Clinical trial NCT04538079: Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates
Official title: Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates - the NOAH Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypotension and Shock
Hypoperfusion
Hemodynamic Instability
Intraventricular Hemorrhage
Cardiac Function
Circulatory Transition
Keywords: objective hemodynamic multimodal Monitoring
premature preterm infant
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 56
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm Neonates born at a gestational age of 23 weeks 0 days to 31 weeks 6 days.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Neonates of 23 weeks 0 days to 31 weeks 6 days
* NIRS/non-invasive Cardiac Output - device available
* Parental Informed Consent

Exclusion Criteria:

* Congenital anomalies
* Major cardiac defects
* Hydrops
* Parents decline to consent to the study

Primary outcomes:
measure: Adverse Outcome of Circulatory Failure
timeFrame: 14 days
Secondary outcomes:
measure: Feasibility of non-invasive Cardiac Output Monitoring and Pulsatility Index
timeFrame: 48 hours
measure: Reproducibility of absolute left ventricular cardiac output estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring
timeFrame: 48 hours
measure: Reproducibility of left ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring
timeFrame: 48 hours
measure: Reproducibility of left ventricular stroke volume estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring
timeFrame: 48 hours
measure: Reproducibility of absolute right ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring
timeFrame: 48 hours
measure: Reproducibility of right ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to estimation by non-invasive Cardiac Output Monitoring
timeFrame: 48 hours
measure: Reproducibility of left ventricular systolic time interval ratio estimated by non-invasive Cardiac Output Monitoring compared to echocardiography
timeFrame: 48 hours
measure: Reproducibility of absolute superior vena cava flow estimated by non-invasive Cardiac Output Monitoring compared to estimation by echocardiography
timeFrame: 48 hours
measure: Reproducibility of superior vena cava flow indexed to bodyweight estimated by non-invasive Cardiac Output Monitoring compared to estimation by echocardiography
timeFrame: 48 hours
measure: Correlation of non-invasive Cardiac Output Monitoring with echocardiography
timeFrame: 48 hours
measure: Prediction of response to volume/red-blood cell transfusion by Corrected Flow Time estimated with non-invasive Cardiac Output Monitoring
timeFrame: 48 hours
measure: Prediction of response to volume/red-blood cell transfusion by St roke Volume Variation estimated with non-invasive Cardiac Output Monitoring
timeFrame: 48 hours
measure: Prediction of Prediction of response to inotropes by non-invasive Cardiac Output Monitoring response to therapy by non-invasive Cardiac Output Monitoring
timeFrame: 48 hours
measure: Correlation with definitions of hypotension
timeFrame: 48 hours
Other outcomes:
measure: Burden of clinical suspicion indicating Circulatory Insufficiency
timeFrame: 48 hours
measure: Burden of Laboratory parameters indicating Circulatory Insufficiency
timeFrame: 48 hours
measure: Burden and Onset of Hypotension indicating Circulatory Insufficiency
timeFrame: 48 hours
measure: Burden of Cerebral Oxygenation indicating Circulatory Insufficiency
timeFrame: 48 hours
measure: Burden of Low Cardiac Output indicating Circulatory Insufficiency
timeFrame: 48 hours
measure: Burden of impaired cerebral Autoregulation
timeFrame: 48 hours
Locations:
city: Cork
country: Ireland
facility: Neonatal Unit Cork University Maternity Hospital
Study officials:
affiliation: UCC
name: Eugene M Dempsey, MD
role: PRINCIPAL_INVESTIGATOR
References: