Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 739
- 试验地点
- 1
- 主要终点
- Physiological Outcome
研究概览
简要总结
The objective of this common multicenter protocol is to test the hypothesis that algorithmic tools using clinical Neonatal Intensive Care Unit (NICU) cardiorespiratory monitoring data can detect ventilatory control instability and predict chronic and acute respiratory consequences of ventilatory control instability and autonomic dysregulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 1 Week（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonatal Intensive Care Unit patient on cardiorespiratory monitor which has been configured to collect data to store for this study
- •< 29 wks Gestational Age
- •< 1 wk Chronological
排除标准
- •Unlikely to survive or decision not to pursue full care
- •Major congenital or chromosomal anomaly
结局指标
主要结局
Physiological Outcome
时间窗: 36 weeks and 1 day to 37 weeks and 0 days, post-menstrual age
Reported Value will be the percentile value of scores, as plotted on a standard curve of scores for peers. The score is calculated by aggregating the following measurements: 1. Periodic Breathing Percentage (%) 2. Number of Apnea events (#) 3. Number of Bradycardia events (#) 4. Number of Desaturation events (#) 5. Number of combined events (example Apnea with Bradycardia and Desaturation (#)
Clinical Outcome
时间窗: 40 weeks post-menstrual age.
"Favorable": Either (1) an inpatient at 40 weeks post-menstrual age and not on oxygen, nor on other flow/pressure respiratory support, nor on inhaled/oral/IV respiratory medications, OR (2) discharged prior to 40 weeks post-menstrual age not on respiratory meds, oxygen, or other respiratory support. "Unfavorable": Either (1) Deceased at 40 weeks , (2) inpatient on meds/O2/support at 40 weeks post-menstrual age, or (3) previously discharged prior to 40 weeks on meds/O2/support
次要结局
- necrotizing enterocolitis(before 52 weeks post-menstrual age)
- pulmonary hypertension(before 52 weeks post-menstrual age)
- time on respiratory support and medications(before 52 weeks post-menstrual age)
- chronic lung disease(before 52 weeks post-menstrual age)
- sepsis(before 52 weeks post-menstrual age)
研究者
Joseph R Moorman
Professor of Medicine
University of Virginia