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Идёт набор NCT07542301

Breathing Patterns in Infants Before and After Extubation

Наблюдательное Respiratory Distress Syndrome (RDS) PreTerm Neonate

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: Observation.
Кому может быть актуально
Состояния в реестре: Respiratory Distress Syndrome (RDS), PreTerm Neonate. Базовые параметры: 0 Days — 6 мес. · 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The primary objective of this study is to compare work of breathing indices before and after extubation in intubated premature infants admitted to the Christiana Care Neonatal Intensive Care Unit. The secondary objective is to compare the ability of work of breathing indices to predict extubation failure to routine spontaneous breathing tests (SBTs) in intubated premature infants admitted to the ChristianaCare NICU.

Подробное описание

For clinicians, the ability to accurately predict which infants will successfully extubate is essential. Doctors and nurses routinely use a combination of vital signs (heart rate, respiratory rate, oxygen saturations), physical examination and spontaneous breathing trials to determine a baby's readiness to have their breathing tube removed. A spontaneous breathing trial is routinely done in our NICU and involves reducing the support that the baby receives from the breathing machine while leaving the breathing tube in place. These methods do not always accurately predict which babies are ready to be extubated.

This prospective observational pilot study will measure work of breathing (how hard or how easy a baby breathes) before, during and after the routine spontaneous breathing test is done. The study will also measure work of breathing before and after removal of the breathing tube, if a baby's medical team decides the baby is ready to have their tube removed.

Work of breathing indices will be measured through respiratory inductive plethysmography (RIP). Soft elastic cloth bands will be placed around the baby's chest and abdomen. These bands measure how well the chest and abdomen work together when a baby breathes. We hypothesize that PneuRIP can predict extubation failure.

Вмешательства

  • Другое Observation
    Infants work of breathing will be observed through placement of soft elastic cloth bands on the infant's chest and abdomen. These bands measure how well the chest and abdomen work together when a baby breathes.

Первичные конечные точки

  • Work of breathing before and after extubation [Срок оценки: 25 minutes]
Вторичные конечные точки (1)
  • Ability of work of breathing indices to predict extubation failure. [Срок оценки: 25 minutes]

Критерии участия

Критерии включения

  • premature infants (born at ≤32 weeks gestation) who are intubated.
  • medical team is evaluating the baby for extubation readiness

Критерии исключения

  • Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of RIP measurements will be excluded.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • ChristianaCare Health Services, Inc. — Newark

Идентификаторы

NCT: NCT07542301 · DDD605736

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