NCT07141797

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

January 14, 2026

Status Verified

December 1, 2025

Enrollment Period

Same day

First QC Date

July 2, 2025

Last Update Submit

January 13, 2026

Conditions

Keywords

general anesthesiachildrendeveloping brainexecutive functionscognitive assessment

Outcome Measures

Primary Outcomes (1)

  • 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).

    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

    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.

Study Arms (2)

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.

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.

Other: Executive functions assessment

Interventions

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.

Control groupGeneral anesthesia group

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Caen Normandie

Caen, Normandy, 14000, France

Location

MeSH Terms

Conditions

Neurodevelopmental DisordersChild Behavior Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2025

First Posted

August 26, 2025

Study Start

March 1, 2025

Primary Completion

March 1, 2025

Study Completion

November 1, 2025

Last Updated

January 14, 2026

Record last verified: 2025-12

Locations