USCOM Parameters in Preterm Infants: Reference Ranges

NCT05961657 | Unknown

• 1 other identifier: EmoNeo
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Very Low Birth Weight Infant; Very Preterm Maturity of Infant

Outcome Measures

Primary Outcomes (9)

• 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

Interventions

Hemodynamic measurements by USCOM DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 2 Days - 16 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• gestational age at birth below 32 weeks and/or
• birth weight (BW) below 1500 g

You may not qualify if:

• congenital heart diseases,
• hemodynamic instability requiring drugs that affect hemodynamics (e.g., inotropes)

Sponsors & Collaborators

• Fondazione IRCCS San Gerardo dei Tintori: lead

Study Sites (1)

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza E Brianza, 20900, Italy

RECRUITING

Related 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.

  PMID: 32758264 BACKGROUND

• 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.

  PMID: 20605971 BACKGROUND

• 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.

  PMID: 31326967 BACKGROUND

• 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.

  PMID: 21933558 BACKGROUND

Study Officials

• Daniela Doni, MD

  Fondazione IRCCS San Gerardo dei Tintori

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Doni, MD

CONTACT

+39039233; danieladoni9@gmail.com

Emanuela Zannin, PhD

CONTACT

emanuela.zannin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neonatologist

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: July 6, 2023
• Primary Completion: August 9, 2023
• Study Completion: September 1, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)