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Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates

NCT04538079 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2023-01-27

No results posted yet for this study

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • University College Cork

    lead OTHER

Principal Investigators

  • Eugene M Dempsey, MD · UCC

Eligibility

Min Age
1 Minute
Max Age
20 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-09
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04538079 on ClinicalTrials.gov