthesia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anesthesia
Sponsor
University of Erlangen-Nürnberg Medical School
Enrollment
700
Locations
1
Primary Endpoint
Cognitive Capacity for children between 7 and 10 years of age
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
March 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Erlangen-Nürnberg Medical School
Responsible Party
Principal Investigator
Principal Investigator

Tino Münster

Prof. Dr.

University of Erlangen-Nürnberg Medical School

Eligibility 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

Outcomes

Primary Outcomes

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)

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)

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)

Secondary Outcomes

  • Educational status(1 to 10 years after anesthesia, lasting 30 minutes)

Study Sites (1)

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