NCT07265583 Early Prediction of Lung Injury in Preterm Infants Score
| NCT ID | NCT07265583 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
| Condition | Respiratory Distress Syndrome RDS |
| Study Type | OBSERVATIONAL |
| Enrollment | 104 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 104 participants in total. It began in 2025-10-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main hypothesis is that even preterm infants considered "stable" receiving non-invasive ventilation may be at risk of developing BPD due to an inhomogeneous distribution of ventilation. Identifying this characteristic from the first days of life by using EIT could, in the future, optimize non-invasive ventilation strategies as early as possible, such as lung recruitment manoeuvres, which are currently mainly used during invasive mechanical ventilation. In addition, comparing the LUS scores and homogeneity parameters derived from the EIT may help to further confirm the role of semi-quantitative lung ultrasound as a rapid, non-invasive, and readily available tool in NICUs for monitoring the lung function of preterm infants in the short and long term. The primary objective is to measure homogeneity by Electrical Impedance Tomography (EIT) technology, used in the first weeks of life, for the development of BPD of grade 3, at 36 weeks postmenstrual age or death, in stable preterm infants requiring non-invasive ventilation. The secondary objective are to score if homogeneity at EIT are present and whether if they are associated with BPD. to ompare the distribution of regional lung ventilation obtained by EIT with the validated LUS scores.
Eligibility Criteria
Inclusion Criteria: preterm infants born between 26 and 32 weeks of gestational age and/or with a birth weight \< 1500g (very low birth weight infants - VLBW) with respiratory distress syndrome (RDS). \- Exclusion Criteria: - outborn infants * complex congenital malformations * metabolic, chromosomal, or other genetic abnormalities * pulmonary hypoplasia, congenital anomalies of surfactant proteins or other pulmonary abnormalities * any skin anomalies * need for mechanical ventilation \> 72h after birth * any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion. * lack of parent consent.
Contact & Investigator
Stefano Ghirardello, MD
PRINCIPAL INVESTIGATOR
NICU, Fondazione IRCCS Policlinico San Matteo
Frequently Asked Questions
Who can join the NCT07265583 clinical trial?
This trial is open to participants of all sexes, aged 26 Weeks or older, up to 32 Weeks, studying Respiratory Distress Syndrome RDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07265583 currently recruiting?
Yes, NCT07265583 is actively recruiting participants. Contact the research team at s.ghirardello@smatteo.pv.it for enrollment information.
Where is the NCT07265583 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT07265583 clinical trial?
NCT07265583 is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. The principal investigator is Stefano Ghirardello, MD at NICU, Fondazione IRCCS Policlinico San Matteo. The trial plans to enroll 104 participants.