Anesthesia Related Neurocognitive Deficits in Children

Anesthesia Clinical Trial

— ANFOLKI-36  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034889
• Other study ID #: ANFOLKI-36
• Status: Completed
• Start date: January 2017
• Est. completion date: March 2020

Study information

• Verified date: March 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: March 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Locations

Country	Name	City	State
Germany	University Hospital	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Educational status	Questionnaire, filled by parents 1-10 years after anesthesia exposure	1 to 10 years after anesthesia, lasting 30 minutes