USCOM Parameters in Preterm Infants: Reference Ranges

Recruiting

• Conditions: Very Low Birth Weight Infant; Very Preterm Maturity of Infant

• Registration Number: NCT05961657
• Lead Sponsor: Fondazione IRCCS San Gerardo dei Tintori

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-06
• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-18
• Last Update Submitted: 2023-07-18
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Primary Completion: 2023-08-09
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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
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
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
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 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
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

Trial Locations

Locations (1)

Fondazione IRCCS San Gerardo dei Tintori; 🇮🇹 Monza, Monza E Brianza, Italy