Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates

NCT04538079 | Terminated

• 1 other identifier: ED001/19UCC
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

objective hemodynamic multimodal Monitoring; premature preterm infant

Outcome Measures

Primary Outcomes (1)

• Adverse Outcome of Circulatory Failure

  Correlation of clinical, laboratory, conventional and multimodal non-invasive monitoring and/or a combination of variables with ultrasound abnormality (IVH grade 3 - 4/any IVH) or death within the first two weeks of life.

  14 days

Secondary Outcomes (14)

• Feasibility of non-invasive Cardiac Output Monitoring and Pulsatility Index

  48 hours

• Reproducibility of absolute left ventricular cardiac output estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring

  48 hours

• Reproducibility of left ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring

  48 hours

• Reproducibility of left ventricular stroke volume estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring

  48 hours

• Reproducibility of absolute right ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring

  48 hours

Other Outcomes (6)

• Burden of clinical suspicion indicating Circulatory Insufficiency

  48 hours

• Burden of Laboratory parameters indicating Circulatory Insufficiency

  48 hours

• Burden and Onset of Hypotension indicating Circulatory Insufficiency

  48 hours

Study Arms (2)

Feasibility/Accuracy/Reproducibility

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.

Device: Multimodal objective non-invasive Monitoring

Prediction of Circulatory Failure

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.

Device: Multimodal objective non-invasive Monitoring

Interventions

Multimodal objective non-invasive Monitoring DEVICE

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)

Feasibility/Accuracy/Reproducibility; Prediction of Circulatory Failure

Eligibility Criteria

• Age: 1 Minute - 20 Hours
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm Neonates born at a gestational age of 23 weeks 0 days to 31 weeks 6 days.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

Neonatal Unit Cork University Maternity Hospital

Cork, Ireland

Location

MeSH Terms

Conditions

Hypotension; Shock

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eugene M Dempsey, MD

  UCC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: September 3, 2020
• Study Start: November 9, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)