Защита недоношенных детей от инфекций дыхательных путей и хрипов с помощью бактериальных лизатов. (PROTEA)
Защита недоношенных детей поздней и умеренной степени тяжести от инфекций дыхательных путей и хрипов на первом году жизни с помощью бактериальных лизатов.
The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
This is a randomised placebo-controlled trial including 500 otherwise healthy moderate-late preterm infants. Participants will receive bacterial lysate (OM-85/Broncho-Vaxom, 3,5mg) or placebo powder for ten days each month, from 6-10 weeks after birth until 12 months after birth. At 12 months, parents of participants are asked to join in Protea-2. If they do, participants in the treatment arm of year 1 are randomised again over placebo and OM-85 and treated until the age of 24 months. Clinical data will be continuously collected by e-Health and 3 (possibly digital) study visits; with optional biological sampling and lung function at baseline, 6 and 12 months.
Main study parameters are doctor diagnosed lower RTI and wheezing episodes in the first year of life. Biological sampling will allow investigation of immune maturation, as well as microbiome development in the respiratory tract and gut. Also, biomarkers for risk-group selection and/or treatment success will be examined.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 3
Контакты и местонахождение
Контакты исследования
- Имя: Gerdien Tramper, MD PhD
- Номер телефона: 0031 10 4617126
- Электронная почта: proteastudie@franciscus.nl
Места учебы
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South Holland
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Rotterdam, South Holland, Нидерланды, 3045PM
- Рекрутинг
- Franciscus Gasthuis & Vlietland
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Контакт:
- Gerdien Tramper, MD PhD
- Номер телефона: +311046117126
- Электронная почта: proteastudie@franciscus.nl
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Контакт:
- Электронная почта: wetenschapsbureau@franciscus.nl
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Gestational age at delivery between 30+0 and 35+6 weeks
- Postnatal age at least 6 weeks at randomization & postmenstrual age at least 37 weeks
- Written informed consent by both parents or formal caregivers
Exclusion Criteria:
- Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group); hemodynamic significant cardiac disease; immunodefi-ciency; severe failure to thrive; birth asphyxia with predicted poor neurological out-come; syndrome or serious congenital disorder.
- Maternal TNF-alpha inhibitors or other immunosuppression during pregnancy and/or breastfeeding
- Parents unable to speak and read Dutch/English language
- Known allergic hypersensitivity to the active ingredients/substance or to any of the excipients.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: Broncho-Vaxom treatment
Infants in this arm will be given 3,5mg bacterial lysate (OM-85) 10 days per month from 6 weeks after birth until 12 months of age. At age 12 months they will be (if informed consent for Protea-2 is provided) randomised over Broncho-Vaxom treatment and placebo again. |
Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.
Другие имена:
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Плацебо Компаратор: Placebo
Infants in this arm will be given a placebo powder from a capsule that will be indistinguishable from the active study drug. |
Placebo powder from a capsule will be given, which will be indistinguishable from the active study drug. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life
Временное ограничение: In the first year of life.
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Recorded by frequent questionnaires |
In the first year of life.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Time to first lower RTI or wheezing episode
Временное ограничение: In the first and second year of life.
|
Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life. |
In the first and second year of life.
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Total number of RTI
Временное ограничение: In the first and second year of life.
|
Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life. |
In the first and second year of life.
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Total number of wheezing episodes
Временное ограничение: In the first and second year of life.
|
Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life. |
In the first and second year of life.
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Distribution of viruses
Временное ограничение: In the first year of life.
|
Viruses present in the nasofarynx during complaints of lower respiratory tract infection or wheezing. Nasofaryngeal swabs will be taken in case of complaints during the first year of life. In the second year of life this will not be done. |
In the first year of life.
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Medication use (bronchodilators, corticosteroids, antibiotics)
Временное ограничение: In the first and second year of life.
|
Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life. |
In the first and second year of life.
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Lung function as measured by expiratory variability index (Ventica)
Временное ограничение: In the first year of life.
|
Measured at age 6-10 weeks (baseline), 6 months and 12 months in a subset of participants. |
In the first year of life.
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Quality of life questionnaires
Временное ограничение: In the first and second year of life.
|
Recorded by extensive questionnaires every six months in the first and second year of life. |
In the first and second year of life.
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(serious) adverse events
Временное ограничение: In the first year of life.
|
Will be reported by parents immediately. Respiratory episodes are not regarded as an (S)AE since these episodes comprise primary and secondary outcomes. (S)AE's are only expected in the first year of life because the treatment stops at the age of 12 months. |
In the first year of life.
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Serum specific IgE (allergen sensitization) at 12 months
Временное ограничение: At age 12 months
|
Total IgE and house dust mite specific IgE |
At age 12 months
|
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Infant vaccination titers at 12 months
Временное ограничение: At age 12 months
|
Vaccination titers of haemohilus influenza type B, pneumococci, tetanus |
At age 12 months
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Costs- and cost-effectiveness
Временное ограничение: In the first and second year of life.
|
Estimated from information from standardized questionnaires |
In the first and second year of life.
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Gut and respiratory microbiome composition
Временное ограничение: In the first year of life.
|
Measured from faeces and nasofaryngeal swabs taken at age 6-10 weeks, 6 months and 12 months. |
In the first year of life.
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Secretory IgA in saliva or nasal lining fluid
Временное ограничение: In the first year of life
|
Saliva will be collected at age 6-10 weeks, 6 months and 12 months. |
In the first year of life
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Immune maturation: immune cells in nasal epithelium
Временное ограничение: In the first year of life
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Collected by nasal scraping at age 6-10 weeks, 6 months and 12 months. Analysed using masscytometry. |
In the first year of life
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Immune maturation: chemokines and cytokines in nasal lining fluid
Временное ограничение: In the first year of life
|
Collected by nasosorption at age 6-10 weeks, 6 months and 12 months. Analysed using Luminex cyto/chemokine assay. |
In the first year of life
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Immune maturation: immune cells in bloodsamples
Временное ограничение: In the first year of life
|
Collected by blooddraws at age 6-10 weeks, 6 months and 12 months. Analysed using masscytometry. |
In the first year of life
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Serum IgE (total and specific to house dust mite)
Временное ограничение: At age 12 months
|
Measured in blood samples which will be drawn at age 12 months |
At age 12 months
|
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Immune maturation: Single cell transcriptomics
Временное ограничение: At age 12 months
|
Performed on blood drawn at age 12 months |
At age 12 months
|
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Whole blood stimulation essays
Временное ограничение: At age 12 months
|
Performed on blood drawn at age 12 months |
At age 12 months
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Biomarkers predictive of high morbidity and/or treatment success
Временное ограничение: In the first year of life.
|
From combined microbial and immunological data |
In the first year of life.
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Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
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Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Акушерские роды, преждевременные роды
- Осложнения акушерских родов
- Осложнения беременности
- Инфекции
- Заболевания дыхательных путей
- Признаки и симптомы, Респираторные
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Преждевременные роды
- Инфекции дыхательных путей
- Дыхательные звуки
- Бронхо-Ваксом
Другие идентификационные номера исследования
- NL76165.100.20
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Researchdata will be shared in data repositories according to the FAIR principle. Clinical data about respiratory health will be shared in the DANS repository. Inlcuding metadata which will ensure reusability. Sequencing data will be shared online in the ENA repository which will provide an unique global identifier. All used bioinformatics pipelines for data analysis will be made accessible on a GitHub account. Immunological data will be shared in NCBI Gene Expression omnibus and ImmPort. Used analysis pipelines for the transcriptomics data will also be tracked and can be shared using a Github account.
All data shared will be pneudonymized.
Сроки обмена IPD
Data will come available after publication of the data in articles by initating researchers.
Критерии совместного доступа к IPD
Data will be available under restricted access. A request for data sharing will include at least the reason for request (for what will the receiver use the data?) and agreements about authorship.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .