Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates (NOAH)

U

University College Cork (UCC)

Status

Terminated

Conditions

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

Treatments

Device: Multimodal objective non-invasive Monitoring

Study type

Observational

Funder types

Other

Identifiers

NCT04538079
ED001/19UCC

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

56 patients

Sex

All

Ages

1 minute to 20 hours old

Volunteers

No Healthy Volunteers

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

Trial design

56 participants in 2 patient groups

Feasibility/Accuracy/Reproducibility
Description:
The first 20 participants will be analysed for feasibility and the first 40 ECHOs for accuracy/reproducibility of non-invasive Cardiac Output Monitoring with ECHO as reference Method.
Treatment:
Device: Multimodal objective non-invasive Monitoring
Prediction of Circulatory Failure
Description:
Together with the Feasibility/Accuracy/Reproducibility Cohort this group's results will be analysed for prediction of circulatory failure defined as an ultrasound abnormality (IVH grade 3 - 4) or death within the first two weeks of life.
Treatment:
Device: Multimodal objective non-invasive Monitoring

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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