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Enrolling by Invitation

NCT Number: NCT06633406

Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia

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.

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Key information

Conditions

General Anaesthesia During Pregnancy

Age range

2 year–27 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Imeldaziekenhuis, Bonheiden, Antwerpen, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Disruptive Behavior Disorders Rating Scale

Other

Dutch version of the Disruptive Behavior Disorders Rating Scale

Social Responsiveness Scale

Other

3-18 years: social responsiveness scale 2 (SRS-2)

>19 years: Social Responsiveness Scale - Adult version (SRS-A)

Primary outcomes

  1. Wechsler full-scale intelligence quotient

    Time frame: 1,5 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: PAE-IQ

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 9, 2024
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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