Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-14

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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Conditions

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General Anaesthesia During Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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

Age-appropriate Wechsler Intelligence Test

Intervention Type 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

Intervention Type OTHER

Dutch version of the Disruptive Behavior Disorders Rating Scale

Social Responsiveness Scale

Intervention Type OTHER

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

Age-appropriate Wechsler Intelligence Test

Intervention Type 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

Intervention Type OTHER

Dutch version of the Disruptive Behavior Disorders Rating Scale

Social Responsiveness Scale

Intervention Type OTHER

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)

Age-appropriate Wechsler Intelligence Test

Intervention Type 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

Intervention Type OTHER

Dutch version of the Disruptive Behavior Disorders Rating Scale

Social Responsiveness Scale

Intervention Type OTHER

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

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

Interventions

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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)

Intervention Type OTHER

Disruptive Behavior Disorders Rating Scale

Dutch version of the Disruptive Behavior Disorders Rating Scale

Intervention Type OTHER

Social Responsiveness Scale

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

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

27 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes