Anesthesia Related Neurocognitive Deficits in Children

Completed

• Conditions: Anesthesia

• Registration Number: NCT03034889
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-27
• Primary Completion: 2019-12
• Status Verified: 2020-03
• Study Completion: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive Capacity for children between 4 and 7 years of age	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)
Cognitive Capacity for children between 2 and 4 years of age	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 7 and 10 years of age	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)

Secondary Outcome Measures

Name	Time	Method
Educational status	1 to 10 years after anesthesia, lasting 30 minutes	Questionnaire, filled by parents 1-10 years after anesthesia exposure

Trial Locations

Locations (1)

University Hospital; 🇩🇪 Erlangen, Bavaria, Germany