AnesthesiaANFOLKI-36NCT03034889
Anesthesia Related Neurocognitive Deficits in Children
An observational study of Anesthesia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The infantile brain has to pass essential, mayor steps in the first 36 months of life. During that period of development it is particularly vulnerable to toxic, exogenic influences. This study wants to review the long-term effects of children who were exposed to anesthesia in the first three years of their life. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- How many people
- 700 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2017to Mar 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 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children age 4-10 who underwent general anesthesia below the age of 36 months in context of surgical or diagnostic procedures or sedation uring intensive care.
Who may be able to join
- General anesthesia before the age of 36 months
Who cannot join
- neurosurgical interventions
- cardiac surgery
- preexisting hereditary or acquired cognitive deficits
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurocognitive Development in Children Who Received General Anesthesia Before the Age of 3 Years: A Historic-prospective, Controlled, Single Center Cross-section Trial
The infantile brain has to pass essential, mayor steps in the first 36 months of life. During that period of development it is particularly vulnerable to toxic, exogenic influences. This study wants to review the long-term effects of children who were exposed to anesthesia in the first three years of their life. Therefore the investigators will examine children at age of 4-10 that were exposed to anesthesia and compare their neurocognitive capacity to children who did not have any exposure to anesthesia. The investigators plan on measuring the intelligence quotient using standardized tests which will be performed by a trained psychologist. In addition there will be a questionnaire concerning behavioral characteristics and educational development which is filled by the parents. The exposed children will be recruited from our preexisting database, the control group will be recruited from practitioners and the pediatric walk-in-clinic.
- Conditions
- Anesthesia
- Keywords
- Anesthesia, Children, General Anesthesia, Neurocognitive Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Children age 4-10 who required general anesthesia before the age of 36 months in the context of surgical and diagnostic procedures or sedation during intensive care, excluding neurosurgical interventions or cardiac surgery as well as preexisting hereditary or acquired neurocognitive deficits | |
| Control | Children age 4-10 who did not require any anesthesia before the age of 36 months. Excluding preexisting hereditary or acquired neurocognitive deficits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Capacity for children between 7 and 10 years of age
Standardized tests for intelligence quotient (IQ): Kaufman Assessment Battery for Children - Second Edition (KABC-II)
Measured: Test is done 1 to 10 years after anesthesia and is lasting 3 hours
Cognitive Capacity for children between 4 and 7 years of age
Standardized tests for intelligence quotient (IQ): Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III)
Measured: Test is done 1 to 10 years after anesthesia and is lasting 3 hours
Cognitive Capacity for children between 2 and 4 years of age
Standardized tests for intelligence quotient (IQ): Wechsler Intelligence Scale for Children (WISC-IV)
Measured: Test is done 1 to 10 years after anesthesia and is lasting 3 hours
Secondary outcomes (1)
Educational status
Questionnaire, filled by parents 1-10 years after anesthesia exposure
Measured: 1 to 10 years after anesthesia, lasting 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2019
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tino Münster, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034889
- Sponsor's protocol ID
- ANFOLKI-36
- Acronym
- ANFOLKI-36
- Status last verified
- Mar 2020
- First submitted
- 23 Jan 2017
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Development in Children Who Received General Anesthesia Before the Age of 3 Years: A Historic-prospective, Controlled, Single Center Cross-section Trial
- ClinicalTrials.gov ID
- NCT03034889
- Acronym / sponsor ID
- ANFOLKI-36 / ANFOLKI-36
- Conditions
- Anesthesia
- Keywords
- Anesthesia, Children, General Anesthesia, Neurocognitive Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 27 Jan 2017 (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 infantile brain has to pass essential, mayor steps in the first 36 months of life. During that period of development it is particularly vulnerable to toxic, exogenic influences. This study wants to review the long-term effects of children who were exposed to anesthesia in the first three years of their life. Therefore the investigators will examine children at age of 4-10 that were exposed to anesthesia and compare their neurocognitive capacity to children who did not have any exposure to anesthesia. The investigators plan on measuring the intelligence quotient using standardized tests which will be performed by a trained psychologist. In addition there will be a questionnaire concerning behavioral characteristics and educational development which is filled by the parents. The exposed children will be recruited from our preexisting database, the control group will be recruited from practitioners and the pediatric walk-in-clinic.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | –Children age 4-10 who required general anesthesia before the age of 36 months in the context of surgical and diagnostic procedures or sedation during intensive care, excluding neurosurgical interventions or cardiac surgery as well as preexisting hereditary or acquired neurocognitive deficits |
| Control | – | –Children age 4-10 who did not require any anesthesia before the age of 36 months. Excluding preexisting hereditary or acquired neurocognitive deficits. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children age 4-10 who underwent general anesthesia below the age of 36 months in context of surgical or diagnostic procedures or sedation uring intensive care.
Key inclusion criteria (1 listed)
- General anesthesia before the age of 36 months
Key exclusion criteria (4 listed)
- neurosurgical interventions
- cardiac surgery
- preexisting hereditary or acquired cognitive deficits
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive Capacity for children between 7 and 10 years of age
Time frame: Test is done 1 to 10 years after anesthesia and is lasting 3 hours
Standardized tests for intelligence quotient (IQ): Kaufman Assessment Battery for Children - Second Edition (KABC-II)
Cognitive Capacity for children between 4 and 7 years of age
Time frame: Test is done 1 to 10 years after anesthesia and is lasting 3 hours
Standardized tests for intelligence quotient (IQ): Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III)
Cognitive Capacity for children between 2 and 4 years of age
Time frame: Test is done 1 to 10 years after anesthesia and is lasting 3 hours
Standardized tests for intelligence quotient (IQ): Wechsler Intelligence Scale for Children (WISC-IV)
1 secondary outcome
Educational status
Time frame: 1 to 10 years after anesthesia, lasting 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
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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 Anesthesia, run by University of Erlangen-Nürnberg Medical School 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 4 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: finished, as of the sponsor's last update on 24 Mar 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive Capacity for children between 7 and 10 years of age (time frame: Test is done 1 to 10 years after anesthesia and is lasting 3 hours). The study lists 3 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 24 Mar 2020.