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Problems in organization
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | children without anesthesia / surgery | ||
| anesthesia | children with anesthesia for diagnostic reason |
| |
| surgery | children with anesthesia / surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anesthesia - surgery | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global cognitive abilities | Bayley Scale | 4-6 weeks |
| Global cognitive abilities | MONDEY (Milestone of Normal Development in Early Years) Scale | 4-6 weeks |
| Global cognitive abilities | Assessment of temperament with the Infant Behavior Questionnaire Revised (IBQ-R) questionnaire | 4-6 weeks |
| Global cognitive abilities | Early Childhood Behavior Questionnaire (ECBQ) questionnaire | 4-6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| surgery-associated data | reason of surgery | 1 - 3 days |
| surgery-associated data | date of birth | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Cohort study - children <3 years
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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| surgery-associated data | length of surgery (h:min) | 1 day |
| surgery-associated data | kind and quantity of anesthesia and medication (number) | 1 day |
| surgery-associated data | Age (month) | 1 day |