USCOM Parameters in Preterm Infants: Reference Ranges

Very Low Birth Weight Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961657
• Other study ID #: EmoNeo
• Status: Recruiting
• Start date: July 6, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: July 2023
• Source: Fondazione IRCCS San Gerardo dei Tintori
• Contact: Daniela Doni, MD
• Phone: +39039233
• Email: danieladoni9[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 1, 2023
• Est. primary completion date: August 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Days to 16 Days

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS San Gerardo dei Tintori	Monza	Monza E Brianza

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS San Gerardo dei Tintori

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Systemic Vascular Resistance Index at 7 days	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
Primary	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