NCT04538079

Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: University College Cork · Academic / Other
• Sex: All
• Age: 1 Minute – 20 Hours
• Healthy volunteers: —

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Multimodal objective non-invasive Monitoring	Multimodal objective non-invasive monitoring including cerebral oxygenation (NIRS), pulse oximetry with Pulsatility Index (PI) and non-invasive Cardiac Output Monitoring will be recorded but not used for clinical decision making. 2 ECHOs will be performed (one within the first 24h, one in the 2nd 24 hours after birth)

Timeline

• Start date: 2019-11-09
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2020-09-03
• Last updated: 2023-01-27

Locations

1 site across 1 country: Ireland