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Search / Trial NCT05961657

USCOM Parameters in Preterm Infants: Reference Ranges

Launched by FONDAZIONE IRCCS SAN GERARDO DEI TINTORI · Jul 18, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how to measure the heart and blood flow in very premature or very low birth weight infants using a special device called the UltraSonic Cardiac Output Monitor (USCOM). The researchers want to find out what normal measurements should look like for these tiny babies, how their individual characteristics might affect these readings, and if the measurements are consistent when taken at different times. This study is important because it can help doctors better understand and care for these vulnerable infants.

To participate in this study, babies must be born before 32 weeks of pregnancy or weigh less than 1500 grams at birth. However, babies with certain heart conditions or those needing specific medications that affect blood flow cannot join. If your baby is eligible, they will have USCOM measurements taken on days 3, 7, and 14 after birth. This is a great opportunity to contribute to important research that may improve care for future preterm infants.

Gender

ALL

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)

About Fondazione Irccs San Gerardo Dei Tintori

Fondazione IRCCS San Gerardo dei Tintori is a leading research institution in Italy dedicated to advancing healthcare through innovative clinical trials and translational research. Affiliated with the Italian National Health Service, the foundation focuses on a wide range of medical disciplines, emphasizing patient-centered approaches and multidisciplinary collaboration. With a commitment to improving clinical outcomes, the foundation actively engages in the development and implementation of cutting-edge therapies and medical technologies, striving to enhance the quality of life for patients while contributing to the global medical community.

Locations

Monza, Monza E Brianza, Italy

Patients applied

0 patients applied

Trial Officials

Daniela Doni, MD

Principal Investigator

Fondazione IRCCS San Gerardo dei Tintori

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported