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临床试验/CTRI/2023/05/052333
CTRI/2023/05/052333已完成3 期

A STUDY TO COMPARE NON-INVASIVE(34°C) AND INVASIVE(37°C) MODE OF HUMIDIFICATION DURING NON-INVASIVE VENTILATION IN TERM NEONATE

Dr Srinivas Murki1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2023年8月5日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
104
试验地点
1
主要终点
Total duration of respiratory support during admission to the NICU

研究概览

简要总结

All term infants admitted with respiratory distress and requires non invasive mode of ventilation(either CPAP or HFNC) will be given non invasive mode of humidification which is low temperature(34C) and low humidity(>30mg/L) in the intervention arm and Invasive mode of humidification i.e. high temperature(37C) , high humidity(44mg/L) in control arm. both thiese  modes of humidification are present on all standard humidifier (Fischer and Packel MR 850 i.n this case).  Both modes will supply absolute humidity of >30mg/L and temperature of > 30C which is usual recommendation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
1.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • Term infants admitted in NICU requiring primary non invasive respiratory support.

排除标准

  • 1.Babies with congenital anomalies 2.Syndromic babies 3.Neonates receiving therapeutic hypothermia 4.Neonates in whom primary mode of respiratory support is invasive.

结局指标

主要结局

Total duration of respiratory support during admission to the NICU

时间窗: Till hospital discharged.

次要结局

  • 1. Ventilator Associated Pneumonia(2. Humidity and Temperature at nasopharyngeal level (thermohygrometer))

研究者

发起方
Dr Srinivas Murki
申办方类型
Other [Thesis Guide]

研究点 (1)

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