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临床试验/NCT03711565
NCT03711565撤回不适用

Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support

University of California, Davis2 个研究点 分布在 1 个国家开始时间: 2016年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Respiratory Index Score (RSI)

研究概览

简要总结

Controlled randomized trial looking at Standard nasal continuous airway pressure (CPAP) respiratory support versus High Frequency CPAP in neonates who require respiratory support or who are being extubated and require support post extubation. Patients will be evaluated for need to be reintubated and oxygen requirement and PaCO2 levels

详细描述

This study is a randomized controlled trial comparing High Frequency nasal CPAP versus standard nasal CPAP. The patient population includes preterm newborns who require respiratory support but do not need to be initially intubated and preterm or term infants who are being extubated and will require support for the continued lung disease. After obtaining parental consent the patient will be randomized to one of the two treatments. Patients will be followed for requirement of level of oxygen and blood gases looking at acidity (pH) and PaCO2 and Bicarbonate(HCO3). A respiratory index score will be measured. Attending physician will determine the need for the patient to be intubated or reintubated depending on the patient selected. Additionally, frequency, duration and severity of Apnea, Bradycardia and Desaturation events will be recorded. Also safety issues to include pulmonary airleak, nasal injury, facial edema and scalp edema due to straps holding the device in place will be recorded. Also gaseous distension of the stomach and intestines will be assessed and compared between treatment arms. This study is not powered to look at long term outcomes.

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
— 至 4 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Newborn (0-28 days of age) admitted to Neonatal Intensive care unit (NICU)
  • Ordered Respiratory treatment of Nasal Continuous Airway Pressure (NCPAP) respiratory support

排除标准

  • Major congenital defect
  • Known or suspected chromosomal disorder

结局指标

主要结局

Respiratory Index Score (RSI)

时间窗: 72 hours after initiation of support

The scale is scored based on Fio2 (0 = \<30%, 1 = 30-39%, 2 = 40-49%, 3 = \> or equal to 50%), CPAP/Paw (0 = \<6, 1 = 6-7, 2 = 7-8, 3 = \>8), Spontaneous Respiratory Rate(RR) (0 = \<40, 1 = 40-59, 2 = 60-79, 3 = \> or equal to 80), Retractions (0 = none, 1 = mild, 2 = moderate, 3 = severe), and Apnea (0 = none, 1 = 1/2/2015, 2 = 3/4/2015, 3 = \>4). Average index scores will be compared between conditions.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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