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Идёт набор NCT07513051

DIaphragmatic Swing According to Cpap Flow Output in NEOnates (DISCONEO)

Без фазы С лечением Neonatal Respiratory Distress

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: CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP, VF-CPAP; VF-CPAP; CF-CPAP; CF-CPAP, CF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP, VF-CPAP; CF-CPAP; CF-CPAP; VF-CPAP.
Кому может быть актуально
Состояния в реестре: Neonatal Respiratory Distress. Базовые параметры: 72 Hours — 10 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
Франция
Следующий шаг
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Официальное название

Diaphragmatic Activity During Constant or Variable Flow CPAP in Neonates: a Non-inferiority, Randomized, Alternating Treatments Trial

Обзор

The hypothesis behind the study is that the performance of constant flow CPAP (Continuous Positive Airway Pressure) devices (CF-CPAP) is not inferior to that of variable flow CPAP devices (VF-CPAP) in terms of respiratory efforts assessed by swing EAdi (Electrical activity of diaphragm) in a population of premature neonates born ≤ 32 weeks of gestational age.

Подробное описание

CPAP is an indispensable tool in NICU (neonatal intensive care unit ) to recruit and maintain lung volume, to reduce airway resistances and increase pulmonary compliance. However, the variety of existing pressure generators (constant-flow=CF-CPAP or variable flow=VF-CPAP) and interfaces (prongs, masks) makes evidence-based clinical decisions difficult. Considering the persisting controversy regarding the comparative efficacy of CF-CPAP versus VF-CPAP, new less- or non-invasive tools such diaphragmatic electrical activity (EAdi) monitoring may allow to better evaluate their impact on respiratory efforts.

Our hypothesis is that CF-CPAP devices with nasal mask are not inferior to VF-CPAP devices with nasal mask regarding respiratory efforts assessed by observed swing EAdi in a population of neonates born at ≤ 32 weeks gestational age.

Вмешательства

  • Устройство CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP
    On day 1 : 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording). On day 2 : 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording).
  • Устройство VF-CPAP; VF-CPAP; CF-CPAP; CF-CPAP
    On day 1 : 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording). On day 2 : 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording).
  • Устройство CF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP
    On day 1 : 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording). On day 2 : 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording).
  • Устройство VF-CPAP; CF-CPAP; CF-CPAP; VF-CPAP
    On day 1 : 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording). On day 2 : 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording).

Первичные конечные точки

  • Mean swing EAdi (µV) [Срок оценки: Continuous recording during 1 hour and 30 minutes after a 30 minutes wash-out period for each ventilation period]
Вторичные конечные точки (12)
  • COMFORTneo score [Срок оценки: At the beginning and at the end of each ventilation period, up to 2 hours]
  • Transcutaneous CO2 pressure TcPCO2 (mm Hg) [Срок оценки: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation period]
  • Heart rate beats per minute (bpm) [Срок оценки: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation]
  • Respiratory rate cycles/minute [Срок оценки: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation]
  • SPO2 (%) [Срок оценки: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation]
  • Mean arterial blood pressure (mm Hg) [Срок оценки: At the beginning and at the end of each ventilation period, up to 2 hours]
  • Mean phasic peak EAdi (µV) [Срок оценки: Continuous recording during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation period]]
  • Mean tonic peak EAdi (µV) [Срок оценки: Continuous recording during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation period]
  • CPAP level (cm H20) [Срок оценки: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation]
  • CPAP flow if variable flow CPAP (l/min) [Срок оценки: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation]
  • FiO2 (%) [Срок оценки: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation]
  • Number of events of Bradycardia < 100 bpm [Срок оценки: During each ventilation period, up to 2 hours]

Критерии участия

Above mentioned age limits (72 hours to 10 weeks) apply to postnatal age. Inclusion criteria apply to gestational age at birth and postmenstrual age (in weeks).

Критерии включения

  • Neonates born at ≤ 32 weeks GA (gestational age)
  • Hospitalized in our tertiary hospital NICU (Neonatal intensive care unit)
  • Receiving CPAP since > 24 hours at inclusion
  • Equipped with EAdi catheters.
  • Aged more than 72 hours
  • With parental consent
  • Affiliated to or benefiting from a social security system

Non inclusion Criteria:

  • More than 1 episode of apnea / hour and/or hypercapnic acidosis (defined as pH < 7.20 and/or pCO2 > 65)
  • FiO2 > 60%
  • Neonatal ARDS (acute respiratory distress syndrome) according to the Montreux definition
  • Pneumothorax/ pneumomediastinum
  • Nasal lesions contraindicating nasal noninvasive ventilation
  • Major congenital malformation/Chromosomopathies
  • Congenital neuromuscular diseases
  • Hemodynamic instability

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Франция · 1 центр
  • Centre Hospitalier Intercommunal de Créteil — Créteil

Идентификаторы

NCT: NCT07513051 · DISCONEO

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