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Идёт набор NCT04777760

Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)

— Наблюдательное Respiratory Distress Syndrome Preterm Birth Acute Respiratory Distress Syndrome Surfactant Dysfunction

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: one dose of surfactant replacement, two and more doses of surfactant replacement.
Кому может быть актуально
Состояния в реестре: Respiratory Distress Syndrome, Preterm Birth, Acute Respiratory Distress Syndrome, Surfactant Dysfunction. Базовые параметры: 1 Minute — 24 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
Китай
Следующий шаг
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Обзор

In preterm infants with neonatal respiratory distress syndrome (NRDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal mortality. Nowadays, PS is commonly used in newborn infants with respiratory distress, but the incidences of bronchopulmonary dysplasia(BPD) and/or death are inconsistent. The result indicates that not all preterm infants with respiratory distress can be beneficial from PS. In 2017, the international neonatal ARDS (NARDS) collaborative group provides the first consensus definition for NARDS. And whether or not PS being beneficial for preterm infants with NARDS remains unknown.

Подробное описание

To date, PS is not recommended to adult and pediatric ARDS. Meantime, systematic review indicates that PS does not demonstrate statistically significant beneficial effects on reducing the mortality and the rate of BPD in term and late preterm infants with meconium aspiration syndrome(MAS). Therefore, a reasonable speculation is that preterm infants with NARDS do not benefit from one dose of PS. And the speculation can explain why not all preterm infants with respiratory distress can be beneficial from PS. In the era of pre-NARDS, the preterm infants fulfilling the definition of NARDS may have been considered as NRDS in the first three days after birth.

According to the diagnostic criteria of NARDS, a key procedure for diagnosis of NARDS is to exclude the newborn infants with NRDS. But no detailed procedures are available to differentiate NRDS from NARDS.

Вмешательства

  • Препарат one dose of surfactant replacement
    the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant
  • Препарат two and more doses of surfactant replacement
    the preterm infants diagnosed with NRDS and/or NARDS will be administrated with two and more doses of surfactant

Первичные конечные точки

  • bronchopulmonary dysplasia(BPD) [Срок оценки: at 36 weeks' gestational age or before discharge from hospital]
  • death [Срок оценки: at 36 weeks' gestational age or before discharge from hospital]
  • BPD and/or death [Срок оценки: at 36 weeks' gestational age or before discharge from hospital]
  • the predictive powers of one dose of surfactant to diagnose NRDS [Срок оценки: seven days after birth]
  • the predictive powers of two and more doses of surfactant to diagnose NARDS [Срок оценки: seven days after birth]
Вторичные конечные точки (6)
  • intraventricular hemorrhage(IVH) [Срок оценки: before discharge or 36 weeks' gestational age]
  • air leak [Срок оценки: at 36 weeks' gestational age or before discharge from hospital]
  • periventricular leukomalacia(PVL) [Срок оценки: at 36 weeks' gestational age or before discharge from hospital]
  • necrotizing enterocolitis(NEC) [Срок оценки: at 36 weeks' gestational age or before discharge from hospital]
  • patent ductus arteriosis(PDA) [Срок оценки: at 36 weeks' gestational age or before discharge from hospital]
  • late-onset sepsis(LOS) [Срок оценки: at 36 weeks' gestational age or before discharge from hospital]

Критерии участия

Критерии включения

Eligibility requirements for neonates were as follows:

  • The gestational age is less than 37 weeks and admitted to neonatal intensive care unit(NICU) in 24 h after birth
  • The neonates will be diagnosed with NRDS or NARDS
  • The neonates will be at least administrated one dose of surfactant

Критерии исключения

one of the following criteria will be needed

  • major congenital anomalies
  • chromosomal abnormalities
  • upper respiratory tract abnormalities

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Chen — Чунцин

Идентификаторы

NCT: NCT04777760 · surfactant for NRDS and ARDS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