Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemodynamic measurements by USCOM | Diagnostic Test | 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. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
We include very preterm and/or very low birth weight infants without heart disease as assessed by echocardiography, who are considered hemodynamically stable by the attending physician and do not require drugs that might affect the cardiocirculatory function (e.g., inotropes).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela Doni, MD | Contact | +39039233 | 9173 | danieladoni9@gmail.com |
| Emanuela Zannin, PhD | Contact | emanuela.zannin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Daniela Doni, MD | Fondazione IRCCS San Gerardo dei Tintori | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS San Gerardo dei Tintori | Recruiting | Monza | Monza E Brianza | 20900 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32758264 | Background | Doni D, Nucera S, Rigotti C, Arosio E, Cavalleri V, Ronconi M, Ventura ML, Fedeli T. Evaluation of hemodynamics in healthy term neonates using ultrasonic cardiac output monitor. Ital J Pediatr. 2020 Aug 5;46(1):112. doi: 10.1186/s13052-020-00872-x. | |
| 20605971 | Background | Patel N, Dodsworth M, Mills JF. Cardiac output measurement in newborn infants using the ultrasonic cardiac output monitor: an assessment of agreement with conventional echocardiography, repeatability and new user experience. Arch Dis Child Fetal Neonatal Ed. 2011 May;96(3):F206-11. doi: 10.1136/adc.2009.170704. Epub 2010 Jul 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 31326967 | Background | Fraga MV, Dysart KC, Rintoul N, Chaudhary AS, Ratcliffe SJ, Fedec A, Kren S, Cohen MS, Kirpalani H. Cardiac Output Measurement Using the Ultrasonic Cardiac Output Monitor: A Validation Study in Newborn Infants. Neonatology. 2019;116(3):260-268. doi: 10.1159/000501005. Epub 2019 Jul 19. |
| 21933558 | Background | He SR, Zhang C, Liu YM, Sun YX, Zhuang J, Chen JM, Madigan VM, Smith BE, Sun X. Accuracy of the ultrasonic cardiac output monitor in healthy term neonates during postnatal circulatory adaptation. Chin Med J (Engl). 2011 Aug;124(15):2284-9. |