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Clinical Trials/NCT02658526
NCT02658526
Withdrawn
Not Applicable

Role of Anesthesia / Surgery on Cognitive Function in Child

Konstanze Plaschke1 site in 1 countryDecember 2015
ConditionsBehavioral

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Behavioral
Sponsor
Konstanze Plaschke
Locations
1
Primary Endpoint
Global cognitive abilities
Status
Withdrawn
Last Updated
5 years ago

Overview

Brief Summary

The role of surgical stress and anesthesia is unknown in the early childhood. In vitro and animal studies showed a risk for treatment with anesthesia in the developmental brain. Furthermore, stress is also an important risk factor for cognitive impairment. Therefore, the investigators want to investigate in a clinical prospective cohort study the role anesthesia and surgery on different cognitive parameters and self-controling mechanisms in children under 3 years.

Detailed Description

In order to investigate the role of anesthesia and / or surgery on cognitive abilities the investigators want to perform a prospective cohort study in children under 3 years. Three groups should be compared: i) control without anesthesia / surgery, ii) children with only anesthesia, and iii) children with both surgery and anesthesia. All children will be investigate before and after intervention. Different behavioral scales will be used for detailed cognitive abilities and self-regulatory skills.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
December 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Konstanze Plaschke
Responsible Party
Sponsor Investigator
Principal Investigator

Konstanze Plaschke

Prof.

Heidelberg University

Eligibility Criteria

Inclusion Criteria

  • Age 9 month to 3 years with or without anesthesia / surgery

Exclusion Criteria

  • Psychiatrical, neurological, oncological diseases

Outcomes

Primary Outcomes

Global cognitive abilities

Time Frame: 4-6 weeks

Early Childhood Behavior Questionnaire (ECBQ) questionnaire

Secondary Outcomes

  • surgery-associated data(1 day)

Study Sites (1)

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