Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia

• Conditions: General Anaesthesia During Pregnancy
• Interventions: Other: Age-appropriate Wechsler Intelligence Test; Other: Disruptive Behavior Disorders Rating Scale; Other: Social Responsiveness Scale

• Registration Number: NCT06633406
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-10-07
• Study First Posted: 2024-10-09
• Study Start: 2024-10-14
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-12
• Primary Completion: 2027-10
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 128

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 born in 2000-2023
• (Parental) informed consent

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prenatal Anaesthesia Exposure	Social Responsiveness Scale	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	Age-appropriate Wechsler Intelligence Test	Children not exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero
No Prenatal Anaesthesia Exposure	Disruptive Behavior Disorders Rating Scale	Children not exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero
No Prenatal Anaesthesia Exposure	Social Responsiveness Scale	Children not exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero
Prenatal Anaesthesia Exposure	Disruptive Behavior Disorders Rating Scale	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
Prenatal Anaesthesia Exposure	Age-appropriate Wechsler Intelligence Test	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

Primary Outcome Measures

Name	Time	Method
Wechsler full-scale intelligence quotient	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.

Trial Locations

Locations (3)

Imeldaziekenhuis; 🇧🇪 Bonheiden, Antwerpen, Belgium

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium

AZ Delta; 🇧🇪 Roeselare, West-Flanders, Belgium