NCT02658526

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

5 years

First QC Date

December 8, 2015

Last Update Submit

April 27, 2021

Conditions

Behavioral

Keywords

cognitionanesthesiasurgerystresschild

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (5)

  • surgery-associated data

    1 - 3 days

  • surgery-associated data

    1 day

  • surgery-associated data

    1 day

  • surgery-associated data

    1 day

  • surgery-associated data

    1 day

Study Arms (3)

control

children without anesthesia / surgery

anesthesia

children with anesthesia for diagnostic reason

Behavioral: anesthesia - surgery

surgery

children with anesthesia / surgery

Behavioral: anesthesia - surgery

Interventions

anesthesia - surgeryBEHAVIORAL
anesthesiasurgery

Eligibility Criteria

Age9 Months - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Cohort study - children \<3 years

You may qualify if:

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

You may not qualify if:

  • Psychiatrical, neurological, oncological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

MeSH Terms

Conditions

Behavior
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

December 8, 2015

First Posted

January 20, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)