Impact of Heart Rate Characteristics Monitoring in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,003
- 试验地点
- 16
- 主要终点
- Number of Ventilator-free Days
研究概览
简要总结
Hypothesis: Fewer neonates managed using information from heart rate characteristics (HRC) will require intubation and mechanical ventilation as a result of sepsis and sepsis-like illness.
Infants will be randomly assigned to one of two groups. One group of infants will have the HRC index known to the physicians caring for them, and physicians will use the HRC index as they desire to aid in clinical management.
Infants in the other group will have the HRC index recorded, but this information will not be displayed to the physicians caring for the infants.
详细描述
Following randomization, infants will be managed as usual practice. The treating physicians of the HRC-display group will be able to utilize the HRC score to assist in the care of the infant. The physicians of the no-display group will provide care as per standard.
Clinical symptoms will be treated according to the medical discretion of each physician. Cultures will be obtained and antibiotics administered as per the medical discretion of the physicians.
Clinical, culture results, antibiotic administration, ventilator use, and outcome at 120 days data will be collected on the infants as well as their HRC score calculated by the HeRO heart rate characteristics monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants admitted to NICU
- •Birth weight < 1500 grams
- •Gestational age < or = 32 weeks
- •Informed consent obtained from parent
排除标准
- •Evidence of sustained cardiac arrhythmia
- •Use of an electronic pacemaker
结局指标
主要结局
Number of Ventilator-free Days
时间窗: 120 days
次要结局
- Duration of Hospital Stay(120 days)
- Mortality(120 days)
- Days on Antibiotics(120 days)