Neurodevelopmental DisordersNCT06052878
Neurodevelopmental Outcome After Prenatal Anesthesia
An observational study of Neurodevelopmental Disorders and Child Behavior, run by University Hospital, Caen at 1 site in France.
Trial summary
In 2016, the US Food and Drug Administration raised concerns about the potential negative effects of anesthesia exposure on neurodevelopment in children during pregnancy or before the age of three. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders, Child Behavior
- What is being tested?
- Parental telephone interview with standardized parental questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF) and Parental questionnaire about their child's cognitive functioning in their daily life and medical history.
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2023to 26 Feb 2024
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children born between 2011 and 2018 at Caen University Hospital : * Whose mothers underwent general anesthesia for non-obstetric surgery during pregnancy (the "general anesthesia" group). * Whose mothers underwent locoregional anesthesia for non-obstetric surgery during pregnancy (the "locoregional anesthesia" group). * Whose mothers who did not undergo any surgical intervention during pregnancy (the "control" group).
Who may be able to join
- Children born between 2011 and 2018 at Caen University Hospital
- Children whose mothers underwent surgery for non-obstetrical reasons under general or locoregional anesthesia, or did not undergo any surgical intervention.
Who cannot join
- Lost to follow-up
- Incomplete medical files
- Refusal of either parent or legal guardian
- Children with condition presenting independent risk factors for impaired neurocognitive development such as : neonatal hypoxia-ischemia, neurological disorder, neuromuscular disorder, complex cardiac or genetic disorders
- Children with a known or suspected genetic syndrome
- Preterm-born children (defined as birth at less than 37 weeks of amenorrhea)
- Cesarean-born children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Prenatal Anesthesia Exposure and Neurodevelopmental Outcome : an Ambi-directional Cohort Study
In 2016, the US Food and Drug Administration raised concerns about the potential negative effects of anesthesia exposure on neurodevelopment in children during pregnancy or before the age of three.
The impact of exposure to anesthetic agents on neurodevelopmental outcome however remains debated: clinical studies on the subject do not allow for unequivocal conclusions to be drawn, given their methodological heterogeneity and the numerous confounding environmental factors.
Read more
To this date, only two studies have focused on the potential neurodevelopmental effects of general anesthesia during the prenatal period, even though general anesthesia for non-obstetric surgery during pregnancy affects up to 3% of pregnant women.
This observational ambidirectional study would be the first to investigate the potential neurodevelopmental effects of prenatal exposure to anesthesia, whether general or regional, for surgery during pregnancy. It would thus differentiate between the contribution of surgical stress and that of anesthetic agents in any observed modifications.
The aim of the study is:
Are there any subtle modifications of executive functions associated with prenatal exposure to anesthesia during non-obstetric surgery during pregnancy?
To investigate this, parents of the participating children will be asked to complete a standardized parental telephone questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF). This parental questionnaire allows for evaluating children's behaviors related to executive functions.
Researchers will compare the score derived from the "BRIEF" parental questionnaire (BRIEF score) between three groups of children aged from 5 to 12 years old, born between 2011 and 2018 at Caen University Hospital:
- The " General anesthesia " group: children whose mothers underwent general anesthesia for non-obstetric surgery during pregnancy (N: 62).
- The " Locoregional anesthesia " group: children whose mothers underwent regional anesthesia for non-obstetric surgery during pregnancy (N: 31).
- The " Control " group: children whose mothers did not undergo any surgical intervention during pregnancy (N: 62).
The first aim of our study is to investigate the presence of a significant difference in the BRIEF score between the three groups.
The seconds aims are to assess the cognitive functioning of patients in their daily lives (school, parental home, and extracurricular activities).
Read the detailed description
The study : "Association Between Prenatal Anesthesia Exposure and Neurodevelopmental Outcome : an Ambidirectional Cohort Study" is a single-center, ambidirectional, observational cohort study conducted at the University Hospital Center of Caen (CHU Caen).
