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
- 2
- 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.
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