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临床试验/CTRI/2025/11/098134
CTRI/2025/11/098134
尚未招募
不适用

A randomised controlled trial comparing the efficacy of Bubble Continuous Positive Airway Pressure (B-CPAP) and Ventilator Continuous Positive Airway Pressure (V-CPAP) in preterm neonates with respiratory distress

Dr Devi Pilakkal Gangadharan1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年12月23日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Dr Devi Pilakkal Gangadharan
入组人数
160
试验地点
1
主要终点
To compare the CPAP success rate between Bubble CPAP and Ventilator CPAP as the initial mode of respiratory support for preterm babies with respiratory distress.

概览

简要总结

Preterm birth remains a major global health issue, causing around 965000 neonatal deaths and 125000 deaths in children under five each year. In 2020, 13.8 million babies were born prematurely, with South East Asia and sub Saharan Africa bearing the highest burden. The early neonatal period is particularly critical, with most deaths occurring during labour or within 24 hours of birth. Prematurity and low birth weight are leading causes of neonatal mortality.

Respiratory distress is the most common complication in preterm infants, often resulting from conditions such as respiratory distress syndrome, congenital pneumonia, or pulmonary hypoplasia. A large cohort study from India and Pakistan found that 23 per cent of preterm neonates died within 28 days, with major causes including maternal hypertension, placental malperfusion, chorioamnionitis, intrauterine hypoxia, congenital and neonatal infections, and respiratory distress syndrome.

CPAP is the first-line respiratory support for preterm infants with spontaneous breathing and signs of distress. It maintains alveolar stability, reduces the work of breathing, and improves gas exchange. Common CPAP methods include Bubble CPAP and Ventilator CPAP. Bubble CPAP generates pressure via a water column, while Ventilator CPAP uses a mechanical ventilator to maintain constant pressure.

Both methods are considered effective and safe, but definitions of CPAP failure vary across studies. This study aims to compare failure rates between Bubble CPAP and Ventilator CPAP as initial respiratory support in preterm infants with respiratory distress.

Research question: Is bubble CPAP more effective than ventilator CPAP for treating respiratory distress in preterm infants?

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

  • Neonates less than 72 hours of age and born between 28 and 36 weeks and 6 days of gestation with respiratory distress (Downe’s score more than or equal to 3) will be included in the study.

排除标准

  • Babies with either of the following will be excluded:
  • Congenital diaphragmatic hernia
  • Severe external congenital anomalies
  • Cardiac defects
  • Any respiratory support given outside hospital apart from oxygen
  • Surgical cases.

结局指标

主要结局

To compare the CPAP success rate between Bubble CPAP and Ventilator CPAP as the initial mode of respiratory support for preterm babies with respiratory distress.

时间窗: 72 hours

次要结局

  • 1. To compare the change in SOPI between bubble CPAP and Ventilator CPAP as the initial mode of respiratory support for preterm babies with respiratory distress up to 72 hours after initiation of treatment.
  • 2. To compare the adverse outcomes between Bubble CPAP & Ventilator CPAP during the treatment period.(4-6 weeks)
  • 3. To compare the duration of respiratory support among babies treated with either bubble CPAP & ventilator CPAP for respiratory distress.(4-6 weeks)

研究者

发起方
Dr Devi Pilakkal Gangadharan
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Dr Devi Pilakkal Gangadharan

JSS Medical College,JSS Academyof Higher Education and Research

研究点 (1)

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