USCOM Parameters in Preterm Infants: Reference Ranges

NCT ID: NCT05961657

Last Updated: 2023-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-06

Study Completion Date

2023-09-01

Brief Summary

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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

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Conditions

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Very Low Birth Weight Infant Very Preterm Maturity of Infant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

2 Days

Maximum Eligible Age

16 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS San Gerardo dei Tintori

OTHER

Sponsor Role lead

Responsible Party

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Daniela Doni

Consultant Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniela Doni, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS San Gerardo dei Tintori

Locations

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Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza E Brianza, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Daniela Doni, MD

Role: CONTACT

+39039233 ext. 9173

Emanuela Zannin, PhD

Role: CONTACT

Facility Contacts

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Danial Donu, MD

Role: primary

+39039233 ext. 9173

Emanuela Zannin, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 32758264 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20605971 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31326967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21933558 (View on PubMed)

Other Identifiers

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EmoNeo

Identifier Type: -

Identifier Source: org_study_id

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