Comparing Bubble and Ventilator Nasal CPAP in Preterm Infants
Comparing the Effects of Bubble Nasal CPAP Versus Ventilator Nasal CPAP in Preterm Infants
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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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New York
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Brooklyn、New York、美国、11219
- Maimonides Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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 = 0.3. Parental consent will be obtained prior to enrollment.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Premature infant
Each premature infant will be on bubble nasal CPAP for 2 hours and on ventilator nasal CPAP for 2 hours
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Physiologic parameters
大体时间：2 hours
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heart rate, respiratory rate, oxygen saturation
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2 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Physiologic parameters
大体时间：2 hours
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cerebral oxygen tissue extraction
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2 hours
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合作者和调查者
调查人员
- 首席研究员：Shantanu Rastogi, MD、Maimonides Medical Center
出版物和有用的链接
一般刊物
- Gregory GA, Kitterman JA, Phibbs RH, Tooley WH, Hamilton WK. Treatment of the idiopathic respiratory-distress syndrome with continuous positive airway pressure. N Engl J Med. 1971 Jun 17;284(24):1333-40. doi: 10.1056/NEJM197106172842401. No abstract available.
- Lee KS, Dunn MS, Fenwick M, Shennan AT. A comparison of underwater bubble continuous positive airway pressure with ventilator-derived continuous positive airway pressure in premature neonates ready for extubation. Biol Neonate. 1998;73(2):69-75. doi: 10.1159/000013962.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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