Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes
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: Poractant alfa (Curosurf®) - 1-minute administration, Poractant alfa (Curosurf®) - 5-minute administration.
- Кому может быть актуально
- Состояния в реестре: Neonates and Preterm Infants, Infant Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal, Surfactant. Базовые параметры: 0 мес. — 72 Hours · 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
- Австрия
- 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
Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minute Versus 5 Minutes - a Prospective Randomised-controlled Phase IV Trial - A Randomised Clinical Trial on Influence of Duration of Surfactant Administration on Stabilisation of Routine Monitoring Parameters and Cerebral Tissue Oxygen Saturation Monitoring in Preterm Neonates < 28 Weeks of Gestational Age
Обзор
Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA) technique. However, the optimal duration of surfactant instillation during LISA has never been systematically evaluated. Rapid instillation may provoke transient hypoxia and bradycardia, while slower administration might improve physiological stability and cerebral oxygenation. This randomised controlled trial investigates whether the duration of surfactant administration (1 minute versus 5 minutes) affects cerebral and systemic oxygen stability in extremely preterm neonates (\< 28 weeks).
Подробное описание
The SurfStab I Trial is a single-centre, randomised, controlled, phase IV trial conducted at the Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Austria.
Infants born before 28 weeks of gestation and requiring surfactant therapy via the LISA technique will be randomised (1:1) to receive poractant alfa administered over either 1 minute or 5 minutes. The intervention duration represents two clinically accepted timeframes within current guideline recommendations.
Cerebral oxygenation will be monitored continuously using near-infrared spectroscopy (NIRS) from 5 minutes before to 3 hours after the procedure. The primary outcome is the maximal change in cerebral regional tissue oxygen saturation (crSO₂) from baseline (=5 minutes before starting the LISA procedure \[insertion of the LISA catheter\]) till 15 minutes after the LISA procedure (=removal of the LISA catheter). Secondary outcomes include changes in peripheral oxygen saturation (SpO₂), heart rate (HR), mean arterial blood pressure (MABP), frequency and duration of hypoxic or bradycardic episodes, and the need for repeated surfactant administration or invasive ventilation.
The total sample size is 76 infants (38 per arm). The study will provide evidence on whether slower surfactant administration improves physiological stability and cerebral oxygenation.
Вмешательства
- Препарат Poractant alfa (Curosurf®) - 1-minute administration
Poractant alfa (Curosurf®, Chiesi Pharmaceuticals) administered intratracheally via the Less Invasive Surfactant Administration (LISA) technique over 1 minute. The surfactant is instilled manually through a thin catheter under direct laryngoscopy while the infant remains on continuous positive airway pressure (CPAP) and spontaneous breathing. Pre-specified criteria for aborting the LISA procedure are prolonged bradycardia (HR \< 80 bpm) and/or arterial hypoxia (SpO2 \< 80%) over 60 seconds dur - Препарат Poractant alfa (Curosurf®) - 5-minute administration
Poractant alfa (Curosurf®, Chiesi Pharmaceuticals) administered intratracheally via the Less Invasive Surfactant Administration (LISA) technique over 5 minute. The surfactant is instilled manually through a thin catheter under direct laryngoscopy while the infant remains on continuous positive airway pressure (CPAP) and spontaneous breathing. Pre-specified criteria for aborting the LISA procedure are prolonged bradycardia (HR \< 80 bpm) and/or arterial hypoxia (SpO2 \< 80%) over 60 seconds dur
Первичные конечные точки
- Change in cerebral oxygenation (crSO₂) during and after LISA [Срок оценки: From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter]
Вторичные конечные точки (12)
- Change in arterial oxygen saturation (SpO₂) during and after LISA [Срок оценки: From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter]
- Change in heart rate (HR) during and after LISA [Срок оценки: From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter]
- Change in crSO2 up to three hours after LISA [Срок оценки: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure]
- Change in SpO2 up to three hours after LISA [Срок оценки: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure]
- Change in HR up to three hours after LISA [Срок оценки: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure]
- Change in mean arterial blood pressure (MABP) up to three hours after LISA [Срок оценки: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure]
- Amount of bradycardia [Срок оценки: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure]
- Amount of cerebral hypoxia [Срок оценки: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure]
- Amount of systemic hypoxia [Срок оценки: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure]
- Amount of supplemental oxygen [Срок оценки: Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure]
- Need for repeat surfactant administraiton [Срок оценки: Within 48 hours after first LISA procedure]
- Need for invasive ventilation [Срок оценки: Within 48 hours after first LISA procedure]
Критерии участия
Критерии включения
- Preterm neonate <28+0 weeks (gestational age up to 27 weeks and 6 days)
- Indication of surfactant administration via the LISA method
- Postnatal age < 72 hours
Критерии исключения
- Invasive ventilation, indication of INSURE procedure
- Severe pulmonary or cardiac malformation affecting oxygenation or congenital cerebral malformation
- Preexisiting diagnose of any IVH > grade 2 or PVH.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Австрия · 1 центр
- Medical University of Graz, Division of Neonatology, Department of Pediatrics and Adolesce — Graz
Идентификаторы
NCT: NCT07261787 · SurfStab I Trial · 2025-522754-39-00