In-Vivo Evaluation of Nebulized Aerosols Delivered Via Nasal Route
We hypothesize that infant and children will show different levels of acceptance of different interfaces while they receive inhaled therapy.
We also hypothesize that children will exhibit different amounts of time with the aerosol well aligned with the nostrils during transnasal aerosol delivery.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Aerosol medicine is widely used in treating pulmonary diseases in children. Delivering drugs via aerosol faces several challenges; some are related to the drug and the delivery methods and others to the patient behavior. The latter are crucial and can significantly affect the lung deposition of the drug. Infants are known to be obligate nose breathers making the transnasal route the natural approach for drug delivery in this age group. Different interfaces are already available in the market and are specifically designed to be used in children to improve the child acceptability of the interface and by the result to improve drug deposition. Due to limitations in the use of radiolabeled aerosols and pharmacokinetics/pharmacodynamics studies in infants and children, in-vitro models were developed. These models still lack biological variability which leads to overestimating lung deposition. So, real life correction factors are needed to improve current in-vitro modeling. Previous unpublished data from our laboratory showed that alignment of the aerosol stream with the nostrils is very important for pulmonary deposition.
Our objectives are to provide real life data of acceptance of different interfaces by infants and children and to provide a real life correction factor to improve current in-vitro modeling.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
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Arkansas
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Little Rock, Arkansas, Соединенные Штаты, 72202
- Arkansas Children's Hospital
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Born at term
- Healthy
- Pacifier user
- Newborn 1-6 week old
- Infants 6-8 month old
Exclusion Criteria:
- Chronic respiratory disease
- Cardiac disease
- Prematurity
- Neurological disease
- Allergy to Normal Saline
- Allergy to any components of the interfaces
Учебный план
Как устроено исследование?
Детали дизайна
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Term newborns 1-6 week old
A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces.
The interfaces that will be used are: tight mask, the angled PediNeb, the B&B adapter, mask placed at 2 cm from the face, the PediNeb T-piece, and a capped corrugated tubing placed 2 cm away from the face.
|
A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces.
The infants will be videotape while they receive inhaled aerosol, and sound will be captured.
The camera will be positioned so the face of the parent holding the child will not be visible.
|
|
Активный компаратор: Infants 6-8 month old
A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces.
The interfaces that will be used are: tight mask, the angled PediNeb, the B&B adapter, mask placed at 2 cm from the face, the PediNeb T-piece, and a capped corrugated tubing placed 2 cm away from the face.
|
A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces.
The infants will be videotape while they receive inhaled aerosol, and sound will be captured.
The camera will be positioned so the face of the parent holding the child will not be visible.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Acceptance of different interfaces while they receive inhaled therapy
Временное ограничение: within the 3 minutes of nebulization for 3 consecutive times with 5 minutes rest in between the each nebulization
|
The recordings will be analyzed by the 2 investigators for acceptance of the patient of the interface (likert scale 1 to 5: 5= Complete acceptance, 4= Accepting most of the time, 3= Accepting/rejecting half of the time, 2= Rejecting most of the time, 1= Complete rejection).
The data will be expressed as average of value assigned by each of the 2 researchers.
Analysis of variance for repeated measures followed by Tukey test will be used to compare the 2 endpoints.
A p value < 0.05 will be considered statistically significant
|
within the 3 minutes of nebulization for 3 consecutive times with 5 minutes rest in between the each nebulization
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Amounts of time with the aerosol well aligned with the nostrils during transnasal aerosol delivery
Временное ограничение: during the 3 minutes of nebulization
|
The recordings will be analyzed by the 2 investigators for percentage of time spent with aerosol aligned with the patient nostrils when using different interfaces
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during the 3 minutes of nebulization
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Соавторы и исследователи
Следователи
- Главный следователь: Katia El Taoum, MD, UAMS
- Главный следователь: Ariel Berlinski, MD, UAMS/ACHRI
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 202438
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.
продукт, произведенный в США и экспортированный из 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. .