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临床试验/CTRI/2024/06/068826
CTRI/2024/06/068826尚未招募3 期

Nasal continuous positive airway pressure with RAM cannula versus nasal mask in reducing the need for invasive mechanical ventilation in preterm neonates

Dr Nikhil Srivastav1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
210
试验地点
1
主要终点
Need for invasive mechanical ventilation within 72 hours of nCPAP application

研究概览

简要总结

Following thesis is on comparing nasal interface RAM cannula and nasal mask for application of nasal continuous positive airway pressure (nCPAP) in preterm neonates less than 34 weeks of gestation with respiratory distress within 6 hours of life. nCPAP is a type of non invasive ventilation. Both these interfaces are currently in use in our institute in neonatal intensive care unit. This thesis is about comparing both the interfaces about their failure rate and neonantes requiring invasive mechanical ventilation as primary objective and secondary objective is incidence of nasal trauma in both the interfaces. Inclusion criteria will be all inborn neonates with gestation age less than 34 weeks having respiratory distress syndrome within 6 hours of life. Each neonate will be given nCPAP via RAM cannula or nasal mask and will be followed for 72 hours of life. Exclusion criteria will be major congenital malformations, including chromosomal anomalies, which interfere with respiration or putting the newborn on nCPAP and severe perinatal birth asphyxia with 5 min Apgar score less than 3.

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 3.00 Day(s)(—)
性别
All

入选标准

  • Inborn preterm neonates less than 34 weeks of gestation with respiratory distress syndrome within 6 hours of life.

排除标准

  • Major congenital malformation, including chromosomal anomalies, which interfere with respiration or putting the newborn on nCPAP and severe perinatal asphyxia with 5 min Apgar score less than 3.

结局指标

主要结局

Need for invasive mechanical ventilation within 72 hours of nCPAP application

时间窗: 72 hours

次要结局

  • Incidence and severity of Nasal trauma(72 hours)

研究者

发起方
Dr Nikhil Srivastav
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nikhil Srivastav

Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi

研究点 (1)

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