Inclusion criteria :
The study groups "General Anesthesia" (GA group) and "Locoregional Anesthesia" (LRA group) are derived from a previous Caen University Hospital cohort, consisting of children whose mothers underwent general or regional anesthesia for non-obstetric surgery during pregnancy.
This previous cohort was established in 2021 for an unpublished research project consisting of 179 patients who underwent non-obstetric surgeries during pregnancy. These pregnant women who underwent surgery were identified through the Caen University hospital electronic database spanning from 2011 to 2020, as surgical procedures for pregnant women started to be documented since 2011 in the medical database of this hospital.
The "control group" will be formed by including children born at Caen University Hospital, the same day, right before and right after the children in the LRA group, but whose mothers did not undergo any surgical intervention during pregnancy.
The number of exposed patients (N=93) is comparable to prospective studies investigating the effect of postnatal general anesthesia on neurodevelopmental outcomes. It is also comparable to and higher than the two studies investigating the effect of prenatal general anesthesia on neurodevelopmental outcomes.
Matching :
The matching of the GA and LRA groups will be done based on the following three adjustment factors:
- Socio-economic level (parental monthly net income within a range of 500 euros)
- Age at the time of testing
- Gender of the child
Inclusion process:
After providing the information sheet and receiving the signed consent form from the legal guardian of the child, the elements of the parental telephone interview will be collected from the child's parents, prospectively, on a standardized data collection sheet during an estimated phone call duration of approximately forty minutes.
The phone call will consist of two parts :
- The standardized parental questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF).
- The parental hetero-questionnaire about their child's cognitive functioning in their daily life and medical history.
Both the parental standardized BRIEF questionnaire and our parental hetero-questionnaire will contribute to fulfilling the study objectives.
The parental hetero-questionnaire is the result of a discussion between clinicians specialized in pediatric and obstetric anesthesia and researchers specialized in the neurocognitive development of children.
Several anamnestic data from the medical records of the patients and their child such as progress of pregnancy, childbirth history, history of general anesthesia during childhood, hospitalization during childhood,, will also be collected retrospectively on a standardized data collection sheet.
Statistical Methodology:
The number of subjects included in the Caen University Hospital cohort comprises : 31 patients in the "locoregional anesthesia" (LRA) group with a 1:2 matching with the "general anesthesia" (GA) group, resulting in 62 patients.
The "control" group is also matched with a 1:2 ratio with the "LRA" group, resulting in 62 patients.
The significance level is set at 5%. Data will be collected using Excel 2022 software (Microsoft Corporation, Redmond, WA, USA). Discrete variables will be expressed as number of cases (%). Continuous variables will be presented as mean ± standard deviations for normally distributed data or as median (95% confidence interval) for non-normally distributed data.
The statistical software used will be Statistica 12, Statsoft®.
Data Management:
The data will be entered into a spreadsheet for statistical analysis of the collected values. These data will only be used for this study, and the sponsor undertakes not to disclose them to third parties. The data processing will comply with the General Data Protection Regulation (GDPR) guidelines.
- Conditions
- Neurodevelopmental Disorders, Child Behavior
- Being tested
- Parental telephone interview with standardized parental questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF), Parental questionnaire about their child's cognitive functioning in their daily life and medical history.
- Keywords
- general anesthesia, regional anesthesia, pregnancy, executive functions, developing brain, neurodevelopment, surgery
- Medical subject headings
- Neurodevelopmental Disorders, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental telephone interview with standardized parental questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF)Other
The "Behaviour Rating Inventory of Executive Function" (BRIEF) is a parental questionnaire that assesses the executive functions of children aged 5 to 18 years old. It consists of 86 questions grouped into 8 scales: inhibition, flexibility, emotional control, initiation, material organization, working memory, planning/organization, and monitoring. It provides information on a global scale (score) regarding subtle and subclinical changes in various executive functions.
