Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia

NCT06633406 | Enrolling By Invitation DMC

• 1 other identifier: S68647
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 3

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.

Conditions

General Anaesthesia During Pregnancy

Keywords

anaesthesia; anaesthesia-induced neurotoxicity; pregnancy

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

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; Other: Disruptive Behavior Disorders Rating Scale; Other: Social Responsiveness Scale

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; Other: Disruptive Behavior Disorders Rating Scale; Other: Social Responsiveness Scale

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; Other: Disruptive Behavior Disorders Rating Scale; Other: Social Responsiveness Scale

Interventions

Age-appropriate Wechsler Intelligence Test OTHER

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)

No Prenatal Anaesthesia Exposure; Prenatal Anaesthesia Exposure; Prenatal exposure to maternal inflammation

Disruptive Behavior Disorders Rating Scale OTHER

Dutch version of the Disruptive Behavior Disorders Rating Scale

No Prenatal Anaesthesia Exposure; Prenatal Anaesthesia Exposure; Prenatal exposure to maternal inflammation

Social Responsiveness Scale OTHER

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

No Prenatal Anaesthesia Exposure; Prenatal Anaesthesia Exposure; Prenatal exposure to maternal inflammation

Eligibility Criteria

• Age: 2 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

children from women who delivered in one of the participating hospitals

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (3)

Imeldaziekenhuis

Bonheiden, Antwerpen, 2820, Belgium

Location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ Delta

Roeselare, West-Flanders, 8800, Belgium

Location

Study Officials

• Sarah Devroe, MD, Phd

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 9, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)