Novel Low Cost Bubble CPAP as an Alternative Non-invasive Respiratory Support Among Preterm Infants With Respiratory Distress Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas
研究概览
简要总结
This is a single-blind randomized controlled trial done in a Level III neonatal intensive care unit. Preterm newborns with RDS were randomized to receive oxygen therapy through bubble CPAP vs ventilator-derived CPAP. Differences in arterial blood gases, oxygen saturation, number of surfactant and CPAP failure rate between study groups were analyzed.
详细描述
Background and Objective: Respiratory distress syndrome (RDS) among premature infants is one of the major causes of neonatal death. The use of continuous positive airway pressure (CPAP) has become a standard of care for preterm newborns with RDS. In countries faced with the challenge of improving neonatal care, cost-effective innovations for respiratory support are a promising intervention. This study determined the efficacy of a low-cost bubble CPAP as an alternative non-invasive oxygen therapy for newborn infants with RDS.
METHODS: This is a single-blind randomized controlled trial done in a Level III neonatal intensive care unit. Preterm newborns with RDS were randomized to receive oxygen therapy through bubble CPAP vs ventilator-derived CPAP. Differences in arterial blood gases, oxygen saturation, number of surfactant and CPAP failure rate between study groups were analyzed.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The study Blinded the investigator and outcome assesors
入排标准
- 年龄范围
- 5 Minutes 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Included are preterm neonates less than 36 weeks (WHO definition)
- •admitted at NICU
- •APGAR scores of > 7 in the 1st and 5th minute of life
- •in respiratory distress at birth,
- •radiologic findings of RDS
- •Respiratory Severity Score (RSS) or Downe's score > 4 at 10-15 minutes after hooking to CPAP
- •requiring CPAP or more than 40% FiO2
排除标准
- •Infants requiring neonatal resuscitation such as bag mask ventilation, chest compression or intubation at birth
- •with comorbidities such as facial anomalies, tracheoesophageal fistulas, congenital heart disease, and other congenital anomalies which may interfere with the interface of both devices.
研究组 & 干预措施
Vayu CPAP Group
The patients will be hooked to VAYu bCPAP
干预措施: Vayu bCPAP (Device)
Mechanical Ventilator Driven CPAP
Patients will be hooked to Mechanical Ventilator Driven CPAP
干预措施: Mechanical Ventilator Driven CPAP (Device)
结局指标
主要结局
Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas
时间窗: 8 months
Difference in the Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas
Oxygen Saturation
时间窗: 8 months
Difference in the oxygen saturation using pulse oximeter
Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas
时间窗: 8 months
Difference in the Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas
次要结局
- CPAP Failure(8 months)
- surfactant use(8 months)
研究者
Navid Roodaki
Dr.
Ilocos Training and Regional Medical Center