Neurodevelopmental Outcome After Prenatal Anesthesia

NCT06052878 | Completed DMC

• 1 other identifier: CHUCaen
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Neurodevelopmental Disorders; Child Behavior

Keywords

general anesthesia; regional anesthesia; pregnancy; executive functions; developing brain; neurodevelopment; surgery

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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."

Study Arms (3)

General anesthesia

Children whose mothers underwent general anesthesia for non-obstetric surgery during pregnancy.

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.

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.

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.

Interventions

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.

Control; General anesthesia; Locoregional anesthesia

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.

Control; General anesthesia; Locoregional anesthesia

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

University Hospital Caen Normandie

Caen, Normandy, 14000, France

Location

Related Publications (30)

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MeSH Terms

Conditions

Neurodevelopmental Disorders; Child Behavior

Interventions

Health Records, Personal

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques

Study Officials

• Jean-Philippe Salaün, MD PhD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: September 25, 2023
• Study Start: October 9, 2023
• Primary Completion: February 23, 2024
• Study Completion: February 26, 2024
• Last Updated: March 26, 2025

Record last verified: 2024-03

Locations

FR (1)