AnesthesiaGAPNCT04604106
General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics
An observational study of Anesthesia and Infant Development, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
This study investigates the impact of different levels of anesthesia exposure on children's neurocognitive development and evaluates the concurrent validity of different methods that assess neurodevelopmental outcome. Read more about this study
- Who is it for?
- Ages 11 to 13 monthsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Infant Development, Anesthesia; Adverse Effect
- What is being tested?
- Eyetracker, Ages & Stages questionnaire and Bayley Scale of Infant Development
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Oct 2020to Mar 2023
- 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 11 to 13 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: At the outpatient clinic of the department of pediatric surgery, children (< 12 months old) who are scheduled for or already underwent a single short, long or repetitive general anesthesia will be identified by the (fellow) pediatric surgeon. Parents/caretakers will be asked to participate in this study by the (fellow) surgeon who will ask informed consent. Healthy controls exist of eligible acquaintances and children that will be recruited via child health care centres by a member of the research team
Who may be able to join
- Age 12 months (± four weeks) with a history of general anesthesia exposure (patient group) or without a history of general anesthesia (healthy controls)
Who cannot join
- Children with comorbid conditions affecting structure and/or function of the central nervous system (e.g. premature birth) will be excluded from participation in this study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, locatie AMC
Amsterdam, North Holland, 1105AZ
J.P.M. Derikx, MD, PhD, +31205665693, j.derikx@amsterdamumc.nl
Jaap Oosterlaan, Prof.
About this study
This study investigates the impact of different levels of anesthesia exposure on children's neurocognitive development and evaluates the concurrent validity of different methods that assess neurodevelopmental outcome.
Read the detailed description
The US Food and Drug Administration (FDA) recently released an official warning regarding the potentially harmful impact of repeated and prolonged (more than three hours) general anesthesia on the child's brain. The potential impact of anesthesia highlights the importance of remediating the need for repeated and prolonged surgery with accompanying anesthesia exposure in a time of cerebral vulnerability and if possible, delay exposure to avoid potentially preventable harm. Therefore, it is crucial to better understand the impact of (different durations and frequencies of) anesthesia exposure on neurodevelopment.
- Conditions
- Anesthesia, Infant Development, Anesthesia; Adverse Effect
- Being tested
- Eyetracker, Ages & Stages questionnaire, Bayley Scale of Infant Development
- Keywords
- Anesthesiology, Neuropsychological test, Infant neurodevelopmental disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyetrackerDiagnostic test
Eye-tracking is an objective, non-invasive method and particularly suited to assess neurodevelopmental outcome in infants.
Ages & Stages questionnaireDiagnostic test
The Ages \& Stages Questionnaire is a conventional instrument used to measure developmental outcome in infants.
Bayley Scale of Infant DevelopmentDiagnostic test
The Bayley Scale of Infant Development is a conventional instrument used to measure developmental outcome in infants.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Infant aged 12 months (± four weeks) with a history of general anesthesia exposure Receives: Diagnostic Test: Eyetracker; Diagnostic Test: Ages & Stages questionnaire; Diagnostic Test: Bayley Scale of Infant Development | |
| Healthy subject group | Infant aged 12 months (± four weeks) without a history of general anesthesia Receives: Diagnostic Test: Eyetracker; Diagnostic Test: Ages & Stages questionnaire; Diagnostic Test: Bayley Scale of Infant Development |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive development as measured using eye-tracking metrics
Neurocognitive development as measured using eye-tracking metrics
Measured: At the age of 12 months (± four weeks)
Secondary outcomes (2)
Conventional measures of neurocognitive development (Ages & Stages Questionnaire and Bayley Scales of Infant Development )
Neurocognitive development as measured using the Ages \& Stages Questionnaire and Bayley Scales of Infant Development
Measured: At the age of 12 months (± four weeks)
Total anesthesia time.
Surgery and anesthesia time will be recorded by the (fellow) surgeon performing the operation(s). When multiple procedures are carried out, durations will be combined and these results will be retrieved during analysis of the data.
Measured: At the age of 12 months (± four weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start21 Oct 2020
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
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 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanne Maat, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- J.P.M. Derikx, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)J. Oosterlaan, Prof., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604106
- Sponsor's protocol ID
- NL71873.018.19
- Acronym
- GAP
- Status last verified
- Apr 2022
- First submitted
- 21 Oct 2020
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics
- ClinicalTrials.gov ID
- NCT04604106
- Acronym / sponsor ID
- GAP / NL71873.018.19
- Conditions
- Anesthesia, Infant Development, Anesthesia; Adverse Effect
- Keywords
- Anesthesiology, Neuropsychological test, Infant neurodevelopmental disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 27 Oct 2020 (actual)
- 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.
This study investigates the impact of different levels of anesthesia exposure on children's neurocognitive development and evaluates the concurrent validity of different methods that assess neurodevelopmental outcome.
Detailed description
The US Food and Drug Administration (FDA) recently released an official warning regarding the potentially harmful impact of repeated and prolonged (more than three hours) general anesthesia on the child's brain. The potential impact of anesthesia highlights the importance of remediating the need for repeated and prolonged surgery with accompanying anesthesia exposure in a time of cerebral vulnerability and if possible, delay exposure to avoid potentially preventable harm. Therefore, it is crucial to better understand the impact of (different durations and frequencies of) anesthesia exposure on neurodevelopment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Diagnostic Test: Eyetracker, Diagnostic Test: Ages & Stages questionnaire, Diagnostic Test: Bayley Scale of Infant DevelopmentInfant aged 12 months (± four weeks) with a history of general anesthesia exposure |
| Healthy subject group | – | Diagnostic Test: Eyetracker, Diagnostic Test: Ages & Stages questionnaire, Diagnostic Test: Bayley Scale of Infant DevelopmentInfant aged 12 months (± four weeks) without a history of general anesthesia |
Who may qualify
- Ages
- 11 to 13 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- At the outpatient clinic of the department of pediatric surgery, children (< 12 months old) who are scheduled for or already underwent a single short, long or repetitive general anesthesia will be identified by the (fellow) pediatric surgeon. Parents/caretakers will be asked to participate in this study by the (fellow) surgeon who will ask informed consent. Healthy controls exist of eligible acquaintances and children that will be recruited via child health care centres by a member of the research team
Key inclusion criteria (1 listed)
- Age 12 months (± four weeks) with a history of general anesthesia exposure (patient group) or without a history of general anesthesia (healthy controls)
Key exclusion criteria (1 listed)
- Children with comorbid conditions affecting structure and/or function of the central nervous system (e.g. premature birth) will be excluded from participation in this study.
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 |
|---|---|---|
| EyetrackerEye-tracking is an objective, non-invasive method and particularly suited to assess neurodevelopmental outcome in infants. | Diagnostic test | Healthy subject group, Patient group |
| Ages & Stages questionnaireThe Ages \& Stages Questionnaire is a conventional instrument used to measure developmental outcome in infants. | Diagnostic test | Healthy subject group, Patient group |
| Bayley Scale of Infant DevelopmentThe Bayley Scale of Infant Development is a conventional instrument used to measure developmental outcome in infants. | Diagnostic test | Healthy subject group, Patient group |
Primary outcome
Neurocognitive development as measured using eye-tracking metrics
Time frame: At the age of 12 months (± four weeks)
Neurocognitive development as measured using eye-tracking metrics
2 secondary outcomes
Conventional measures of neurocognitive development (Ages & Stages Questionnaire and Bayley Scales of Infant Development )
Time frame: At the age of 12 months (± four weeks)
Total anesthesia time.
Time frame: At the age of 12 months (± four weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: Yes
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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.
J.P.M. Derikx, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
J. Oosterlaan, Prof. principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 and Infant Development, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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: status not confirmed, as of the sponsor's last update on 11 Apr 2022. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanne Maat, MD (0031650100868, s.c.maat@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive development as measured using eye-tracking metrics (time frame: At the age of 12 months (± four weeks)). 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 11 Apr 2022.