Parental questionnaire about their child's cognitive functioning in their daily life and medical history.Other
Standardized questionnaire includes : The child's medical history and cognitive functioning (at school, parental home, and during extracurricular activities), home environment, parent's child socioeconomic status and emotional climate.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Children whose mothers underwent general anesthesia for non-obstetric surgery during pregnancy. Receives: Other: Parental telephone interview with standardized parental questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF); Other: Parental questionnaire about their child's cognitive functioning in their daily life and medical history. | |
| Locoregional anesthesia | Children whose mothers underwent regional anesthesia for non-obstetric surgery during pregnancy. Receives: Other: Parental telephone interview with standardized parental questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF); Other: Parental questionnaire about their child's cognitive functioning in their daily life and medical history. | |
| Control | Children whose mothers did not undergo any surgical intervention during pregnancy. Receives: Other: Parental telephone interview with standardized parental questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF); Other: Parental questionnaire about their child's cognitive functioning in their daily life and medical history. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The "Behavior Rating Inventory of Executive Function" composite score
The "Behaviour Rating Inventory of Executive Function" (BRIEF) is a parental questionnaire that assesses the executive functions of children aged 5 to 18 years old. It consists of 86 questions grouped into 8 scales: inhibition, flexibility, emotional control, initiation, material organization, working memory, planning/organization, and monitoring. It provides information on a global scale (score) regarding subtle and subclinical changes in various executive functions
Measured: Through the fourty minute phone call to the child's legal guardian. All phone calls will be conducted during the course of the study, which lasts an average of 2 months."
Secondary outcomes (1)
The child's cognitif functioning (at school, parental home, and during extracurricular activities), and medical history.
Progress of pregnancy, history of general anesthesia during childhood, hospitalization during childhood, non-febrile seizure during childhood, history of chronic otolaryngological pathology, specialized neuro-pediatric or child psychiatry follow-up, psychological or speech therapy in childhood, use of psychotropic medication, occasional psychological consultation, Psychological follow-up in childhood, speech therapy follow-up, diagnosed developmental disorder, reported school delay, school difficulties reported by teachers, specialized class or institution, experience of traumatic life events (bullying, death of a loved one), child's well-being in daily life: at school, at home, engagement in extracurricular activities and child's well-being, amount of screen time
Measured: Through the fourty minute phone call to the child's legal guardian. All phone calls will be conducted the course during of the study, which lasts an average of 2 months."
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start9 Oct 2023
- Primary completion23 Feb 2024
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies 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
- Other
- Enrolment
- 106 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Salaün, MD PhD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052878
- Sponsor's protocol ID
- CHUCaen
- Status last verified
- Mar 2024
- First submitted
- 14 Jun 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Salaun JP, Chagnot A, Cachia A, Poirel N, Datin-Dorriere V, Dujarrier C, Lemarchand E, Rolland M, Delalande L, Gressens P, Guillois B, Houde O, Levard D, Gakuba C, Moyon M, Naveau M, Orliac F, Orliaguet G, Hanouz JL, Agin V, Borst G, Vivien D. Consequences of General Anesthesia in Infancy on Behavior and Brain Structure. Anesth Analg. 2023 Feb 1;136(2):240-250. doi: 10.1213/ANE.0000000000006233. Epub 2022 Oct 27.
PubMed 36638508Bleeser T, Devroe S, Lucas N, Debels T, Van de Velde M, Lemiere J, Deprest J, Rex S. Neurodevelopmental outcomes after prenatal exposure to anaesthesia for maternal surgery: a propensity-score weighted bidirectional cohort study. Anaesthesia. 2023 Feb;78(2):159-169. doi: 10.1111/anae.15884. Epub 2022 Oct 25.
PubMed 36283123Shi Y, Hu D, Rodgers EL, Katusic SK, Gleich SJ, Hanson AC, Schroeder DR, Flick RP, Warner DO. Epidemiology of general anesthesia prior to age 3 in a population-based birth cohort. Paediatr Anaesth. 2018 Jun;28(6):513-519. doi: 10.1111/pan.13359. Epub 2018 Mar 13.
