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临床试验/CTRI/2025/01/079530
CTRI/2025/01/079530招募中不适用

Efficacy of Pre-extubation High Dose vs Low Dose Caffeine Administration For Success of Weaning in Mechanically Ventilated Newborns - A Randomized Controlled Trial

Yusuf Khairullah1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年2月25日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
128
试验地点
1
主要终点
To compare pre-extubation high and low dose caffeine administration in mechanically

研究概览

简要总结

Primary Objective - To compare pre-extubation high and low dose caffeine administration in mechanically

ventilated newborns for success of weaning in terms of :

  1. Re-intubation rates

  2. Duration of non-invasive ventilation needed

研究设计

研究类型
Interventional
分配方式
Other

入排标准

年龄范围
1.00 Day(s) 至 3.00 Month(s)(—)
性别
All

入选标准

  • All newborns admitted in the Neonatal intensive care unit.
  • All newborns with invasive mechanical ventilation of more than 48 hours.

排除标准

  • All healthy newborns in the Postnatal care unit are excluded.
  • All newborns with invasive mechanical ventilation of less than 48 hours.

结局指标

主要结局

To compare pre-extubation high and low dose caffeine administration in mechanically

时间窗: Newborns will be assessed daily i.e every 24 hourly till they are weaned completely off non invasive ventilation

ventilated newborns for success of weaning in terms of :

时间窗: Newborns will be assessed daily i.e every 24 hourly till they are weaned completely off non invasive ventilation

1. Re-intubation rates

时间窗: Newborns will be assessed daily i.e every 24 hourly till they are weaned completely off non invasive ventilation

2. Duration of non-invasive ventilation needed

时间窗: Newborns will be assessed daily i.e every 24 hourly till they are weaned completely off non invasive ventilation

次要结局

  • To compare the efficacy of high-dose & low-dose caffeine administration in reducing the(duration of supplemental oxygen requirement post-extubation in mechanically ventilated)

研究者

发起方
Yusuf Khairullah
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Yusuf Khairullah

N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital

研究点 (1)

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