Cognitive Changes in Childs After Anesthesia / Surgery

NCT ID: NCT02658526

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Behavioral

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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control

children without anesthesia / surgery

No interventions assigned to this group

anesthesia

children with anesthesia for diagnostic reason

anesthesia - surgery

Intervention Type BEHAVIORAL

surgery

children with anesthesia / surgery

anesthesia - surgery

Intervention Type BEHAVIORAL

Interventions

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anesthesia - surgery

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Psychiatrical, neurological, oncological diseases
Minimum Eligible Age

9 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Konstanze Plaschke

OTHER

Sponsor Role lead

Responsible Party

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Konstanze Plaschke

Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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S-086/2014

Identifier Type: -

Identifier Source: org_study_id

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