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Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia

Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia for Maternal Abdominal Surgery: A Propensity Score Weighted Multicentre Clinical Bidirectional Cohort Study.

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06633406
Acronym
PAE-IQ
Enrollment
192
Registered
2024-10-09
Start date
2024-10-14
Completion date
2027-12-31
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anaesthesia During Pregnancy

Keywords

anaesthesia, anaesthesia-induced neurotoxicity, pregnancy

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 and with those of children prenatally exposed to maternal inflammation.

Interventions

OTHERAge-appropriate Wechsler Intelligence Test

2.5-6 years: Wechsler Preschool and Primary Scale of Intelligence for children (WPPSI IV) 7-16 years: Wechsler Intelligence Scale for Children (WISC V) \>17 years: Wechsler Adult Intelligence Scale (WAIS IV)

OTHERDisruptive Behavior Disorders Rating Scale

Dutch version of the Disruptive Behavior Disorders Rating Scale

OTHERSocial Responsiveness Scale

3-18 years: social responsiveness scale 2 (SRS-2) \>19 years: Social Responsiveness Scale - Adult version (SRS-A)

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
2 Years to 27 Years
Healthy volunteers
Yes

Inclusion 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 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

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

Design outcomes

Primary

MeasureTime frameDescription
Wechsler full-scale intelligence quotient1,5 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026