USCOM Parameters in Preterm Infants: Reference Ranges

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

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.

Study Overview

• Status: Recruiting
• Conditions: Very Low Birth Weight Infant; Very Preterm Maturity of Infant
• Intervention / Treatment: Diagnostic test: Hemodynamic measurements by USCOM

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Daniela Doni, MD; Phone Number: 9173 +39039233; Email: danieladoni9@gmail.com
• Study Contact Backup: Name: Emanuela Zannin, PhD; Email: emanuela.zannin@gmail.com

Study Locations

• Italy
  • Monza E Brianza
    • Monza, Monza E Brianza, Italy, 20900
      • Recruiting
      • Fondazione IRCCS San Gerardo dei Tintori
      • Contact: Emanuela Zannin, PhD; Email: emanuela.zannin@gmail.com
      • Contact: Danial Donu, MD; Phone Number: 9173 +39039233; Email: danieladoni9@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fondazione IRCCS San Gerardo dei Tintori
• Investigators: Principal Investigator: Daniela Doni, MD, Fondazione IRCCS San Gerardo dei Tintori

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Estimated): August 9, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Birth Weight
• Other Study ID Numbers: EmoNeo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No