跳至主要内容
临床试验/NCT07162285
NCT07162285Enrolling By Invitation不适用

Efficacy of Delivery Room Bubble Continuous Positive Airway Pressure in Preterm Neonates <34 Weeks Having Respiratory Distress

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
52
试验地点
2
主要终点
Need for mechanical ventilation

研究概览

简要总结

Background

When babies are born too early (preterm), their lungs are often not fully developed. They may have trouble breathing because their airways and chest are not strong enough, and their lungs don't make enough surfactant (a natural substance that keeps the lungs open). This makes their tiny lungs collapse easily, causing breathing problems.

Continuous Positive Airway Pressure (CPAP) is a safe and gentle way to help these babies breathe. CPAP works by sending a steady flow of air into the baby's nose, which keeps the lungs open and helps the baby breathe without needing a breathing machine (ventilator). The earlier CPAP is started after birth, the better it may help babies breathe more easily and reduce serious lung problems.

Purpose of the Study

This study will look at whether giving bubble CPAP to preterm babies immediately in the delivery room (within the first 10 minutes after birth) can lower the risk of breathing problems and death during their hospital stay.

How the Study Will Be Done

The research will take place at Bangabandhu Sheikh Mujib Medical University (BSMMU) in Dhaka.

Babies born before 34 weeks of pregnancy who meet the study criteria will be included, with their parents' consent.

Babies will be randomly divided into two groups:

CPAP group - babies will be given bubble CPAP soon after birth in the delivery room.

Control group - babies will receive only oxygen support in the delivery room.

Both groups will then be moved to the Neonatal Intensive Care Unit (NICU) for further treatment as per hospital guidelines.

The results will be compared to see which group had better outcomes.

Expected Outcome

We expect that starting bubble CPAP very early will help preterm babies breathe better, reduce the need for ventilators, and lower the risk of long-term breathing problems or death.

详细描述

Preterm birth remains one of the most significant contributors to neonatal morbidity and mortality worldwide. Globally, an estimated 15 million infants are born prematurely each year, with the majority occurring in low- and middle-income countries (Blencowe et al., 2013; WHO, 2018). Complications related to prematurity account for over one million deaths annually, and in Bangladesh, prematurity is responsible for nearly one-third of neonatal deaths. Effective respiratory support strategies are therefore critical in improving outcomes in this population.

Continuous Positive Airway Pressure (CPAP) is a well-established mode of non-invasive respiratory support that has been shown to reduce ventilator dependence and the risk of chronic lung disease in preterm infants with respiratory distress. By providing a continuous distending pressure, CPAP stabilizes the alveoli, reduces atelectasis, conserves endogenous surfactant, improves lung compliance, and decreases the work of breathing. These physiological benefits reduce the need for intubation, mechanical ventilation, and exogenous surfactant therapy, all of which are associated with short- and long-term complications.

Bubble CPAP (bCPAP) represents a simple, low-cost, and effective CPAP system particularly suitable for use in resource-limited settings. The system can be assembled using readily available components, and healthcare workers can be trained in its use with relative ease. Compared to ventilator-driven CPAP, bCPAP requires less technical infrastructure and is associated with a lower risk of complications. Previous studies have demonstrated that early initiation of bCPAP is associated with reduced need for intubation and surfactant therapy, shorter duration of respiratory support, and improved weight gain, without increasing adverse outcomes such as pneumothorax (Narendran et al., 2013; Bahareh et al., 2013).

There is increasing evidence that the timing of CPAP initiation plays an important role in determining outcomes. Early initiation of CPAP in the delivery room, before the onset of severe atelectasis, appears more effective than delayed initiation. A systematic review and meta-analysis comparing early versus late CPAP demonstrated that early initiation significantly reduced subsequent use of mechanical ventilation (RR 0.55; 95% CI 0.32-0.96), though effects on mortality, bronchopulmonary dysplasia (BPD), and pneumothorax were not significant (Gupta et al., 2015).

Despite this evidence, there is limited research evaluating the efficacy of immediate delivery room initiation of bCPAP in low-resource countries such as Bangladesh, where the burden of prematurity is high and access to advanced ventilatory support is limited. This randomized controlled trial aims to address this gap.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Minutes 至 30 Minutes(Child)
性别
All
接受健康志愿者

入选标准

  • Neonate gestational age less than 34 weeks delivered at BSMMU. Having respiratory distress.

排除标准

  • Congenital anomaly such as cleft lip, cleft palate, congenital diaphragmatic hernia.
  • Newborn required delivery room intubation

结局指标

主要结局

Need for mechanical ventilation

时间窗: From birth until 7 completed days of life

This outcome will allow assessment of whether delivery room bubble CPAP reduces respiratory complications with standard supplemental oxygen.

Requirement for surfactant therapy

时间窗: From birth until 7 completed days of life

This outcome will allow assessment of whether delivery room bubble CPAP reduces need for surfcatant with standard supplemental oxygen.

Death within the early neonatal period

时间窗: From birth until 7 completed days of life

This outcome will allow assessment of whether delivery room bubble CPAP reduces early mortality compared with standard supplemental oxygen.

次要结局

未报告次要终点

研究者

发起方
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nuzhat Nuary Jui

Resident Doctor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (2)

Loading locations...

相似试验