Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates

NCT ID: NCT04538079

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-09
• Study Completion Date: 2021-05-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Multimodal objective non-invasive Monitoring

Intervention Type: 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)

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.

Multimodal objective non-invasive Monitoring

Intervention Type: 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)

Interventions

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)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 20 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College Cork

OTHER

Sponsor Role: lead

Responsible Party

Dr. Gene Dempsey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eugene M Dempsey, MD

Role: PRINCIPAL_INVESTIGATOR

UCC

Locations

Neonatal Unit Cork University Maternity Hospital

Cork, , Ireland

Countries

Ireland

Other Identifiers

ED001/19UCC

Identifier Type: -

Identifier Source: org_study_id