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临床试验/CTRI/2024/09/073484
CTRI/2024/09/073484尚未招募不适用

Efficacy of Nasal high frequency oscillatory ventilation (nHFOV) VERSUS Synchronised non-invasive positive pressure ventilation (SNIPPV) VERSUS Nonsynchronised non-invasive positive pressure ventilation (NS-NIPPV) as a post extubation respiratory support in preterm neonates (≥ 28 WEEKS OF GESTATION) admitted in a tertiary care centre – A 3 ARM RANDOMIZED CONTROL TRIAL

Neonatology Departmental Fund1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2024年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
129
试验地点
1
主要终点
Extubation failure within 72 hours

研究概览

简要总结

We hypothesize that nHFOV, SNIPPV & NS-NIPPV are equally efficacious as a mode of respiratory support after extubation & reduce the need for endotracheal re-intubation. Comparison of nHFOV with NIPPV is still in its infancy and more studies are required to come to a consensus statement. In this study we have planned to compare nHFOV versus SNIPPV versus NS-NIPPV as a post extubation respiratory mode in preterm neonates more than equal to 28 weeks of gestational age admitted in a tertiary care centre from eastern India which to the best of our knowledge has not been done so far.

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
7.00 Month(s) 至 11.00 Month(s)(—)
性别
All

入选标准

  • Infants born ≥28 weeks of gestation
  • Inborn babies upto postnatal age 15 days
  • Mechanically ventilated for at least 12 hrs.

排除标准

  • Infant born at less than 28 weeks of gestational age
  • Outborn babies
  • Major congenital anomalies or suspected chromosomal anomalies
  • Upper airway malformations
  • Severe perinatal asphyxia.

结局指标

主要结局

Extubation failure within 72 hours

时间窗: Extubation failure within 72 hours

次要结局

  • 1. Bronchopulmonary dysplasia (BPD)(2. Mortality (all causes within NICU stay/ upto 28)

研究者

发起方
Neonatology Departmental Fund
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sk samim

IPGMER & SSKM HOSPITAL

研究点 (1)

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