PubMed 29532559Marchesini V, Disma N. Anaesthetic neuroprotection in children: does it exist or is it all just bad? Curr Opin Anaesthesiol. 2019 Jun;32(3):363-369. doi: 10.1097/ACO.0000000000000723.
PubMed 30893117Paule MG, Li M, Allen RR, Liu F, Zou X, Hotchkiss C, Hanig JP, Patterson TA, Slikker W Jr, Wang C. Ketamine anesthesia during the first week of life can cause long-lasting cognitive deficits in rhesus monkeys. Neurotoxicol Teratol. 2011 Mar-Apr;33(2):220-30. doi: 10.1016/j.ntt.2011.01.001. Epub 2011 Jan 15.
PubMed 21241795Andropoulos DB, Greene MF. Anesthesia and Developing Brains - Implications of the FDA Warning. N Engl J Med. 2017 Mar 9;376(10):905-907. doi: 10.1056/NEJMp1700196. Epub 2017 Feb 8. No abstract available.
PubMed 28177852Walkden GJ, Gill H, Davies NM, Peters AE, Wright I, Pickering AE. Early Childhood General Anesthesia and Neurodevelopmental Outcomes in the Avon Longitudinal Study of Parents and Children Birth Cohort. Anesthesiology. 2020 Nov 1;133(5):1007-1020. doi: 10.1097/ALN.0000000000003522.
PubMed 32898216Sun LS, Li G, Miller TL, Salorio C, Byrne MW, Bellinger DC, Ing C, Park R, Radcliffe J, Hays SR, DiMaggio CJ, Cooper TJ, Rauh V, Maxwell LG, Youn A, McGowan FX. Association Between a Single General Anesthesia Exposure Before Age 36 Months and Neurocognitive Outcomes in Later Childhood. JAMA. 2016 Jun 7;315(21):2312-20. doi: 10.1001/jama.2016.6967.
PubMed 27272582Warner DO, Zaccariello MJ, Katusic SK, Schroeder DR, Hanson AC, Schulte PJ, Buenvenida SL, Gleich SJ, Wilder RT, Sprung J, Hu D, Voigt RG, Paule MG, Chelonis JJ, Flick RP. Neuropsychological and Behavioral Outcomes after Exposure of Young Children to Procedures Requiring General Anesthesia: The Mayo Anesthesia Safety in Kids (MASK) Study. Anesthesiology. 2018 Jul;129(1):89-105. doi: 10.1097/ALN.0000000000002232.
PubMed 29672337Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, Stargatt R, Bellinger DC, Schuster T, Arnup SJ, Hardy P, Hunt RW, Takagi MJ, Giribaldi G, Hartmann PL, Salvo I, Morton NS, von Ungern Sternberg BS, Locatelli BG, Wilton N, Lynn A, Thomas JJ, Polaner D, Bagshaw O, Szmuk P, Absalom AR, Frawley G, Berde C, Ormond GD, Marmor J, McCann ME; GAS consortium. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. Lancet. 2016 Jan 16;387(10015):239-50. doi: 10.1016/S0140-6736(15)00608-X. Epub 2015 Nov 4.
PubMed 26507180McCann ME, de Graaff JC, Dorris L, Disma N, Withington D, Bell G, Grobler A, Stargatt R, Hunt RW, Sheppard SJ, Marmor J, Giribaldi G, Bellinger DC, Hartmann PL, Hardy P, Frawley G, Izzo F, von Ungern Sternberg BS, Lynn A, Wilton N, Mueller M, Polaner DM, Absalom AR, Szmuk P, Morton N, Berde C, Soriano S, Davidson AJ; GAS Consortium. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial. Lancet. 2019 Feb 16;393(10172):664-677. doi: 10.1016/S0140-6736(18)32485-1. Epub 2019 Feb 14.
