Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Age-appropriate Wechsler Intelligence Test, Disruptive Behavior Disorders Rating Scale, Social Responsiveness Scale.
- Кому может быть актуально
- Состояния в реестре: General Anaesthesia During Pregnancy. Базовые параметры: 2 лет — 27 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Бельгия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia for Maternal Abdominal Surgery: A Propensity Score Weighted Multicentre Clinical Bidirectional Cohort Study.
Обзор
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.
Вмешательства
- Другое 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) - Другое Disruptive Behavior Disorders Rating Scale
Dutch version of the Disruptive Behavior Disorders Rating Scale - Другое Social Responsiveness Scale
3-18 years: social responsiveness scale 2 (SRS-2) \>19 years: Social Responsiveness Scale - Adult version (SRS-A)
Первичные конечные точки
- Wechsler full-scale intelligence quotient [Срок оценки: 1,5 hours (duration of intelligence testing and completion of questionnaires)]
Критерии участия
Prenatal anaesthesia exposure:
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Бельгия · 3 центра
- Imeldaziekenhuis — Bonheiden
- UZ Leuven — Leuven
- AZ Delta — Roeselare
Идентификаторы
NCT: NCT06633406 · S68647