Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Changes in cardiac output
研究概览
简要总结
This is an observational study in newborn term and preterm infants. The study will validate if non-invasive continuous cardiac output monitoring is feasible in newborn infants, if normative values can be constructed and what is the effect of fluid boluses and inotropes on cardiac output and peripheral vascular resistance.
详细描述
This is a 3-year prospective observational study.
Principal research question:
Is non-invasive continuous cardiac output (CO) measurement a validated tool of comprehensive cardiovascular assessment in neonatal intensive care (NICU)?
Secondary research questions:
- Can robust normal ranges of CO be constructed for neonates undergoing cardiovascular measurement?
- How do neonatal interventions (fluid boluses, ventilation and inotropes) affect CO?
- Does the Non-invasive continuous cardiac output monitoring in children with foetal growth restriction (FGR) differ from normative CO data as above (1)?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Hour 至 40 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy term infants in postnatal ward (within the first 72 hours of age)
- •Term and Preterm infants (including those with FGR) admitted to the neonatal unit
- •Written informed parental consent (prospective for postnatal ward and retrospective for babies admitted to the neonatal units)
排除标准
- •Antenatal or postnatal diagnosis of severe congenital anomaly
- •Infants with no realistic chance of survival
- •Infants who are >12 hours of age
- •Infants with fragile skin not permitting skin probe placement
结局指标
主要结局
Changes in cardiac output
时间窗: 36 months
Changes in cardiac output (CO) measurement (mls/kg/min) in relation to neonatal intervention
Haemodynamic outcome comparison to echocardiography measured CO
时间窗: 36 months
Non-invasive continuous Cardiac Output (CO) measurement (mls/kg/min) during the first month of life in comparison to echocardiography measured CO (mls/kg/min)
次要结局
- Changes in clinical outcome - Survival at discharge(36 months)