Clinical trial NCT05961657: USCOM Parameters in Preterm Infants: Reference Ranges
Official title: Hemodynamic Evaluation in Preterm Babies Using UltraSonic Cardiac Output Monitor (USCOM)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Very Low Birth Weight Infant
Very Preterm Maturity of Infant
Lead sponsor: Fondazione IRCCS San Gerardo dei Tintori
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Cardiac Output at 3 days
timeFrame: 3 ± 1 days of life
measure: Cardiac Output at 7 days
timeFrame: 7 ± 2 days of life
measure: Cardiac Output at 14 days
timeFrame: 14 ± 2 days of life
measure: Cardiac Index at 3 days
timeFrame: 3 ± 1 days of life
measure: Cardiac Index at 7 days
timeFrame: 7 ± 2 days of life
measure: Cardiac Index at 14 days
timeFrame: 14 ± 2 days of life
measure: Systemic Vascular Resistance Index at 3 days
timeFrame: 3 ± 1 days of life
measure: Systemic Vascular Resistance Index at 7 days
timeFrame: 7 ± 2 days of life
measure: Systemic Vascular Resistance Index at 14 days
timeFrame: 14 ± 2 days of life
Secondary outcomes:
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
state: Monza E Brianza
Study officials:
affiliation: Fondazione IRCCS San Gerardo dei Tintori
name: Daniela Doni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.