Hemodynamic Evaluation in Preterm Babies Using UltraSonic Cardiac Output Monitor (USCOM)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Very Low Birth Weight Infant
- Sponsor
- Fondazione IRCCS San Gerardo dei Tintori
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Cardiac Output at 7 days
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Daniela Doni
Consultant Neonatologist
Fondazione IRCCS San Gerardo dei Tintori
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Cardiac Output at 7 days
Time Frame: 7 ± 2 days of life
Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min
Systemic Vascular Resistance Index at 14 days
Time Frame: 14 ± 2 days of life
Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d\*s\*cm-5/m2
Cardiac Output at 14 days
Time Frame: 14 ± 2 days of life
Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min
Cardiac Index at 3 days
Time Frame: 3 ± 1 days of life
Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2
Cardiac Index at 7 days
Time Frame: 7 ± 2 days of life
Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2
Systemic Vascular Resistance Index at 3 days
Time Frame: 3 ± 1 days of life
Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d\*s\*cm-5/m2
Cardiac Index at 14 days
Time Frame: 14 ± 2 days of life
Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2
Systemic Vascular Resistance Index at 7 days
Time Frame: 7 ± 2 days of life
Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d\*s\*cm-5/m2
Cardiac Output at 3 days
Time Frame: 3 ± 1 days of life
Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min