Association Between Prenatal Anesthesia Exposure and Neurodevelopmental Outcome : an Ambi-directional Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- The "Behavior Rating Inventory of Executive Function" composite score
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
The "Behavior Rating Inventory of Executive Function" composite score
时间窗: 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
次要结局
- 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.")