PubMed 30782342DiMaggio C, Sun LS, Li G. Early childhood exposure to anesthesia and risk of developmental and behavioral disorders in a sibling birth cohort. Anesth Analg. 2011 Nov;113(5):1143-51. doi: 10.1213/ANE.0b013e3182147f42. Epub 2011 Mar 17.
PubMed 21415431Zhang H, Du L, Du Z, Jiang H, Han D, Li Q. Association between childhood exposure to single general anesthesia and neurodevelopment: a systematic review and meta-analysis of cohort study. J Anesth. 2015 Oct;29(5):749-57. doi: 10.1007/s00540-015-2030-z. Epub 2015 May 23.
PubMed 26002228Clausen NG, Kahler S, Hansen TG. Systematic review of the neurocognitive outcomes used in studies of paediatric anaesthesia neurotoxicity. Br J Anaesth. 2018 Jun;120(6):1255-1273. doi: 10.1016/j.bja.2017.11.107. Epub 2018 Feb 3.
PubMed 29793593Walkden GJ, Pickering AE, Gill H. Assessing Long-term Neurodevelopmental Outcome Following General Anesthesia in Early Childhood: Challenges and Opportunities. Anesth Analg. 2019 Apr;128(4):681-694. doi: 10.1213/ANE.0000000000004052.
PubMed 30883414
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Prenatal Anesthesia Exposure and Neurodevelopmental Outcome : an Ambi-directional Cohort Study
- ClinicalTrials.gov ID
- NCT06052878
- Acronym / sponsor ID
- CHUCaen
- Conditions
- Neurodevelopmental Disorders, Child Behavior
- Keywords
- general anesthesia, regional anesthesia, pregnancy, executive functions, developing brain, neurodevelopment, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 25 Sep 2023 (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.
In 2016, the US Food and Drug Administration raised concerns about the potential negative effects of anesthesia exposure on neurodevelopment in children during pregnancy or before the age of three.
The impact of exposure to anesthetic agents on neurodevelopmental outcome however remains debated: clinical studies on the subject do not allow for unequivocal conclusions to be drawn, given their methodological heterogeneity and the numerous confounding environmental factors.
To this date, only two studies have focused on the potential neurodevelopmental effects of general anesthesia during the prenatal period, even though general anesthesia for non-obstetric surgery during pregnancy affects up to 3% of pregnant women.
This observational ambidirectional study would be the first to investigate the potential neurodevelopmental effects of prenatal exposure to anesthesia, whether general or regional, for surgery during pregnancy. It would thus differentiate between the contribution of surgical stress and that of anesthetic agents in any observed modifications.
The aim of the study is:
Are there any subtle modifications of executive functions associated with prenatal exposure to anesthesia during non-obstetric surgery during pregnancy?
To investigate this, parents of the participating children will be asked to complete a standardized parental telephone questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF). This parental questionnaire allows for evaluating children's behaviors related to executive functions.
Researchers will compare the score derived from the "BRIEF" parental questionnaire (BRIEF score) between three groups of children aged from 5 to 12 years old, born between 2011 and 2018 at Caen University Hospital:
- The " General anesthesia " group: children whose mothers underwent general anesthesia for non-obstetric surgery during pregnancy (N: 62).
- The " Locoregional anesthesia " group: children whose mothers underwent regional anesthesia for non-obstetric surgery during pregnancy (N: 31).
- The " Control " group: children whose mothers did not undergo any surgical intervention during pregnancy (N: 62).
The first aim of our study is to investigate the presence of a significant difference in the BRIEF score between the three groups.
The seconds aims are to assess the cognitive functioning of patients in their daily lives (school, parental home, and extracurricular activities).
Detailed description
The study : "Association Between Prenatal Anesthesia Exposure and Neurodevelopmental Outcome : an Ambidirectional Cohort Study" is a single-center, ambidirectional, observational cohort study conducted at the University Hospital Center of Caen (CHU Caen).
