Anesthesia Related Neurocognitive Deficits in Children

NCT03034889 | Completed

• 1 other identifier: ANFOLKI-36
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

Anesthesia; Children; General Anesthesia; Neurocognitive Outcome

Outcome Measures

Primary Outcomes (3)

• 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)

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

• 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)

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

• Cognitive Capacity for children between 2 and 4 years of age

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

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

Secondary Outcomes (1)

• Educational status

  1 to 10 years after anesthesia, lasting 30 minutes

Study Arms (2)

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.

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• General anesthesia before the age of 36 months

You may not qualify if:

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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital

Erlangen, Bavaria, 91054, Germany

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 27, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

DE (1)