跳至主要内容
临床试验/CTRI/2012/12/003241
CTRI/2012/12/003241招募中不适用

Comparison of non invasive modalities -nasal intermittent positive pressure ventilation and nasal continuous positive pressure ventilation in preterm neonates - RCT

未提供1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年12月10日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
The primary outcome is ‘failure’ of noninvasive respiratory support, and necessitating intubation and mechanical ventilation within 48 hours of initiation of non invasive ventilator support.

研究概览

简要总结

The preterm neonates with respiratory distress are being randomized and allocated the intervention after obtaining consent from parents. 100 neonates have been recruited and successfully enrolled and been followed according to the protocol. The preterm neonate with respiratory distress of downe’s score more than or equal to 3 within 6 hours of life is enrolled after stratified block randomization to NIPPV or NCPAP. The demopgraphic data and the downe’s score and the initial settings of ventilation are recorded every 4th hourly. The need for mechanical ventilation is monitored for first 48hrs of Non Invasive Ventilation(NIV) and the outcome is recorded. The total duration of NIV support is also recorded and evaluated. The abdominal girth and rate of feeding is also recorded 4th hourly and daily respectively. ROP evaluation and NSG is being done for each neonate as per NICU protocol.

Similarly the preterm neonates requiring mechanical ventilation initially and extubated to NIV are also monitored after enrolling and randomization to study.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Not Applicable

入排标准

年龄范围
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • All preterm and late preterm neonates (<37 weeks) with Downe’s score ≥
  • Age limit is 0- 28 days of life.

排除标准

  • 1.Neonates with congenital cyanotic heart disease.
  • 2.Neonates with major congenital malformations.
  • 3.Neonates with air leak syndromes.

结局指标

主要结局

The primary outcome is ‘failure’ of noninvasive respiratory support, and necessitating intubation and mechanical ventilation within 48 hours of initiation of non invasive ventilator support.

时间窗: TIME LIMIT IS 48 Hrs

次要结局

  • 1. duration of respiratory support(2.duration of NICU stay)

研究者

发起方
未提供

研究点 (1)

Loading locations...

相似试验