跳至主要内容
临床试验/CTRI/2024/04/066150
CTRI/2024/04/066150尚未招募2 期

Noninvasive high frequency oscillatory ventilation versus Noninvasive intermittent positive pressure ventilation as a primary respiratory support in preterms with respiratory distress syndrome- A Randomized Control Trial

Dr Sonali Amol Avale1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年5月7日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Need for Invasive Mechanical ventilation in the first 72 hours of life in preterm randomized to the three groups

研究概览

简要总结

Invasive ventilation (IV) is a key procedure to reduce respiratory  mortality and morbidity in preterm infants with  respiratory distress syndrome (RDS). However, it is associated with the increased risks of bronchopulmonary dysplasia (BPD) ,re-hospitalization, and brain injury among the survivors .Nasal high-frequency oscillatory ventilation (NHFOV) appears to combine the advantages of continuous distending pressure and non-invasive ventilation without need for synchronization  and may reduce the incidence of intubation in preterm infants with RDS. A multicentre study has indicated that NHFOV is related to the reducednumbers of apnea, bradycardia, and oxygen desaturation as a remedial measure after failing other noninvasive modes in preterm infants. Hence the purpose of this study is to compare efficacy of noninvasive high frequency ventilation versus non invasive intermittent positive pressure ventilation in preterms with respiratory distress syndrome.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
0.00 Day(s) 至 1.00 Day(s)(—)
性别
All

入选标准

  • Gestational age (GA) is between 26 and less than 34 weeks.
  • GA will be determined by dates or a dating ultrasound.
  • If not available- New Ballards score will be used to determine gestational age Diagnosis of RDS -The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring, and or grunting) within the first 1 hour of life.
  • Chest Xray will be done within 1 hour of life .
  • Informed parental consent.

排除标准

  • 1.Any baby intubated for resuscitation or for other reasons.
  • Major congenital malformations or known complex congenital heart disease.
  • Refusal to consent.

结局指标

主要结局

Need for Invasive Mechanical ventilation in the first 72 hours of life in preterm randomized to the three groups

时间窗: first 72 hours of life

次要结局

  • 1. Days of hospitalization,(2. Days on NIV,)

研究者

发起方
Dr Sonali Amol Avale
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sonali Amol Avale

Government Medical college , Sambhaji Nagar

研究点 (1)

Loading locations...

相似试验