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Идёт набор NCT05908227

Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants

Без фазы С лечением Respiratory Distress Syndrome

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: NHF high, NHF low, NCPAP.
Кому может быть актуально
Состояния в реестре: Respiratory Distress Syndrome. Базовые параметры: 23 Weeks — 31 Weeks · 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
Германия, Швейцария
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

Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants (MASTER Trial)

Обзор

Premature babies often need help breathing for a longer period of time. Traditionally, this is done with a breathing aid called NCPAP (nasal continuous positive airway pressure). This treatment is safe and effective, but it is very time-consuming and can sometimes have side effects. In the present research project, the investigators want to find out whether another type of breathing aid called NHF (nasal high flow therapy) is just as effective for stable premature babies. The investigators suspect that NHF is just as effective, but easier to use and more comfortable.

Подробное описание

This is a multi center parallel group three arm randomized controlled clinical trial investigating cardiorespiratory stability in stable preterm infants receiving NHF.

Currently, NCPAP remains the gold standard for administration of prolonged non-invasive ventilatory support in very preterm infants. NHF is a promising method for tailored, less invasive long-term ventilatory support for preterm infants. If ventilatory support with NHF is similarly effective to conventional NCPAP in stable preterm infants, clinicians are likely to adopt this method for widespread clinical use because of its improved comfort and potential other benefits. Primary aim of this trial is to examine cardiorespiratory stability in preterm infants treated with two commonly used NHF flowrates (Interventional group 1 and 2) in comparison to NCPAP (Comparator). Secondary aim is to examine potential comfort-related beneficial effects of NHF.

Вмешательства

  • Другое NHF high
    Nasal high flow therapy 8L/min.
  • Другое NHF low
    Nasal high flow therapy 6L/min.
  • Другое NCPAP
    Nasal continuous positive airway pressure 6 cm H20

Первичные конечные точки

  • Treatment failure [Срок оценки: 24 hours]
Вторичные конечные точки (12)
  • Apneas and bradycardias [Срок оценки: 24 hours]
  • Respiratory rate (RR) [Срок оценки: 24 hours]
  • Heart rate (HR) [Срок оценки: 24 hours]
  • Oxygen saturation (SpO2) and fraction of inspired oxygen (FiO2) [Срок оценки: 24 hours]
  • Frequency of any treatment failure [Срок оценки: Individual study duration: estimated to be between a minimum of 7 days to an (estimated) maximum of 10 weeks.]
  • Rescue NCPAP [Срок оценки: Individual study duration: estimated to be between 7 days to 10 weeks.]
  • Postmenstrual age (PMA) off positive pressure support [Срок оценки: Estimated to be at a PMA of approximately 29 to 34 weeks.]
  • Postmenstrual age (PMA) off FiO2 > 0.21 [Срок оценки: Estimated to be at a PMA between approximately 28 to 34 weeks.]
  • Postmenstrual age (PMA) at discharge [Срок оценки: Estimated to be at a PMA of approximately 38-40 weeks.]
  • Cerebral oxygen saturation (cRSO2) 1 hour before until 3 hours after start of the intervention [Срок оценки: 4 hours]
  • Time spent <55% cRSO2 1 hour before until 3 hours after start of the intervention [Срок оценки: 4 hours]
  • Cerebral oxygen saturation (cRSO2) 1 hour before until 3 hours after cessation of the intervention [Срок оценки: 4 hours]

Критерии участия

Критерии включения

Inclusion if all apply.

  • Preterm infants up to 31+6 weeks GA admitted to the Division of Neonatology at Inselspital Bern, Switzerland or Division of Neonatology at the University Medical Center of the Johannes Gutenberg-University Mainz, Germany (inborn or outborn)
  • >2nd day of life (defined as date day)
  • Stable on NCPAP 6 cm H2O for ≥ 24 hours, defined as:
  • ≤ 2 apneas with concomitant bradycardias (<100/min) per hour for the previous 6 hours
  • FiO2 ≤ 0.3 and not increasing
  • No significant chest recessions (Silverman Score < 5)
  • Respiratory rate ≤ 60/min
  • No need for intermittent positive pressure ventilation
  • Parents with an age 18+ years
  • Written parental informed consent (or other legal representative)

Критерии исключения

Exclusion if any applies.

  • Significant fetal anomalies
  • Primary palliative care
  • Stable on NCPAP 6 cm H2O according to stability criteria for more than 120 hours

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
Другое

Центры проведения

Германия · 1 центр
  • University Medical Center of the Johannes Gutenberg-University Mainz — Mainz
Швейцария · 1 центр
  • Department of Pediatrics, Inselspital — Bern

Публикации

  • Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available. PMID 11401896

Идентификаторы

NCT: NCT05908227 · 2022-02287

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