Anesthesia Related Neurocognitive Deficits in Children

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03034889

Acronym

ANFOLKI-36

Enrollment

700

Registered

2017-01-27

Start date

2017-01-31

Completion date

2020-03-31

Last updated

2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Anesthesia, Children, General Anesthesia, Neurocognitive Outcome

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

4 Years to 10 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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)
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)

Secondary

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

Countries

Germany

Outcome results