NCT05961657

USCOM Parameters in Preterm Infants: Reference Ranges

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Fondazione IRCCS San Gerardo dei Tintori · Academic / Other
• Sex: All
• Age: 2 Days – 16 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Very Low Birth Weight Infant
• Very Preterm Maturity of Infant

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-06
• Primary completion: 2023-08-09
• Completion: 2023-09-01
• First posted: 2023-07-27
• Last updated: 2023-07-27

Locations

1 site across 1 country: Italy