Inclusion criteria :
The study groups "General Anesthesia" (GA group) and "Locoregional Anesthesia" (LRA group) are derived from a previous Caen University Hospital cohort, consisting of children whose mothers underwent general or regional anesthesia for non-obstetric surgery during pregnancy.
This previous cohort was established in 2021 for an unpublished research project consisting of 179 patients who underwent non-obstetric surgeries during pregnancy. These pregnant women who underwent surgery were identified through the Caen University hospital electronic database spanning from 2011 to 2020, as surgical procedures for pregnant women started to be documented since 2011 in the medical database of this hospital.
The "control group" will be formed by including children born at Caen University Hospital, the same day, right before and right after the children in the LRA group, but whose mothers did not undergo any surgical intervention during pregnancy.
The number of exposed patients (N=93) is comparable to prospective studies investigating the effect of postnatal general anesthesia on neurodevelopmental outcomes. It is also comparable to and higher than the two studies investigating the effect of prenatal general anesthesia on neurodevelopmental outcomes.
Matching :
The matching of the GA and LRA groups will be done based on the following three adjustment factors:
- Socio-economic level (parental monthly net income within a range of 500 euros)
- Age at the time of testing
- Gender of the child
Inclusion process:
After providing the information sheet and receiving the signed consent form from the legal guardian of the child, the elements of the parental telephone interview will be collected from the child's parents, prospectively, on a standardized data collection sheet during an estimated phone call duration of approximately forty minutes.
The phone call will consist of two parts :
- The standardized parental questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF).
- The parental hetero-questionnaire about their child's cognitive functioning in their daily life and medical history.
Both the parental standardized BRIEF questionnaire and our parental hetero-questionnaire will contribute to fulfilling the study objectives.
The parental hetero-questionnaire is the result of a discussion between clinicians specialized in pediatric and obstetric anesthesia and researchers specialized in the neurocognitive development of children.
Several anamnestic data from the medical records of the patients and their child such as progress of pregnancy, childbirth history, history of general anesthesia during childhood, hospitalization during childhood,, will also be collected retrospectively on a standardized data collection sheet.
Statistical Methodology:
The number of subjects included in the Caen University Hospital cohort comprises : 31 patients in the "locoregional anesthesia" (LRA) group with a 1:2 matching with the "general anesthesia" (GA) group, resulting in 62 patients.
The "control" group is also matched with a 1:2 ratio with the "LRA" group, resulting in 62 patients.
The significance level is set at 5%. Data will be collected using Excel 2022 software (Microsoft Corporation, Redmond, WA, USA). Discrete variables will be expressed as number of cases (%). Continuous variables will be presented as mean ± standard deviations for normally distributed data or as median (95% confidence interval) for non-normally distributed data.
The statistical software used will be Statistica 12, Statsoft®.
Data Management:
The data will be entered into a spreadsheet for statistical analysis of the collected values. These data will only be used for this study, and the sponsor undertakes not to disclose them to third parties. The data processing will comply with the General Data Protection Regulation (GDPR) guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | – | Other: Parental telephone interview with standardized parental questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF), Other: Parental questionnaire about their child's cognitive functioning in their daily life and medical history.Children whose mothers underwent general anesthesia for non-obstetric surgery during pregnancy. |
| Locoregional anesthesia | – | Other: Parental telephone interview with standardized parental questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF), Other: Parental questionnaire about their child's cognitive functioning in their daily life and medical history.Children whose mothers underwent regional anesthesia for non-obstetric surgery during pregnancy. |
| Control | – | Other: Parental telephone interview with standardized parental questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF), Other: Parental questionnaire about their child's cognitive functioning in their daily life and medical history.Children whose mothers did not undergo any surgical intervention during pregnancy. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children born between 2011 and 2018 at Caen University Hospital : * Whose mothers underwent general anesthesia for non-obstetric surgery during pregnancy (the "general anesthesia" group). * Whose mothers underwent locoregional anesthesia for non-obstetric surgery during pregnancy (the "locoregional anesthesia" group). * Whose mothers who did not undergo any surgical intervention during pregnancy (the "control" group).
