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

U

Universitaire Ziekenhuizen KU Leuven

Status

Invitation-only

Conditions

General Anaesthesia During Pregnancy

Treatments

Other: Social Responsiveness Scale
Other: Disruptive Behavior Disorders Rating Scale
Other: Age-appropriate Wechsler Intelligence Test

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

192 estimated patients

Sex

All

Ages

2 to 27 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

192 participants in 3 patient groups

Prenatal Anaesthesia Exposure
Description:
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
Treatment:
Other: Age-appropriate Wechsler Intelligence Test
Other: Disruptive Behavior Disorders Rating Scale
Other: Social Responsiveness Scale
No Prenatal Anaesthesia Exposure
Description:
Children not exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero
Treatment:
Other: Age-appropriate Wechsler Intelligence Test
Other: Disruptive Behavior Disorders Rating Scale
Other: Social Responsiveness Scale
Prenatal exposure to maternal inflammation
Description:
Children prenatally exposed to maternal inflammation, specifically those born to mothers with inflammatory bowel disease (IBD)
Treatment:
Other: Age-appropriate Wechsler Intelligence Test
Other: Disruptive Behavior Disorders Rating Scale
Other: Social Responsiveness Scale

Trial contacts and locations

3

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Central trial contact

Arjen Brenders, MD

Data sourced from clinicaltrials.gov

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