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Completed

NCT Number: NCT03034889

Anesthesia Related Neurocognitive Deficits in Children

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.

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Key information

Conditions

Anesthesia

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Erlangen, Bavaria, 91054, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Educational status

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

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

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Acronym: ANFOLKI-36

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 27, 2017
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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