Key inclusion criteria (2 listed)
- Children born between 2011 and 2018 at Caen University Hospital
- Children whose mothers underwent surgery for non-obstetrical reasons under general or locoregional anesthesia, or did not undergo any surgical intervention.
Key exclusion criteria (7 listed)
- Lost to follow-up
- Incomplete medical files
- Refusal of either parent or legal guardian
- Children with condition presenting independent risk factors for impaired neurocognitive development such as : neonatal hypoxia-ischemia, neurological disorder, neuromuscular disorder, complex cardiac or genetic disorders
- Children with a known or suspected genetic syndrome
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 |
|---|---|---|
| Parental telephone interview with standardized parental questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF)The "Behaviour Rating Inventory of Executive Function" (BRIEF) is a parental questionnaire that assesses the executive functions of children aged 5 to 18 years old. It consists of 86 questions grouped into 8 scales: inhibition, flexibility, emotional control, initiation, material organization, working memory, planning/organization, and monitoring. It provides information on a global scale (score) regarding subtle and subclinical changes in various executive functions. | Other | Control, General anesthesia, Locoregional anesthesia |
| Parental questionnaire about their child's cognitive functioning in their daily life and medical history.Standardized questionnaire includes : The child's medical history and cognitive functioning (at school, parental home, and during extracurricular activities), home environment, parent's child socioeconomic status and emotional climate. | Other | Control, General anesthesia, Locoregional anesthesia |
Primary outcome
The "Behavior Rating Inventory of Executive Function" composite score
Time frame: Through the fourty minute phone call to the child's legal guardian. All phone calls will be conducted during the course of the study, which lasts an average of 2 months."
The "Behaviour Rating Inventory of Executive Function" (BRIEF) is a parental questionnaire that assesses the executive functions of children aged 5 to 18 years old. It consists of 86 questions grouped into 8 scales: inhibition, flexibility, emotional control, initiation, material organization, working memory, planning/organization, and monitoring. It provides information on a global scale (score) regarding subtle and subclinical changes in various executive functions
1 secondary outcome
The child's cognitif functioning (at school, parental home, and during extracurricular activities), and medical history.
Time frame: Through the fourty minute phone call to the child's legal guardian. All phone calls will be conducted the course during of the study, which lasts an average of 2 months."
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 26 Mar 2025.
- Background: PubMed 36638508Salaun JP, Chagnot A, Cachia A, Poirel N, Datin-Dorriere V, Dujarrier C, Lemarchand E, Rolland M, Delalande L, Gressens P, Guillois B, Houde O, Levard D, Gakuba C, Moyon M, Naveau M, Orliac F, Orliaguet G, Hanouz JL, Agin V, Borst G, Vivien D. Consequences of General Anesthesia in Infancy on Behavior and Brain Structure. Anesth Analg. 2023 Feb 1;136(2):240-250. doi: 10.1213/ANE.0000000000006233. Epub 2022 Oct 27.
- Background: PubMed 36283123Bleeser T, Devroe S, Lucas N, Debels T, Van de Velde M, Lemiere J, Deprest J, Rex S. Neurodevelopmental outcomes after prenatal exposure to anaesthesia for maternal surgery: a propensity-score weighted bidirectional cohort study. Anaesthesia. 2023 Feb;78(2):159-169. doi: 10.1111/anae.15884. Epub 2022 Oct 25.
- Background: PubMed 29532559Shi Y, Hu D, Rodgers EL, Katusic SK, Gleich SJ, Hanson AC, Schroeder DR, Flick RP, Warner DO. Epidemiology of general anesthesia prior to age 3 in a population-based birth cohort. Paediatr Anaesth. 2018 Jun;28(6):513-519. doi: 10.1111/pan.13359. Epub 2018 Mar 13.
