BehavioralNCT02658526
Cognitive Changes in Childs After Anesthesia / Surgery
An observational study of Behavioral, run by Konstanze Plaschke at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 9 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral
- What is being tested?
- anesthesia - surgery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Cohort study - children <3 years
Who may be able to join
- Age 9 month to 3 years with or without anesthesia / surgery
Who cannot join
- Psychiatrical, neurological, oncological diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: 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.
Read the 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.
- Conditions
- Behavioral
- Being tested
- anesthesia - surgery
- Keywords
- cognition, anesthesia, surgery, stress, child
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesia - surgeryBehavioural
| Study group | Role | What they receive |
|---|---|---|
| control | children without anesthesia / surgery | |
| anesthesia | children with anesthesia for diagnostic reason Receives: Behavioral: anesthesia - surgery | |
| surgery | children with anesthesia / surgery Receives: Behavioral: anesthesia - surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cognitive abilities
Bayley Scale
Measured: 4-6 weeks
Global cognitive abilities
MONDEY (Milestone of Normal Development in Early Years) Scale
Measured: 4-6 weeks
Global cognitive abilities
Assessment of temperament with the Infant Behavior Questionnaire Revised (IBQ-R) questionnaire
Measured: 4-6 weeks
Global cognitive abilities
Early Childhood Behavior Questionnaire (ECBQ) questionnaire
Measured: 4-6 weeks
Secondary outcomes (5)
surgery-associated data
reason of surgery
Measured: 1 - 3 days
surgery-associated data
date of birth
Measured: 1 day
surgery-associated data
length of surgery (h:min)
Measured: 1 day
surgery-associated data
kind and quantity of anesthesia and medication (number)
Measured: 1 day
surgery-associated data
Age (month)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Problems in organization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehavioralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konstanze Plaschke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Konstanze Plaschke, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658526
- Sponsor's protocol ID
- S-086/2014
- Status last verified
- Apr 2021
- First submitted
- 8 Dec 2015
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Anesthesia / Surgery on Cognitive Function in Child
- ClinicalTrials.gov ID
- NCT02658526
- Acronym / sponsor ID
- S-086/2014
- Conditions
- Behavioral
- Keywords
- cognition, anesthesia, surgery, stress, child
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Problems in organization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Konstanze PlaschkeUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | – | –children without anesthesia / surgery |
| anesthesia | – | Behavioral: anesthesia - surgerychildren with anesthesia for diagnostic reason |
| surgery | – | Behavioral: anesthesia - surgerychildren with anesthesia / surgery |
Who may qualify
- Ages
- 9 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Cohort study - children <3 years
Key inclusion criteria (1 listed)
- Age 9 month to 3 years with or without anesthesia / surgery
Key exclusion criteria (1 listed)
- Psychiatrical, neurological, oncological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anesthesia - surgery | Behavioural | anesthesia, surgery |
Primary outcome
Global cognitive abilities
Time frame: 4-6 weeks
Bayley Scale
Global cognitive abilities
Time frame: 4-6 weeks
MONDEY (Milestone of Normal Development in Early Years) Scale
Global cognitive abilities
Time frame: 4-6 weeks
Assessment of temperament with the Infant Behavior Questionnaire Revised (IBQ-R) questionnaire
Global cognitive abilities
Time frame: 4-6 weeks
Early Childhood Behavior Questionnaire (ECBQ) questionnaire
5 secondary outcomes
surgery-associated data
Time frame: 1 - 3 days
surgery-associated data
Time frame: 1 day
surgery-associated data
Time frame: 1 day
surgery-associated data
Time frame: 1 day
surgery-associated data
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavioral, run by Konstanze Plaschke at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global cognitive abilities (time frame: 4-6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.