Lung Ultrasound-Guided Respiratory Management in Infants
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: Lung ultrasound-guided respiratory management.
- Кому может быть актуально
- Состояния в реестре: Neonatal Respiratory Failure. Базовые параметры: 0 лет — 1 год · 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Lung Ultrasound-Guided Respiratory Management in Infants: A Single-Center Randomized Controlled Trial
Обзор
This single-center randomized controlled study will compare lung ultrasound-guided respiratory management with standard clinical care in infants requiring respiratory support. The primary outcome measure is length of NICU stay.
Подробное описание
Infants, especially premature infants, frequently require respiratory support in the neonatal intensive care unit (NICU). Lung ultrasound is a bedside, radiation-free tool that can assess lung aeration and guide respiratory management, but its effect on clinical outcomes has not been evaluated in a U.S. randomized trial.
This single-center randomized controlled study will compare lung ultrasound-guided respiratory management with standard clinical care in premature infants requiring respiratory support. In the intervention group, lung ultrasound scores will guide surfactant administration, weaning non-invasive respiratory support, and weaning from non-invasive respiratory support to room air using predefined thresholds. The control group will use standard care to guide surfactant administration, weaning non-invasive respiratory support, and weaning from non-invasive respiratory support to room air.
The primary outcome is length of NICU stay. Secondary outcomes include duration of respiratory support, time on non-invasive respiratory support, time to successful weaning to room air, need for re-intubation, surfactant dosing, and mortality prior to discharge. This study aims to determine whether lung ultrasound-guided management can improve respiratory care and reducive hospital length of stay in infants requiring respiratory suppport.
Вмешательства
- Процедура Lung ultrasound-guided respiratory management
Scheduled lung ultrasounds are performed to guide decisions about surfactant administration, non-invasive respiratory support weaning, and transition to room air using predefined lung ultrasound score thresholds.
Первичные конечные точки
- Length of NICU stay (days) [Срок оценки: From date of NICU admission to date of hospital discharge up to one year]
Вторичные конечные точки (7)
- Duration of any respiratory support [Срок оценки: From date of initiation of respiratory support to date of discontinuation of respiratory support, up to one year]
- Duration of non-invasive respiratory support [Срок оценки: From date of initiation of non-invasive respiratory support to date of discontinuation of non-invasive respiratory support up to one year.]
- Time to successful weaning to room air [Срок оценки: From date of initiation of respiratory support to date of sustained room air without support for at least 48h, up to one year.]
- Weaning failure [Срок оценки: From date of weaning respiratory support, to date of re-escalation of respiratory support if needed, up to 72 hours]
- Need for reintubation [Срок оценки: From date of extubation, to date of reintubation, up to 72 hours.]
- Number of surfactant doses administered [Срок оценки: Number of surfactant doses quantified over the course through study completion, up to an average of 1 year.]
- Mortality prior to discharge [Срок оценки: From date of birth until the date of death from any cause, assessed up to one year.]
Критерии участия
Критерии включения
- Infants admitted to the Tufts Medical Center NICU
- Requiring invasive or non-invasive respiratory support
- Requiring surfactant therapy
- Parental or guardian informed consent obtained
Критерии исключения
- Major congenital anomalies
- Known chromosomal abnormalities
- Congenital diaphragmatic hernia
- Decision for comfort care
- Surfactant administered prior to transfer from outside hospital (only excluded for surfactant decisions)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Публикации
- Brat R, Yousef N, Klifa R, Reynaud S, Shankar Aguilera S, De Luca D. Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure. JAMA Pediatr. 2015 Aug;169(8):e151797. doi: 10.1001/jamapediatrics.2015.1797. Epub 2015 Aug 3. PMID 26237465
- Gathright M, Chacko A, Paulson M, O'Connor B, Mansky R, Lasarev M, Cowan E, Hulse W, Monroe E, Alfaro E, Baker M, Bauer AS, Diego E. An Evaluation of Vital Signs in Intubated Neonates Undergoing Lung Point-of-Care Ultrasound in the Neonatal Intensive Care Unit. J Clin Ultrasound. 2026 Jun;54(5):1072-1078. doi: 10.1002/jcu.70161. Epub 2025 Dec 22. PMID 41427513
Идентификаторы
NCT: NCT07386041 · STUDY00006737