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临床试验/CTRI/2026/02/103932
CTRI/2026/02/103932尚未招募不适用

Comparison of Different Types of Cannula with Long and Narrow Tubing (CLNT) in the Administration of Non-Invasive Ventilation (NIV) in Preterm Neonates: An Exploratory Randomized Controlled Trial

KASTURBA MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年3月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1

研究概览

简要总结

This study is an exploratory randomized controlled trial conducted in the neonatal intensive care unit to compare the safety and efficacy of different cannula with long and narrow tubing interfaces for delivery of non invasive ventilation in preterm neonates. Preterm neonates with birth weight more than 1000 grams who require non invasive ventilation as primary respiratory support will be enrolled after obtaining informed consent. Eligible neonates will be randomized to receive non invasive ventilation using either RAM cannula or Optiflow Junior nasal cannula. Both groups will be managed according to standard NICU protocols.

The primary outcome is non invasive ventilation failure within 72 hours of initiation. Secondary outcomes include treatment failure after 72 hours, effectiveness of pressure delivery, incidence and severity of nasal injury, ease of use of the interface by nursing staff, need for surfactant, complications of prematurity, duration of respiratory support, length of hospital stay, and mortality before discharge. The study aims to generate pilot data comparing two commonly used cannula interfaces and to guide future larger multicenter trials and standardization of interface selection in neonatal intensive care units.

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 28.00 Day(s)(—)
性别
All

入选标准

  • Preterm neonates with birth weight more than 1000 gm for whom Non Invasive Ventilation (NIV) is being initiated as primary non-invasive respiratory support soon after birth.

排除标准

  • Neonates with major congenital malformations/orofacial anomalies/ suspected chromosomal anomaly 2)Extramural babies.

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr. Patlolla Shanti

Kasturba Medical College, Manipal

研究点 (1)

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