Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 5
- 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 the study is to demonstrate, in a routine clinical environment across a number of centers, that the fabian-PRICO can adequately maintain oxygen saturation, with minimal staff intervention.
详细描述
This is a randomized cross-over study. Subjects will be assigned to two, nominally 24-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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Respiratory insufficiency of infants in the neonatal unit who require respiratory support and supplemental oxygen in one of 4 the therapeutic categories (Intubated HFO, Intubated CMV, Non-Invasive nasal mask, nasal cannula).
- •<30 kg at study entry
- •Informed Consent Form obtained as per EC requirement
排除标准
- •Not expected to complete 48 hours of the current respiratory support therapeutic category
- •Congenital anomalies
- •Uncontrolled hemodynamics
- •Severe airflow obstruction
- •Intracranial hypertension
- •Start of caffeine therapy within 12 hours
- •Attending physician does not believe participation of the patient is in their best interest.
结局指标
主要结局
Target Range Compliance:
时间窗: 24 hours
Percent-Time with SpO2 a) \<80% and b) with \>98% SpO2 with FiO2\>21%
次要结局
- Avoidance of SpO2 Extremes:(24 hours)