Very Low Birth Weight Infant, Very Preterm Maturity of Infant
Conditions
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.
Interventions
DIAGNOSTIC_TESTHemodynamic 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.
Sponsors
Fondazione IRCCS San Gerardo dei Tintori
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Days to 16 Days
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Output at 3 days | 3 ± 1 days of life | Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min |
| Cardiac Output at 7 days | 7 ± 2 days of life | Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min |
| Cardiac Output at 14 days | 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 | 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 | 7 ± 2 days of life | Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2 |
| Cardiac Index at 14 days | 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 3 days | 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 |
| Systemic Vascular Resistance Index at 7 days | 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 |
| Systemic Vascular Resistance Index at 14 days | 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 |
Countries
Italy
Contacts
Primary ContactDaniela Doni, MD
Backup ContactEmanuela Zannin, PhD
Outcome results
None listed