Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study

Study Overview
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Brief Summary
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This is an observational study in newborn term and preterm infants. The study will validate if non-invasive continuous cardiac output monitoring is feasible in newborn infants, if normative values can be constructed and what is the effect of fluid boluses and inotropes on cardiac output and peripheral vascular resistance.

Detailed Description
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This is a 3-year prospective observational study. Principal research question: Is non-invasive continuous cardiac output (CO) measurement a validated tool of comprehensive cardiovascular assessment in neonatal intensive care (NICU)? Secondary research questions: Can robust normal ranges of CO be constructed for neonates undergoing cardiovascular measurement? How do neonatal interventions (fluid boluses, ventilation and inotropes) affect CO? Does the Non-invasive continuous cardiac output monitoring in children with foetal growth restriction (FGR) differ from normative CO data as above (1)? A prospective study of stable newborn babies in the postnatal ward and sick term and preterm infants in the NICU in 36 months.

Official Title
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Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study

Conditions
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Cardiac Output, Low, Cardiac Output, High, Blood Pressure

Intervention / Treatment
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* Device: NICAS cardiac output monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy term infants in postnatal ward (within the first 72 hours of age) Term and Preterm infants (including those with FGR) admitted to the neonatal unit Written informed parental consent (prospective for postnatal ward and retrospective for babies admitted to the neonatal units) Exclusion Criteria: Antenatal or postnatal diagnosis of severe congenital anomaly Infants with no realistic chance of survival Infants who are >12 hours of age Infants with fragile skin not permitting skin probe placement

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 40 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Babies (24-42 weeks)<br>All babies born between 24 and 42 weeks | Device: NICAS cardiac output monitor<br>* Non-invasive continuous cardiac output monitoring device using total body bioimpedance.<br>|
| Preterm infants<br>Preterm infants with fetal growth restriction | Device: NICAS cardiac output monitor<br>* Non-invasive continuous cardiac output monitoring device using total body bioimpedance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemodynamic outcome comparison to echocardiography measured CO | Non-invasive continuous Cardiac Output (CO) measurement (mls/kg/min) during the first month of life in comparison to echocardiography measured CO (mls/kg/min) | 36 months | 
| Changes in cardiac output | Changes in cardiac output (CO) measurement (mls/kg/min) in relation to neonatal intervention | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in clinical outcome - Survival at discharge | Survival at discharge | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Pressure