Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates - the NOAH Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Adverse Outcome of Circulatory Failure
研究概览
简要总结
Study type: Prospective Observational trial Study design: Longitudinal Population: Preterm newborns <32 weeks gestational age Hypothesis: The inclusion of non-invasive physiological measures of cardiac output, peripheral perfusion and brain oxygenation (NIRS) for preterm neonates is feasible and reveals additional information on the hemodynamic status compared to blood pressure alone. These measurements can improve the ability to rapidly identify those infants who might benefit from intervention and are correlated with short term clinical outcomes.
详细描述
Understanding neonatal hemodynamics is key to neonatal care. Despite decades of research, uncertainty continues as to how best assess impaired hemodynamics.
Hypotension defined by a low Mean Arterial Blood Pressure (MABP) remains a common issue in preterm infants, affecting up to 30% of extremely preterm infants.
It is common to focus only on MABP thus neglecting the complex and dynamic (patho)physiology that may be present in newborn infants. Providing sufficient cellular oxygenation is the primary task of the circulatory system and different factors may compromise it. In this prospective observational study the investigators will examine various forms of objective non-invasive continuous hemodynamic monitoring methods in very preterm infants
- For feasibility of non-invasive CO measurement (first 20 patients)
- For reproducibility and correlation of this measurement and ECHOcardiography (first 40 echocardiographic examinations)
- For prediction of therapy response.
- For correlation with clinical definitions of hypotension/hypoperfusion
- For prediction of later clinical problems/complications of prematurity and impaired hemodynamic status.
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 Minute 至 20 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates of 23 weeks 0 days to 31 weeks 6 days
- •NIRS/non-invasive Cardiac Output - device available
- •Parental Informed Consent
排除标准
- •Congenital anomalies
- •Major cardiac defects
- •Parents decline to consent to the study
结局指标
主要结局
Adverse Outcome of Circulatory Failure
时间窗: 14 days
Correlation of clinical, laboratory, conventional and multimodal non-invasive monitoring and/or a combination of variables with ultrasound abnormality (IVH grade 3 - 4/any IVH) or death within the first two weeks of life.
次要结局
- Reproducibility of left ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring(48 hours)
- Reproducibility of absolute superior vena cava flow estimated by non-invasive Cardiac Output Monitoring compared to estimation by echocardiography(48 hours)
- Reproducibility of superior vena cava flow indexed to bodyweight estimated by non-invasive Cardiac Output Monitoring compared to estimation by echocardiography(48 hours)
- Prediction of response to volume/red-blood cell transfusion by Corrected Flow Time estimated with non-invasive Cardiac Output Monitoring(48 hours)
- Feasibility of non-invasive Cardiac Output Monitoring and Pulsatility Index(48 hours)
- Reproducibility of absolute right ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring(48 hours)
- Reproducibility of left ventricular systolic time interval ratio estimated by non-invasive Cardiac Output Monitoring compared to echocardiography(48 hours)
- Reproducibility of absolute left ventricular cardiac output estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring(48 hours)
- Reproducibility of right ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to estimation by non-invasive Cardiac Output Monitoring(48 hours)
- Reproducibility of left ventricular stroke volume estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring(48 hours)
- Correlation of non-invasive Cardiac Output Monitoring with echocardiography(48 hours)
- Prediction of response to volume/red-blood cell transfusion by St roke Volume Variation estimated with non-invasive Cardiac Output Monitoring(48 hours)
- Prediction of Prediction of response to inotropes by non-invasive Cardiac Output Monitoring response to therapy by non-invasive Cardiac Output Monitoring(48 hours)
- Correlation with definitions of hypotension(48 hours)
研究者
Dr. Gene Dempsey
Professor
University College Cork