跳至主要内容
临床试验/NCT06550219
NCT06550219招募中不适用

Evaluation of Nasal Non Invasive Ventilation Modalities in Management of Neonates With Respiratory Distress Using Lung Ultrasound

Alexandria University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Duration of non-Invasive ventilation (NIV)

研究概览

简要总结

This study aims to evaluate the effect of non-invasive ventilation (nIPPV)

, (nCPAP), and nasal high flow cannula (NHFC) as a primary mode of ventilation in preterm neonates <37 gestational week with moderate to severe RD using LUS as regard: I. Primary outcomes: Duration of non-Invasive ventilation. II. Secondary outcomes: Evaluation LUS over the 1 st 7 days of life or weaning from ventilation. Need for intubation and invasive ventilation. Duration of respiratory support. Need for surfactant. Oxygen saturation index and oxygen index. Broncho-pulmonary dysplasia; grade. Duration of hospital stay

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Hour 至 24 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm <37 wk. gestational age admitted to the NICU with spontaneous breathing and clinical manifestations of RD (tachypnea, nasal flaring, intercostal and subcostal retraction and or grunting).

排除标准

  • Obvious major congenital abnormalities.
  • Any of the baby intubated for resuscitation or for other reasons.
  • Neonates need invasive mechanical ventilation.
  • Pulmonary hemorrhage.
  • Severe cardiovascular instability.
  • Cardiopulmonary arrest needing prolonged resuscitation.
  • Birth asphyxia (one-minute Apgar score ≤ 3).
  • Major cardiac diseases (not including patent ductus arteriosus).

结局指标

主要结局

Duration of non-Invasive ventilation (NIV)

时间窗: First two weeks of life.

Describe the days of non-invasive ventilation , described in days number.

次要结局

  • Oxygen saturation index (OSI).(first one weeks of life.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Mohamed Farag

Assistant professor

Alexandria University

研究点 (2)

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