Cognitive Changes in Childs After Anesthesia / Surgery

Behavioral Clinical Trial

Official title:

Role of Anesthesia / Surgery on Cognitive Function in Child

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02658526
• Other study ID #: S-086/2014
• Status: Withdrawn
• Start date: December 2015
• Est. completion date: December 2020

Study information

• Verified date: April 2021
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 3 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Psychiatrical, neurological, oncological diseases

Related Conditions & MeSH terms

• Behavioral

Intervention

Behavioral:
• anesthesia - surgery

Locations

Country	Name	City	State
Germany	University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School	Heidelberg	BW

Sponsors (1)

Lead Sponsor	Collaborator
Konstanze Plaschke

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global cognitive abilities	Bayley Scale	4-6 weeks
Primary	Global cognitive abilities	MONDEY (Milestone of Normal Development in Early Years) Scale	4-6 weeks
Primary	Global cognitive abilities	Assessment of temperament with the Infant Behavior Questionnaire Revised (IBQ-R) questionnaire	4-6 weeks
Primary	Global cognitive abilities	Early Childhood Behavior Questionnaire (ECBQ) questionnaire	4-6 weeks
Secondary	surgery-associated data	reason of surgery	1 - 3 days
Secondary	surgery-associated data	date of birth	1 day
Secondary	surgery-associated data	length of surgery (h:min)	1 day
Secondary	surgery-associated data	kind and quantity of anesthesia and medication (number)	1 day
Secondary	surgery-associated data	Age (month)	1 day