Measuring heart function in very preterm and low birth weight infants
Hemodynamic Evaluation in Preterm Babies Using UltraSonic Cardiac Output Monitor (USCOM)
This study is testing if a special heart monitor can safely measure heart function in very preterm and low birth weight infants to help doctors understand their health better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 2 Days to 16 Days |
| Sex | All |
| Sponsor | Fondazione IRCCS San Gerardo dei Tintori Academic / other |
| Locations | 1 site (Monza, Monza E Brianza) |
| Trial ID | NCT05961657 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the feasibility of using the UltraSonic Cardiac Output Monitor (USCOM) to measure hemodynamic parameters in very preterm infants or those with very low birth weight. It seeks to establish reference ranges for these measurements, evaluate how various patient characteristics may influence the results, and determine the repeatability of the measurements over time. Participants will undergo USCOM assessments on their 3rd, 7th, and 14th postnatal days to gather comprehensive data.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born before 32 weeks of gestation or with a birth weight below 1500 grams.
Not a fit: Patients with congenital heart diseases or those requiring medications that affect hemodynamics will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical reference ranges for hemodynamic monitoring in vulnerable infant populations, improving clinical care.
How similar studies have performed: While there may be studies on hemodynamic monitoring in infants, this specific approach using USCOM in very preterm and low birth weight infants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Monza, Monza E Brianza
- Fondazione IRCCS San Gerardo dei Tintori — Monza, Monza E Brianza, Italy (Recruiting)
Study contacts
- Principal investigator: Daniela Doni, MD — Fondazione IRCCS San Gerardo dei Tintori
- Study coordinator: Daniela Doni, MD
- Email: danieladoni9@gmail.com
- Phone: +39039233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.