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Search / Trial NCT06633406

Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Oct 7, 2024

Trial Information

Current as of October 19, 2025

Enrolling by invitation

Keywords

Anaesthesia Anaesthesia Induced Neurotoxicity Pregnancy

ClinConnect Summary

This is a observational, multicenter study in Belgium that asks whether being exposed to general anesthesia before birth (because the mother needed abdominal surgery during pregnancy) affects a child’s intelligence and overall neurodevelopment later on. The researchers will compare children who were exposed in utero to those who were not, using standard IQ tests that fit each child’s age (Wechsler scales). They will also look at behavior and social skills through questionnaires.

Who can be included? About 128 children aged 2 to 27 years, born between 2000 and 2023, from three Belgian hospitals (Imelda Hospital in Bonheiden, UZ Leuven, and AZ Delta in Roeselare). Parents must give consent, and the child should be Dutch-speaking. The study includes two groups: children whose mothers had prenatal general anesthesia for abdominal surgery (e.g., to treat appendix issues, ovarian problems, gallbladder issues, or similar diagnostic procedures) and children whose mothers did not have anesthesia exposure during pregnancy. Exclusions include pregnancies with obstetric/fetal surgery, severe genetic disabilities, or major birth defects. The study is currently enrolling by invitation, with results expected around 2027. Data are not shared publicly, and the project is led by KU Leuven with appropriate oversight.

Gender

ALL

Eligibility criteria

  • 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 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

About Universitaire Ziekenhuizen Ku Leuven

Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.

Locations

Leuven, Vlaams Brabant, Belgium

Bonheiden, Antwerpen, Belgium

Roeselare, West Flanders, Belgium

Patients applied

0 patients applied

Trial Officials

Sarah Devroe, MD, Phd

Principal Investigator

UZ Leuven

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported