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Enrolling by invitation NCT06633406

Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia

Observational General Anaesthesia During Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Age-appropriate Wechsler Intelligence Test, Disruptive Behavior Disorders Rating Scale, Social Responsiveness Scale.
Who it may be relevant to
Registry conditions: General Anaesthesia During Pregnancy. Basic parameters: 2 years — 27 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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)

Primary outcome measures

  • Wechsler full-scale intelligence quotient [Time frame: 1,5 hours (duration of intelligence testing and completion of questionnaires)]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Belgium · 3 centers
  • Imeldaziekenhuis — Bonheiden
  • UZ Leuven — Leuven
  • AZ Delta — Roeselare

Identifiers

NCT: NCT06633406 · S68647

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