<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03034889</url>
  </required_header>
  <id_info>
    <org_study_id>ANFOLKI-36</org_study_id>
    <nct_id>NCT03034889</nct_id>
  </id_info>
  <brief_title>Anesthesia Related Neurocognitive Deficits in Children</brief_title>
  <acronym>ANFOLKI-36</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The infantile brain has to pass essential, mayor steps in the first 36 months of life. During&#xD;
      that period of development it is particularly vulnerable to toxic, exogenic influences. This&#xD;
      study wants to review the long-term effects of children who were exposed to anesthesia in the&#xD;
      first three years of their life. Therefore the investigators will examine children at age of&#xD;
      4-10 that were exposed to anesthesia and compare their neurocognitive capacity to children&#xD;
      who did not have any exposure to anesthesia. The investigators plan on measuring the&#xD;
      intelligence quotient using standardized tests which will be performed by a trained&#xD;
      psychologist. In addition there will be a questionnaire concerning behavioral characteristics&#xD;
      and educational development which is filled by the parents. The exposed children will be&#xD;
      recruited from our preexisting database, the control group will be recruited from&#xD;
      practitioners and the pediatric walk-in-clinic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">March 2020</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive Capacity for children between 7 and 10 years of age</measure>
    <time_frame>Test is done 1 to 10 years after anesthesia and is lasting 3 hours</time_frame>
    <description>Standardized tests for intelligence quotient (IQ): Kaufman Assessment Battery for Children - Second Edition (KABC-II)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive Capacity for children between 4 and 7 years of age</measure>
    <time_frame>Test is done 1 to 10 years after anesthesia and is lasting 3 hours</time_frame>
    <description>Standardized tests for intelligence quotient (IQ): Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive Capacity for children between 2 and 4 years of age</measure>
    <time_frame>Test is done 1 to 10 years after anesthesia and is lasting 3 hours</time_frame>
    <description>Standardized tests for intelligence quotient (IQ): Wechsler Intelligence Scale for Children (WISC-IV)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Educational status</measure>
    <time_frame>1 to 10 years after anesthesia, lasting 30 minutes</time_frame>
    <description>Questionnaire, filled by parents 1-10 years after anesthesia exposure</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">700</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Exposed</arm_group_label>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Children age 4-10 who did not require any anesthesia before the age of 36 months. Excluding preexisting hereditary or acquired neurocognitive deficits.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Children age 4-10 who underwent general anesthesia below the age of 36 months in context of&#xD;
        surgical or diagnostic procedures or sedation uring intensive care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  General anesthesia before the age of 36 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neurosurgical interventions&#xD;
&#xD;
          -  cardiac surgery&#xD;
&#xD;
          -  preexisting hereditary or acquired cognitive deficits&#xD;
&#xD;
          -  no informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Erlangen</city>
        <state>Bavaria</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Erlangen-Nürnberg Medical School</investigator_affiliation>
    <investigator_full_name>Tino Münster</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>Anesthesia</keyword>
  <keyword>Children</keyword>
  <keyword>General Anesthesia</keyword>
  <keyword>Neurocognitive Outcome</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03034889
org study id: ANFOLKI-36
nct id: NCT03034889
lead sponsor: 
has dmc: No
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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: 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
description: Standardized tests for intelligence quotient (IQ): Kaufman Assessment Battery for Children - Second Edition (KABC-II)
measure: 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
description: Standardized tests for intelligence quotient (IQ): Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III)
measure: 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
description: Standardized tests for intelligence quotient (IQ): Wechsler Intelligence Scale for Children (WISC-IV)
measure: Educational status
time frame: 1 to 10 years after anesthesia, lasting 30 minutes
description: Questionnaire, filled by parents 1-10 years after anesthesia exposure
arm group label: Exposed
description: 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
arm group label: Control
description: Children age 4-10 who did not require any anesthesia before the age of 36 months. Excluding preexisting hereditary or acquired neurocognitive deficits.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Erlangen-Nürnberg Medical School
investigator full name: Tino Münster
investigator title: Prof. Dr.