USCOM Parameters in Preterm Infants: Reference Ranges

Study Overview
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Brief Summary
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The goal of this observational study is to learn about the feasibility of hemodynamic measurement by the UltraSonic Cardiac Output Monitor (USCOM) in very preterm or very-low-birth-weight infants. The main questions it aims to answer are: 1) establishing reference ranges for USCOM parameters in this specific population, 2) assessing the effect of patients' characteristics and other possible confounders on USCOM parameters, and 3) evaluating the short-term repeatability of the measurement. Participants will receive USCOM measurements on 3, 7, and 14 postnatal days.

Official Title
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Hemodynamic Evaluation in Preterm Babies Using UltraSonic Cardiac Output Monitor (USCOM)

Conditions
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Very Low Birth Weight Infant, Very Preterm Maturity of Infant

Intervention / Treatment
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* Diagnostic Test: Hemodynamic measurements by USCOM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gestational age at birth below 32 weeks and/or birth weight (BW) below 1500 g Exclusion Criteria: congenital heart diseases, hemodynamic instability requiring drugs that affect hemodynamics (e.g., inotropes)

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 16 Days

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Hemodynamic measurements by USCOM|We will measure cardiac output, cardiac index, and systemic vascular resistance index on 3, 7, and 14 postnatal days using the UltraSonic Cardiac Output Monitor.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Output at 3 days | Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min | 3 ± 1 days of life | 
| Cardiac Output at 7 days | Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min | 7 ± 2 days of life | 
| Cardiac Output at 14 days | Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min | 14 ± 2 days of life | 
| Cardiac Index at 3 days | Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2 | 3 ± 1 days of life | 
| Cardiac Index at 7 days | Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2 | 7 ± 2 days of life | 
| Cardiac Index at 14 days | Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2 | 14 ± 2 days of life | 
| Systemic Vascular Resistance Index at 3 days | Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d*s*cm-5/m2 | 3 ± 1 days of life | 
| Systemic Vascular Resistance Index at 7 days | Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d*s*cm-5/m2 | 7 ± 2 days of life | 
| Systemic Vascular Resistance Index at 14 days | Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d*s*cm-5/m2 | 14 ± 2 days of life |