Neurodevelopmental Outcome After Prenatal Anesthesia

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

Interventions

OTHER

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

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.

Sponsors & Collaborators

• University Hospital, Caen

  lead OTHER

Principal Investigators

• Jean-Philippe Salaün, MD PhD · University Hospital, Caen

Eligibility

Min Age

5 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-10-09

Primary Completion

2024-02-23

Completion

2024-02-26

Countries

• France

Study Locations