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临床试验/CTRI/2025/10/095995
CTRI/2025/10/095995尚未招募不适用

Comparison Of Bubble CPAP (Variable Flow CPAP) Vs Pressure Sources Of CPAP In Preterm Infants An Open Labelled Randomized Controlled Trial.

AIIMS Bhopal1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
AIIMS Bhopal
入组人数
100
试验地点
1
主要终点
1.CPAP failure in the first 72 hours of birth

研究概览

简要总结

Respiratory distress syndrome (RDS) is the most common pulmonary aliment in preterm newborns, and the incidence may reach up to 80 per cent in the extreme preterm populations (less than 28 weeks). With the antenatal corticosteroid in preterm pregnancy, early onset respiratory distress in preterm newborns is supported with continuous positive airway pressure support (CPAP) which has gained popularity due to its low cost, non- invasive respiratory support. Following the widespread adoption of these interventions over the past several decades, the principle from of respiratory support for preterm infants with or at risk of RDS has moved from mechanical ventilation via an endotracheal tube to non- invasive ventilation. However, given the level of certainty about the effect of bubble CPAP versus other pressure sources on the risk of treatment failure and most associated morbidity and mortality for preterm infants, further trials are needed to provide evidence of sufficient validity and practice. This trial aims at comparing the two common varieties of CPAP for their clinical outcomes as the primary mode of respiratory therapy.

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 (less than 37 completed weeks at birth) who develop early onset respiratory distress requiring CPAP within 6 hours of birth.

排除标准

  • Surgical anomalies of chest and abdomen
  • Syndromic newborns
  • Preterm infants who require delivery room intubation and early surfactant replacement therapy.
  • Perinatal asphyxia with encephalopathy or cord pH < 7
  • Pneumothorax or air-leaks prior to enrolment.

结局指标

主要结局

1.CPAP failure in the first 72 hours of birth

时间窗: baseline data, 1 day, 3 days. 7 days, 14 days and 28 days

2.Need of mechanical ventilation

时间窗: baseline data, 1 day, 3 days. 7 days, 14 days and 28 days

3.Incidence of hypoxic respiratory failure

时间窗: baseline data, 1 day, 3 days. 7 days, 14 days and 28 days

次要结局

  • 1.Duration of respiratory support.(2.Need for surfactant replacement therapy)

研究者

发起方
AIIMS Bhopal
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Cosmica Shah

AIIMS Bhopal

研究点 (1)

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