Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia (PAE-IQ)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: General Anaesthesia During Pregnancy
• Intervention / Treatment: Other: Age-appropriate Wechsler Intelligence Test; Other: Disruptive Behavior Disorders Rating Scale; Other: Social Responsiveness Scale

• Study Type: Observational
• Enrollment (Estimated): 192

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen
    • Bonheiden, Antwerpen, Belgium, 2820
      • Imeldaziekenhuis
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven
  • West-Flanders
    • Roeselare, West-Flanders, Belgium, 8800
      • AZ Delta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

children from women who delivered in one of the participating hospitals

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Age-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); Other: Disruptive Behavior Disorders Rating Scale; Dutch version of the Disruptive Behavior Disorders Rating Scale; Other: Social Responsiveness Scale; 3-18 years: social responsiveness scale 2 (SRS-2) >19 years: Social Responsiveness Scale - Adult version (SRS-A)
No Prenatal Anaesthesia Exposure; Children not exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero	Other: Age-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); Other: Disruptive Behavior Disorders Rating Scale; Dutch version of the Disruptive Behavior Disorders Rating Scale; Other: Social Responsiveness Scale; 3-18 years: social responsiveness scale 2 (SRS-2) >19 years: Social Responsiveness Scale - Adult version (SRS-A)
Prenatal exposure to maternal inflammation; Children prenatally exposed to maternal inflammation, specifically those born to mothers with inflammatory bowel disease (IBD)	Other: Age-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); Other: Disruptive Behavior Disorders Rating Scale; Dutch version of the Disruptive Behavior Disorders Rating Scale; Other: Social Responsiveness Scale; 3-18 years: social responsiveness scale 2 (SRS-2) >19 years: Social Responsiveness Scale - Adult version (SRS-A)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wechsler full-scale intelligence quotient	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.	1,5 hours (duration of intelligence testing and completion of questionnaires)

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Sarah Devroe, MD, Phd, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: pregnancy; anaesthesia; anaesthesia-induced neurotoxicity
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders
• Other Study ID Numbers: S68647

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No