Hemodynamic Evaluation in Preterm Babies Using UltraSonic Cardiac Output Monitor (USCOM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cardiac Output at 7 days
研究概览
简要总结
The goal of this observational study is to learn about the feasibility of hemodynamic measurement by the UltraSonic Cardiac Output Monitor (USCOM) in very preterm or very-low-birth-weight infants. The main questions it aims to answer are: 1) establishing reference ranges for USCOM parameters in this specific population, 2) assessing the effect of patients' characteristics and other possible confounders on USCOM parameters, and 3) evaluating the short-term repeatability of the measurement. Participants will receive USCOM measurements on 3, 7, and 14 postnatal days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Days 至 16 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age at birth below 32 weeks and/or
- •birth weight (BW) below 1500 g
排除标准
- •congenital heart diseases,
- •hemodynamic instability requiring drugs that affect hemodynamics (e.g., inotropes)
结局指标
主要结局
Cardiac Output at 7 days
时间窗: 7 ± 2 days of life
Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min
Systemic Vascular Resistance Index at 14 days
时间窗: 14 ± 2 days of life
Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d\*s\*cm-5/m2
Cardiac Output at 14 days
时间窗: 14 ± 2 days of life
Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min
Cardiac Index at 3 days
时间窗: 3 ± 1 days of life
Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2
Cardiac Index at 7 days
时间窗: 7 ± 2 days of life
Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2
Systemic Vascular Resistance Index at 3 days
时间窗: 3 ± 1 days of life
Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d\*s\*cm-5/m2
Cardiac Index at 14 days
时间窗: 14 ± 2 days of life
Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2
Systemic Vascular Resistance Index at 7 days
时间窗: 7 ± 2 days of life
Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d\*s\*cm-5/m2
Cardiac Output at 3 days
时间窗: 3 ± 1 days of life
Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min
次要结局
未报告次要终点
研究者
Daniela Doni
Consultant Neonatologist
Fondazione IRCCS San Gerardo dei Tintori