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Cognitive Changes in Childs After Anesthesia / Surgery

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ClinicalTrials.gov Identifier: NCT02658526
Recruitment Status : Unknown
Verified October 2018 by Konstanze Plaschke, Heidelberg University.
Recruitment status was:  Recruiting
First Posted : January 20, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Konstanze Plaschke, Heidelberg University

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.

Condition or disease Intervention/treatment
Behavioral Behavioral: anesthesia - surgery

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.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Anesthesia / Surgery on Cognitive Function in Child
Study Start Date : December 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
control
children without anesthesia / surgery
anesthesia
children with anesthesia for diagnostic reason
Behavioral: anesthesia - surgery
surgery
children with anesthesia / surgery
Behavioral: anesthesia - surgery



Primary Outcome Measures :
  1. Global cognitive abilities [ Time Frame: 4-6 weeks ]
    Bayley Scale

  2. Global cognitive abilities [ Time Frame: 4-6 weeks ]
    MONDEY (Milestone of Normal Development in Early Years) Scale

  3. Global cognitive abilities [ Time Frame: 4-6 weeks ]
    Assessment of temperament with the Infant Behavior Questionnaire Revised (IBQ-R) questionnaire

  4. Global cognitive abilities [ Time Frame: 4-6 weeks ]
    Early Childhood Behavior Questionnaire (ECBQ) questionnaire


Secondary Outcome Measures :
  1. surgery-associated data [ Time Frame: 1 - 3 days ]
    reason of surgery

  2. surgery-associated data [ Time Frame: 1 day ]
    date of birth

  3. surgery-associated data [ Time Frame: 1 day ]
    length of surgery (h:min)

  4. surgery-associated data [ Time Frame: 1 day ]
    kind and quantity of anesthesia and medication (number)

  5. surgery-associated data [ Time Frame: 1 day ]
    Age (month)



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Ages Eligible for Study:   9 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Cohort study - children <3 years
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Psychiatrical, neurological, oncological diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658526


Locations
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Germany
University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School Recruiting
Heidelberg, BW, Germany, 69120
Contact: Christoph Schramm, MD    +49-6221-5638545    christoph.schramm@med.uni-heidelberg.de   
Principal Investigator: Konstanze Plaschke, Prof.         
Sponsors and Collaborators
Konstanze Plaschke
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Responsible Party: Konstanze Plaschke, Prof., Heidelberg University
ClinicalTrials.gov Identifier: NCT02658526    
Other Study ID Numbers: S-086/2014
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Konstanze Plaschke, Heidelberg University:
cognition
anesthesia
surgery
stress
child
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs