Neurodevelopmental DisordersNCT07141797
Impact of General Anesthesia in Childhood on Cognitive Processes
An observational study of Neurodevelopmental Disorders and Child Behavior Disorders, run by University Hospital, Caen at 1 site in France.
Trial summary
This study aims to evaluate the potential long-term cognitive effects of general anesthesia administered before the age of 4. Specifically, it investigates executive functions-including inhibition, working memory, and cognitive flexibility-in children aged 9 to 10 years. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders, Child Behavior Disorders
- What is being tested?
- Executive functions assessment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2025to 1 Nov 2025
- How long will I take part?
- 1 Day
- 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 9-10 years, attending school, who have either been exposed or not exposed to general anesthesia for a functional surgery before the age of 4.
Who may be able to join
- Children aged 9-10 years Mainstream class (non-specialized) Requirement for information on the right to object Requirement for affiliation with social security French-speaking
Who cannot join
- Criteria for "Parents" Parental refusal Twins Exposure to general anesthesia during pregnancy, including cesarean section under general anesthesia
- Pregnancy-related pathology:
- Pregnancy-induced hypertension
- Preeclampsia
- Gestational diabetes
- Threat of preterm labor
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- Depressive syndrome
- Chronic treatment during pregnancy:
- Pregnancy-induced hypertension: antihypertensive treatment (beta-blockers, calcium channel blockers)
- Preeclampsia: antihypertensive treatment (beta-blockers, calcium channel blockers), magnesium sulfate
- Gestational diabetes: dietary regimen, insulin
- Threat of preterm labor: prenatal corticosteroid therapy, magnesium sulfate
- Depressive syndrome: antidepressant psychotropic treatment Smoking during pregnancy, alcohol consumption during pregnancy, drug use during pregnancy Criteria for "Children" Child refusal to participate in the study Premature birth (i.e., before 37 weeks of gestation) Evolving or chronic psychiatric pathology, whether or not requiring chronic treatment Evolving or chronic neurological or neuromuscular pathology Genetic pathology Any chronic pathology requiring specialized follow-up and/or treatment (doctor, psychologist, speech therapist) Specialized neuro-pediatric or pediatric psychiatric follow-up, or follow-up with a psychologist or speech therapist during childhood Neuro-visual disorders (excluding normal vision with correction) Hearing disorders, whether or not using hearing aids Chronic otorhinolaryngological pathology, including sleep apnea syndrome, with or without apparatus Developmental disorders: ADHD, autism, or other, whether or not requiring chronic treatment Pediatric intensive care hospitalization Conventional hospitalization for more than 1 week during childhood Child who underwent multiple general anesthesias before the age of 4
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the potential long-term cognitive effects of general anesthesia administered before the age of 4. Specifically, it investigates executive functions-including inhibition, working memory, and cognitive flexibility-in children aged 9 to 10 years. A secondary objective assesses visuo-spatial attention.
Participants will be divided into two groups: (1) children exposed to a single general anesthesia for functional surgery before age 4, and (2) a control group with no such exposure. Cognitive performance will be assessed through computerized tasks with time constraints, conducted in a school setting. The study is designed to compare these groups prospectively in order to determine whether early exposure to general anesthesia is associated with differences in cognitive functioning at school age.
Read the detailed description
This study investigates the long-term cognitive effects of early exposure to general anesthesia in children. Specifically, it focuses on evaluating executive functions-namely inhibition, working memory, and cognitive flexibility-in children aged 9-10 years who underwent functional surgery with general anesthesia before age 4. A secondary objective includes assessing visuo-spatial attention and general intelligence.
Executive functions will be measured using standardized, computerized tasks. Inhibition will be assessed through both an emotional Stroop (hot inhibition) and a classic Stroop task (cold inhibition). Working memory will be evaluated using a spatial sequence recall task on a grid, in both forward and reverse order. Flexibility will be measured through an adapted version of the computerized Trail Making Test, requiring rule-switching between tasks based on stimulus color.
Visuo-spatial abilities will be assessed using a global-local task involving hierarchical visual stimuli, allowing for evaluation of attention to detail versus overall structure. General intelligence will be measured using Raven's Progressive Matrices.
Participants will be recruited from selected elementary schools in partnership with local educational authorities. Eligible children will be grouped based on prior exposure to general anesthesia, matched on age, sex, and socio-economic status. Testing will occur in school settings during class time under controlled, blinded conditions. Data will be anonymized and processed in accordance with GDPR standards. Statistical analyses will include MANOVA and linear models to assess group differences.
- Being tested
- Executive functions assessment
- Keywords
- general anesthesia, children, developing brain, executive functions, cognitive assessment
- Medical subject headings
- Neurodevelopmental Disorders, Child Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Executive functions assessmentOther
Inhibition: Emotional (hot) and logical (cold) inhibition using Emotional and Classic Stroop tests. Participants identify the color of words or emotion in photos while inhibiting automatic responses. Inhibition scores are based on the difference in response times between congruent and interference conditions.
Working Memory: Participants recall a sequence of points on a grid, first in the original order, then in reverse. The working memory score is the difference between the two tasks.
Cognitive Flexibility: A task requiring alternation between identifying numbers as greater/less than 5 or even/odd based on color cues. Flexibility is scored by comparing response times for alternating and non-alternating tasks.
Visuospatial abilities are assessed with a global-local task. Raven's Progressive Matrices will assess general intelligence, and socio-economic data will be collected.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia group | Children aged 9 or 10 at the time of the study, who were exposed to a single general anesthesia for a functional surgery during childhood before the age of 4. Receives: Other: Executive functions assessment | |
| Control group | Children aged 9 or 10 at the time of the study, who were not exposed to general anesthesia for surgery during childhood. Receives: Other: Executive functions assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition/ working memory/ flexibility
Cold Inhibition: Measured by the Stroop task (color-word interference). Unit: reaction time difference (ms).
Hot Inhibition: Measured by the emotional Stroop (faces and emotional words). Unit: reaction time difference (ms).
Working Memory: Assessed via forward and backward spatial recall on a grid. Unit: number of correct sequences.
Cognitive Flexibility: Measured by a rule-switching task (digit color cues: magnitude vs. parity). Flexibility is the RT difference between switch and control tasks. Unit: reaction time difference (ms).
Measured: Day 1 (single school testing session). The assessment of all judgment criteria is conducted during a 30-minute timed testing session on a computer, with the child present.
Secondary outcomes (1)
Visuo-spatial abilities/ measure of general intelligence
Visuo-spatial abilities will be assessed using a global-local task, where participants identify shapes (square or circle) at either the global or local level, based on hierarchical stimuli. This evaluates attentional processing of visual details vs. overall structure. A general intelligence test will also be administered to ensure group equivalence.
Measured: Day 1 (single school testing session). The assessment of all judgment criteria is conducted during a 30-minute timed testing session on a computer, with the child present.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141797
- Sponsor's protocol ID
- 2023-A00110-83
- Status last verified
- Dec 2025
- First submitted
- 2 Jul 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of General Anesthesia in Childhood on Cognitive Processes
- ClinicalTrials.gov ID
- NCT07141797
- Acronym / sponsor ID
- 2023-A00110-83
- Keywords
- general anesthesia, children, developing brain, executive functions, cognitive assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 26 Aug 2025 (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 aims to evaluate the potential long-term cognitive effects of general anesthesia administered before the age of 4. Specifically, it investigates executive functions-including inhibition, working memory, and cognitive flexibility-in children aged 9 to 10 years. A secondary objective assesses visuo-spatial attention.
Participants will be divided into two groups: (1) children exposed to a single general anesthesia for functional surgery before age 4, and (2) a control group with no such exposure. Cognitive performance will be assessed through computerized tasks with time constraints, conducted in a school setting. The study is designed to compare these groups prospectively in order to determine whether early exposure to general anesthesia is associated with differences in cognitive functioning at school age.
Detailed description
This study investigates the long-term cognitive effects of early exposure to general anesthesia in children. Specifically, it focuses on evaluating executive functions-namely inhibition, working memory, and cognitive flexibility-in children aged 9-10 years who underwent functional surgery with general anesthesia before age 4. A secondary objective includes assessing visuo-spatial attention and general intelligence.
Executive functions will be measured using standardized, computerized tasks. Inhibition will be assessed through both an emotional Stroop (hot inhibition) and a classic Stroop task (cold inhibition). Working memory will be evaluated using a spatial sequence recall task on a grid, in both forward and reverse order. Flexibility will be measured through an adapted version of the computerized Trail Making Test, requiring rule-switching between tasks based on stimulus color.
Visuo-spatial abilities will be assessed using a global-local task involving hierarchical visual stimuli, allowing for evaluation of attention to detail versus overall structure. General intelligence will be measured using Raven's Progressive Matrices.
Participants will be recruited from selected elementary schools in partnership with local educational authorities. Eligible children will be grouped based on prior exposure to general anesthesia, matched on age, sex, and socio-economic status. Testing will occur in school settings during class time under controlled, blinded conditions. Data will be anonymized and processed in accordance with GDPR standards. Statistical analyses will include MANOVA and linear models to assess group differences.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia group | – | Other: Executive functions assessmentChildren aged 9 or 10 at the time of the study, who were exposed to a single general anesthesia for a functional surgery during childhood before the age of 4. |
| Control group | – | Other: Executive functions assessmentChildren aged 9 or 10 at the time of the study, who were not exposed to general anesthesia for surgery during childhood. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 9-10 years, attending school, who have either been exposed or not exposed to general anesthesia for a functional surgery before the age of 4.
Key inclusion criteria (1 listed)
- Children aged 9-10 years Mainstream class (non-specialized) Requirement for information on the right to object Requirement for affiliation with social security French-speaking
Key exclusion criteria (13 listed)
- Criteria for "Parents" Parental refusal Twins Exposure to general anesthesia during pregnancy, including cesarean section under general anesthesia
- Pregnancy-induced hypertension
- Preeclampsia
- Gestational diabetes
- Threat of preterm labor
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 |
|---|---|---|
| Executive functions assessmentInhibition: Emotional (hot) and logical (cold) inhibition using Emotional and Classic Stroop tests. Participants identify the color of words or emotion in photos while inhibiting automatic responses. Inhibition scores are based on the difference in response times between congruent and interference conditions. Working Memory: Participants recall a sequence of points on a grid, first in the original order, then in reverse. The working memory score is the difference between the two tasks. Cognitive Flexibility: A task requiring alternation between identifying numbers as greater/less than 5 or even/odd based on color cues. Flexibility is scored by comparing response times for alternating and non-alternating tasks. Visuospatial abilities are assessed with a global-local task. Raven's Progressive Matrices will assess general intelligence, and socio-economic data will be collected. | Other | Control group, General anesthesia group |
Primary outcome
Inhibition/ working memory/ flexibility
Time frame: Day 1 (single school testing session). The assessment of all judgment criteria is conducted during a 30-minute timed testing session on a computer, with the child present.
Cold Inhibition: Measured by the Stroop task (color-word interference). Unit: reaction time difference (ms). Hot Inhibition: Measured by the emotional Stroop (faces and emotional words). Unit: reaction time difference (ms). Working Memory: Assessed via forward and backward spatial recall on a grid. Unit: number of correct sequences. Cognitive Flexibility: Measured by a rule-switching task (digit color cues: magnitude vs. parity). Flexibility is the RT difference between switch and control tasks. Unit: reaction time difference (ms).
1 secondary outcome
Visuo-spatial abilities/ measure of general intelligence
Time frame: Day 1 (single school testing session). The assessment of all judgment criteria is conducted during a 30-minute timed testing session on a computer, with the child present.
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 14 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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 Neurodevelopmental Disorders and Child Behavior Disorders, run by University Hospital, Caen at 1 site in France.
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 13 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 14 Jan 2026. 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 France. 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?
Inhibition/ working memory/ flexibility (time frame: Day 1 (single school testing session). The assessment of all judgment criteria is conducted during a 30-minute timed testing session on a computer, with the child present.). 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 14 Jan 2026.