Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates — NOAH  

Hemodynamic Instability Clinical Trial

Official title: Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates - the NOAH Study

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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

1. For feasibility of non-invasive CO measurement (first 20 patients)

2. For reproducibility and correlation of this measurement and ECHOcardiography (first 40 echocardiographic examinations)

3. For prediction of therapy response.

4. For correlation with clinical definitions of hypotension/hypoperfusion

5. For prediction of later clinical problems/complications of prematurity and impaired hemodynamic status. ;

Related Conditions & MeSH terms

• Cardiac Function
• Circulatory Transition
• Hemodynamic Instability
• Hemorrhage
• Hypoperfusion
• Hypotension
• Hypotension and Shock
• Intraventricular Hemorrhage

• NCT number: NCT04538079
• Study type: Observational
• Source: University College Cork
• Status: Terminated
• Start date: November 9, 2019
• Completion date: May 31, 2021