A Randomized, Multicenter Study of the Safety and Performance of Fabian PRICO for Saturation Targeting With Non-invasive Respiratory Support
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Target Range Compliance
研究概览
简要总结
This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product. The purpose of this study is to assess, in a routine clinical environment at two centers the use of fabian-PRICO with noninvasive ventilation and its safety and performance at targeting and maintaining accurate SpO2 levels.
详细描述
This is a randomized cross-over study. Subjects will be assigned to two, nominally 12-hour interventions, one with standard manual titration of FiO2 and the other with automated adjustment (PRICO). The order of these two interventions will be random.
In addition to the ventilators data, basic demographics (i.e., gestational age, birth weight, age, weight at study) of the participating infants will be recorded in the eCRF.
This study has no additional follow-up visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants in the neonatal unit that require non-invasive respiratory support and supplemental oxygen provided by fabian Therapy evolution ventilator
- •<37 + 0 weeks gestation
- •<10 kg at study entry
- •FiO2 > 0.25
- •Informed consent form obtained as per EC requirements
排除标准
- •Not expected to complete 24 hours of non-invasive respiratory support
- •Congenital anomalies
- •Uncontrolled hemodynamics
- •Severe airflow obstruction
- •Intracranial hypertension
- •Start of caffeine therapy within 12 hours
- •Attending physician does not believe participation in the study is in the patient's best interest
结局指标
主要结局
Target Range Compliance
时间窗: 12 hours
Percentage of time that SpO2 is between 90-95% or above 95% when FiO2 = 21%
次要结局
- Avoidance of SpO2 Extremes(12 hours)