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临床试验/NCT02003846
NCT02003846已完成不适用

Comparing the Effects of Bubble Nasal CPAP Versus Ventilator Nasal CPAP in Preterm Infants

Maimonides Medical Center1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Physiologic parameters

研究概览

简要总结

There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal intensive care units (NICU) use an underwater bubbling system and others use a ventilator to generate the pressure. There is no right or wrong way to generate the pressure and both methods are approved and accepted.

The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on each for a defined time period and reviewing the infant's vital signs. The investigators expect that the pressure generated by bubble CPAP will be better and lead to improved vital signs.

详细描述

There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal intensive care units (NICU) use an underwater bubbling system and others use a ventilator to generate the pressure. There is no right or wrong way to generate the pressure and both methods are approved and accepted.

The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on each for a defined time period and reviewing the infant's vital signs. The investigators expect that the pressure generated by bubble CPAP will be better and lead to improved vital signs.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
2 Days 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates between 26-32 weeks gestational age who have been on Nasal CPAP for at least 48hrs on fraction of inspired oxygen (FiO2) of < or = 0.
  • Parental consent will be obtained prior to enrollment.

排除标准

  • Infants with severe congenital anomalies, such as airway or chest wall deformities, pulmonary hypoplasia, congenital heart disease, neurologic abnormalities including severe intraventricular hemorrhage (IVH) and need for surgery eg. for necrotizing enterocolitis will be excluded from the study. Any infants with genetic/chromosomal abnormalities will be excluded.

结局指标

主要结局

Physiologic parameters

时间窗: 2 hours

heart rate, respiratory rate, oxygen saturation

次要结局

  • Physiologic parameters(2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shantanu Rastogi

Attending Neonatologist

Maimonides Medical Center

研究点 (1)

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