Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia for Maternal Abdominal Surgery: A Propensity Score Weighted Multicentre Clinical Bidirectional Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 192
- 试验地点
- 3
- 主要终点
- Wechsler full-scale intelligence quotient
研究概览
简要总结
Every year in the European Union, thousands of babies are exposed to anaesthesia before they are born because their mothers need surgery during pregnancy. While these surgeries are necessary, there is a concern that the anaesthesia might affect the baby's brain development. However, there isn't enough research to know for sure how this exposure might impact the child's intelligence or behavior later in life.
The goal of this cohort study is to compare the intelligence and neurodevelopmental outcome of children prenatally exposed to general anaesthesia for maternal abdominal surgery with those of unexposed children and with those of children prenatally exposed to maternal inflammation.
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
- 2 Years 至 27 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Prenatal anaesthesia exposure:
- •Inclusion Criteria:
- •Prenatal anaesthesia exposure: Children exposed in utero to maternal general anaesthesia to allow laparoscopy or laparotomy for appendicectomy, adnexal pathology, cholecystectomy or for diagnostic procedures to rule out intra-abdominal pathology
- •No prenatal anaesthesia exposure: Children not exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero
- •Children exposed to inflammation: Children born to mothers diagnosed with inflammatory bowel disease (IBD) who had a flare-up during pregnancy without being exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero.
- •Children born in 2000-2023
- •(Parental) informed consent
排除标准
- •Children whose mothers underwent obstetric surgery or foetal surgery/interventions during the same pregnancy.
- •No Dutch-speaking children
- •Diagnosis of severe disability of genetic origin (e.g., Fragil X, Down syndrome,…), history of head trauma, major congenital birth defects
研究组 & 干预措施
Prenatal Anaesthesia Exposure
Children exposed in utero to maternal general anaesthesia to allow laparoscopy or laparotomy for appendicectomy, adnexal pathology, cholecystectomy or for diagnostic procedures to rule out intra-abdominal pathology
干预措施: Age-appropriate Wechsler Intelligence Test (Other)
Prenatal Anaesthesia Exposure
Children exposed in utero to maternal general anaesthesia to allow laparoscopy or laparotomy for appendicectomy, adnexal pathology, cholecystectomy or for diagnostic procedures to rule out intra-abdominal pathology
干预措施: Disruptive Behavior Disorders Rating Scale (Other)
Prenatal Anaesthesia Exposure
Children exposed in utero to maternal general anaesthesia to allow laparoscopy or laparotomy for appendicectomy, adnexal pathology, cholecystectomy or for diagnostic procedures to rule out intra-abdominal pathology
干预措施: Social Responsiveness Scale (Other)
No Prenatal Anaesthesia Exposure
Children not exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero
干预措施: Age-appropriate Wechsler Intelligence Test (Other)
No Prenatal Anaesthesia Exposure
Children not exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero
干预措施: Disruptive Behavior Disorders Rating Scale (Other)
No Prenatal Anaesthesia Exposure
Children not exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero
干预措施: Social Responsiveness Scale (Other)
Prenatal exposure to maternal inflammation
Children prenatally exposed to maternal inflammation, specifically those born to mothers with inflammatory bowel disease (IBD)
干预措施: Age-appropriate Wechsler Intelligence Test (Other)
Prenatal exposure to maternal inflammation
Children prenatally exposed to maternal inflammation, specifically those born to mothers with inflammatory bowel disease (IBD)
干预措施: Disruptive Behavior Disorders Rating Scale (Other)
Prenatal exposure to maternal inflammation
Children prenatally exposed to maternal inflammation, specifically those born to mothers with inflammatory bowel disease (IBD)
干预措施: Social Responsiveness Scale (Other)
结局指标
主要结局
Wechsler full-scale intelligence quotient
时间窗: 1,5 hours (duration of intelligence testing and completion of questionnaires)
Primary outcome will be the Wechsler full-scale intelligence quotient which will be assessed using the Wechsler Preschool and Primary Scale of Intelligence for children with an age of 2.5-6 years, the Wechsler Intelligence Scale for Children for children with an age of 7-16 years and the Wechsler Adult Intelligence Scale for children with an age of ≥ 17 years.
次要结局
未报告次要终点