Observational Study of the Management of Infants With Congenital CMV
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Congenital Cmv. Базовые параметры: до 10 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
- Великобритания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This is an observational, prospective/retrospective multicentre, cohort study of children diagnosed with cCMV. This study will contribute to a wider study also recruiting participants in Europe and other countries worldwide. No investigations or treatment will be carried out that are not part of routine clinical practice. Infants with cCMV are routinely followed up from an infectious diseases, audiology, ophthalmology and neurodevelopmental perspective until approximately 6 years of age, or longer if there are ongoing issues. Some children will be retrospectively diagnosed with cCMV in later childhood. Recruitment can be from any centre that manages these patients and has agreed to participate in the study.
Подробное описание
Cytomegalovirus (CMV) is the most frequent cause of congenital infection worldwide, occurring in 0.2-2% of live births. It is also the most frequent cause of non-genetic hearing loss, and an important cause of neurodevelopmental delay. Clinical diagnosis of maternal infection during pregnancy is unreliable in most patients and laboratory diagnosis can be challenging, especially in non-primary infections. Screening of congenital CMV infection (cCMV) in newborns is not recommended in most countries and only targeted screening is performed in some cases (children who fail hearing screening or with abnormalities compatible with cCMV in physical exams).
The main focus of the study is to identify patient and treatment characteristics that are associated with outcome. This will allow improved patient care in the future.
Первичные конечные точки
- Measuring cases of cCMV in the UK [Срок оценки: 15 years]
- Clinical characteristics [Срок оценки: 15 years]
- To evaluate risk factors in children with cCMV for long term sequelae [Срок оценки: 15 years]
- Adverse events [Срок оценки: 15 years]
- To evaluate the prognostic value of microbiological variables [Срок оценки: 15 years]
- To evaluate the prognostic value of image findings [Срок оценки: 15 years]
- To evaluate associated outcomes with different treatment strategies [Срок оценки: 15 years]
Критерии участия
Inclusion Criteria: Patients of either sex that have been diagnosed with cCMV infection:
- Through confirmed detection of CMV in urine or saliva, by CMV-DNA PCR (or viral culture / Shell-vial) and/or CMV detection in blood or CSF by PCR within the first 21 days of life.
- Children with cCMV retrospectively diagnosis by positive CMV-DNA PCR in dried blood spots (DBS), collected within 21 days of life.
- Diagnosed by positive CMV-DNA PCR in dried umbilical cord blood or donated/stored umbilical cord blood sample
- Children whose parents give their informed consent to participate in the study
- Age less than 11 years old
Критерии исключения
- Refusal to sign written informed consent of parents/ legal guardian.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Великобритания · 1 центр
- St George's University of London — London
Идентификаторы
NCT: NCT05855889 · 2021.0118