Cognitive Changes in Childs After Anesthesia / Surgery

April 27, 2021 updated by: Konstanze Plaschke

Role of Anesthesia / Surgery on Cognitive Function in Child

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Heidelberg, BW, Germany, 69120
        • University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cohort study - children <3 years

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Psychiatrical, neurological, oncological diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global cognitive abilities
Time Frame: 4-6 weeks
Bayley Scale
4-6 weeks
Global cognitive abilities
Time Frame: 4-6 weeks
MONDEY (Milestone of Normal Development in Early Years) Scale
4-6 weeks
Global cognitive abilities
Time Frame: 4-6 weeks
Assessment of temperament with the Infant Behavior Questionnaire Revised (IBQ-R) questionnaire
4-6 weeks
Global cognitive abilities
Time Frame: 4-6 weeks
Early Childhood Behavior Questionnaire (ECBQ) questionnaire
4-6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgery-associated data
Time Frame: 1 - 3 days
reason of surgery
1 - 3 days
surgery-associated data
Time Frame: 1 day
date of birth
1 day
surgery-associated data
Time Frame: 1 day
length of surgery (h:min)
1 day
surgery-associated data
Time Frame: 1 day
kind and quantity of anesthesia and medication (number)
1 day
surgery-associated data
Time Frame: 1 day
Age (month)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konstanze Plaschke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

December 8, 2015

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimate)

January 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-086/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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