- Background: PubMed 30893117Marchesini V, Disma N. Anaesthetic neuroprotection in children: does it exist or is it all just bad? Curr Opin Anaesthesiol. 2019 Jun;32(3):363-369. doi: 10.1097/ACO.0000000000000723.
- Background: PubMed 21241795Paule MG, Li M, Allen RR, Liu F, Zou X, Hotchkiss C, Hanig JP, Patterson TA, Slikker W Jr, Wang C. Ketamine anesthesia during the first week of life can cause long-lasting cognitive deficits in rhesus monkeys. Neurotoxicol Teratol. 2011 Mar-Apr;33(2):220-30. doi: 10.1016/j.ntt.2011.01.001. Epub 2011 Jan 15.
- Background: PubMed 28177852Andropoulos DB, Greene MF. Anesthesia and Developing Brains - Implications of the FDA Warning. N Engl J Med. 2017 Mar 9;376(10):905-907. doi: 10.1056/NEJMp1700196. Epub 2017 Feb 8. No abstract available.
- Background: PubMed 32898216Walkden GJ, Gill H, Davies NM, Peters AE, Wright I, Pickering AE. Early Childhood General Anesthesia and Neurodevelopmental Outcomes in the Avon Longitudinal Study of Parents and Children Birth Cohort. Anesthesiology. 2020 Nov 1;133(5):1007-1020. doi: 10.1097/ALN.0000000000003522.
- Background: PubMed 27272582Sun LS, Li G, Miller TL, Salorio C, Byrne MW, Bellinger DC, Ing C, Park R, Radcliffe J, Hays SR, DiMaggio CJ, Cooper TJ, Rauh V, Maxwell LG, Youn A, McGowan FX. Association Between a Single General Anesthesia Exposure Before Age 36 Months and Neurocognitive Outcomes in Later Childhood. JAMA. 2016 Jun 7;315(21):2312-20. doi: 10.1001/jama.2016.6967.
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- Background: PubMed 26507180Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, Stargatt R, Bellinger DC, Schuster T, Arnup SJ, Hardy P, Hunt RW, Takagi MJ, Giribaldi G, Hartmann PL, Salvo I, Morton NS, von Ungern Sternberg BS, Locatelli BG, Wilton N, Lynn A, Thomas JJ, Polaner D, Bagshaw O, Szmuk P, Absalom AR, Frawley G, Berde C, Ormond GD, Marmor J, McCann ME; GAS consortium. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. Lancet. 2016 Jan 16;387(10015):239-50. doi: 10.1016/S0140-6736(15)00608-X. Epub 2015 Nov 4.
- Background: PubMed 30782342McCann ME, de Graaff JC, Dorris L, Disma N, Withington D, Bell G, Grobler A, Stargatt R, Hunt RW, Sheppard SJ, Marmor J, Giribaldi G, Bellinger DC, Hartmann PL, Hardy P, Frawley G, Izzo F, von Ungern Sternberg BS, Lynn A, Wilton N, Mueller M, Polaner DM, Absalom AR, Szmuk P, Morton N, Berde C, Soriano S, Davidson AJ; GAS Consortium. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial. Lancet. 2019 Feb 16;393(10172):664-677. doi: 10.1016/S0140-6736(18)32485-1. Epub 2019 Feb 14.
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- 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.
Jean-Philippe Salaün, MD PhD principal investigator
University Hospital, Caen
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, 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 2 inclusion and 7 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 26 Mar 2025. 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?
The "Behavior Rating Inventory of Executive Function" composite score (time frame: Through the fourty minute phone call to the child's legal guardian. All phone calls will be conducted during the course of the study, which lasts an average of 2 months."). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06052878, which also lists 30 linked publications.
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 26 Mar 2025.