Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-01 @ 1:08 AM
Study NCT ID:
NCT06633406
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-11-12
First Post:
2024-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-08', 'studyFirstSubmitDate': '2024-09-20', 'studyFirstSubmitQcDate': '2024-10-07', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wechsler full-scale intelligence quotient', 'timeFrame': '1,5 hours (duration of intelligence testing and completion of questionnaires)', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anaesthesia', 'anaesthesia-induced neurotoxicity', 'pregnancy'], 'conditions': ['General Anaesthesia During Pregnancy']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '27 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children from women who delivered in one of the participating hospitals', 'healthyVolunteers': True, 'eligibilityCriteria': 'Prenatal anaesthesia exposure:\n\nInclusion Criteria:\n\n* 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\n* No prenatal anaesthesia exposure: Children not exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero\n* Children born in 2000-2023\n* (Parental) informed consent\n\nExclusion Criteria:\n\n* Children whose mothers underwent obstetric surgery or foetal surgery/interventions during the same pregnancy.\n* No Dutch-speaking children\n* Diagnosis of severe disability of genetic origin (e.g., Fragil X, Down syndrome,…), history of head trauma, major congenital birth defects'}, 'identificationModule': {'nctId': 'NCT06633406', 'acronym': 'PAE-IQ', 'briefTitle': 'Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia for Maternal Abdominal Surgery: a Propensity Score Weighted Multicentre Clinical Bidirectional Cohort Study.', 'orgStudyIdInfo': {'id': 'S68647'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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', 'interventionNames': ['Other: Age-appropriate Wechsler Intelligence Test', 'Other: Disruptive Behavior Disorders Rating Scale', 'Other: Social Responsiveness Scale']}, {'label': 'No Prenatal Anaesthesia Exposure', 'description': 'Children not exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero', 'interventionNames': ['Other: Age-appropriate Wechsler Intelligence Test', 'Other: Disruptive Behavior Disorders Rating Scale', 'Other: Social Responsiveness Scale']}], 'interventions': [{'name': 'Age-appropriate Wechsler Intelligence Test', 'type': 'OTHER', 'description': '2.5-6 years: Wechsler Preschool and Primary Scale of Intelligence for children (WPPSI IV)\n\n7-16 years: Wechsler Intelligence Scale for Children (WISC V)\n\n\\>17 years: Wechsler Adult Intelligence Scale (WAIS IV)', 'armGroupLabels': ['No Prenatal Anaesthesia Exposure', 'Prenatal Anaesthesia Exposure']}, {'name': 'Disruptive Behavior Disorders Rating Scale', 'type': 'OTHER', 'description': 'Dutch version of the Disruptive Behavior Disorders Rating Scale', 'armGroupLabels': ['No Prenatal Anaesthesia Exposure', 'Prenatal Anaesthesia Exposure']}, {'name': 'Social Responsiveness Scale', 'type': 'OTHER', 'description': '3-18 years: social responsiveness scale 2 (SRS-2)\n\n\\>19 years: Social Responsiveness Scale - Adult version (SRS-A)', 'armGroupLabels': ['No Prenatal Anaesthesia Exposure', 'Prenatal Anaesthesia Exposure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Bonheiden', 'state': 'Antwerpen', 'country': 'Belgium', 'facility': 'Imeldaziekenhuis', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '8800', 'city': 'Roeselare', 'state': 'West-Flanders', 'country': 'Belgium', 'facility': 'AZ Delta', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}], 'overallOfficials': [{'name': 'Sarah Devroe, MD, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}