microEEG for Neonatal Apnea, Bradycardia and Desaturation
Wireless Novel microEEG for Neonatal Apnea and Community Neurological Network
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Most preterm infants have episodes of apnea (cessation of breathing), bradycardia (low heart rate), and desaturations (low levels of oxygen in the blood) (ABD events). The resolution of ABD episodes depends to a large extent on the maturation of the central nervous system (CNS). The electroencephalogram (EEG) is a reliable and noninvasive tool for recording the electrical activity of the CNS. The relationship between ABD events and cerebral electrical activity has not been well investigated. The investigators seek to examine the relationship between EEG findings and the resolution of ABD events in the developing premature infant.
To investigate this relationship and obtain findings which are relevant to clinical care, a variety of obstacles need to be overcome. Among these obstacles is the high cost of standard EEG machines, inability of most standard machines to operate in electrically-noisy environments such as the NICU, and the absence of full-time coverage neurologists for prompt EEG interpretation. The investigators seek to determine the feasibility of obtaining an artifact-free EEG in the NICU with accurate detection of background rhythm abnormalities. The investigators will utilize an existing digital wireless telemetry unit, the "microEEG" for the NICU for this purpose. The microEEG device is specifically designed to overcome obstacles to standard EEG recording.
To address the shortage of trained pediatric neurophysiologists, the investigators will investigate the feasibility of a case management system for centralized EEG interpretation using off-site neurologists.
Finally, the investigators will examine the inter-rater reliability of EEG interpretation in the developing premature infant. This will allow the development of consensus guidelines for EEG interpretations.
Тип исследования
Регистрация (Ожидаемый)
Контакты и местонахождение
Места учебы
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New York
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Brooklyn, New York, Соединенные Штаты, 11203
- Рекрутинг
- State University of New York/Downstate Medical Center
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Контакт:
- Zachary Ibrahim, MD
- Номер телефона: 718-613-8442
- Электронная почта: zachary.Ibrahim@downstate.edu
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Контакт:
- Geetha Chari, MD
- Номер телефона: 9177600714
- Электронная почта: geetha.chari@downstate.edu
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Brooklyn, New York, Соединенные Штаты, 11212
- Рекрутинг
- Brookdale University Hospital and Medical Center,
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Контакт:
- Roger Kim, MD
- Номер телефона: 917-836-3613
- Электронная почта: rkim@brookdale.edu
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- gestational age (GA) 24-32 weeks
postnatal ages 0-30 days. The patients will be recruited upon manifesting one of the following
- apneas (cessation of breathing > 10 seconds) x2 in a 12 hour span
- bradycardias (HR < 100/min) x2 in 12 hours
- oxygen desaturations (<80%) x 2 in 12 hours
- a single ABD event that does not resolve with stimulation or an increase in fractional oxygen delivery (FiO2).
Exclusion Criteria:
- major malformations
- The infant has exposed dermis on the scalp due to immaturity
Any scalp skin lesions such as pustules, large abrasions The patient will be Withdrawn if
- Informed consent is withdrawn
- adverse events (i.e..scalp lesions) develop
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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EEG monitoring
All subjects enrolled in this observational study will undergo EEG monitoring using the microEEG device.
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microEEG is a miniature, wireless, and battery-powered EEG device used to obtain EEG recording in challenging environment. All infants have an initial EEG at study enrollment. Follow up microEEGs will be performed at approximately 2-4 week intervals, depending on the Corrected Gestational Age (CGA). If ABD events have not resolved at 34 weeks, an 8 hour recording will be performed prior to discharge or at 42 weeks CGA, whichever comes first. EEG will be assessed in 3 hour epochs. The EEG will be reviewed off line by two blinded neurologists and classified as normal or abnormal based on CGA and other findings. Follow up EEGs will be scored similarly, with emphasis on maturation. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Correlation between EEG background activity and resolution of Apnea, Bradycardia and Desaturation
Временное ограничение: Initial 8-9 hours EEG will be done upon study enrollment in the first 30 days of life.
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Primary outcome measure is to assess the background EEG activity in infants with ABD events and determine the relationship between abnormal initial EEG background activity and the resolution of ABD events at 34 weeks Corrected Gestational Age
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Initial 8-9 hours EEG will be done upon study enrollment in the first 30 days of life.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Rate of seizure activity.
Временное ограничение: From study enrollement to resolution of ABD events or 42 weeks corrected gesational age, whichever, comes first.
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All EEG recordings will be assessed by a pediatric neurophysiologist for seizure activity using standard clinical criteria.
Based on their findings the rate of seizure will be determined.
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From study enrollement to resolution of ABD events or 42 weeks corrected gesational age, whichever, comes first.
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Feasibility of microEEG recording in the NICU
Временное ограничение: From study enrollment (first 30 days of life) to resolution of ABD events or 42 weeks gesational age (whichever comes first)
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Assess the ability of neonatal staff to utilize the microEEG to obtain EEG in the NICU.
This will be done by measuring the percentage of completed recordings that are interpretable by a pediatric neurophysiologist.
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From study enrollment (first 30 days of life) to resolution of ABD events or 42 weeks gesational age (whichever comes first)
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Interrater reliability of neonatal EEG interpretation
Временное ограничение: From study enrollment (first 30 days of life) to resolution of ABD events or 42 weeks gesational age (whichever comes first)
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Assess the inter-rater reliability of neonatal EEG interpretations using data obtained in the course of the study.
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From study enrollment (first 30 days of life) to resolution of ABD events or 42 weeks gesational age (whichever comes first)
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Zachary Ibrahim, MD, State University of New York - Downstate Medical Center
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
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
Дополнительные соответствующие термины MeSH
- Патологические процессы
- Сердечные заболевания
- Сердечно-сосудистые заболевания
- Заболевания нервной системы
- Заболевания дыхательных путей
- Нарушения дыхания
- Неврологические проявления
- Признаки и симптомы, Респираторные
- Аритмии, Сердечные
- Осложнения беременности
- Осложнения акушерских родов
- Акушерские роды, преждевременные роды
- Апноэ
- Преждевременные роды
- Брадикардия
- Судороги
Другие идентификационные номера исследования
- 307016-7
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. .