NCT07633184 Lung Ultrasound Score for Early Prediction of Bronchopulmonary Dysplasia in Preterm Newborns
| NCT ID | NCT07633184 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda USL Reggio Emilia - IRCCS |
| Condition | Bronchopulmonary Dysplasia |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-11-02 |
| Primary Completion | 2027-02 |
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 40 participants in total. It began in 2024-11-02 with a primary completion date of 2027-02.
⚠ 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
Bronchopulmonary dysplasia (BPD) is one of the most common and severe complications of extreme prematurity, affecting approximately 40% of infants born before 28 weeks of gestation. Despite advances in neonatal care and improved survival rates for extremely preterm infants, the incidence of BPD remains high. BPD is associated with significant short- and long-term morbidity, including chronic respiratory impairment, pulmonary hypertension, recurrent respiratory infections, and neurodevelopmental sequelae. Current diagnosis of BPD is based on the need for respiratory support at 36 weeks postmenstrual age, limiting opportunities for early therapeutic intervention. Since structural lung injury may become irreversible within the first weeks of life, the identification of reliable early predictors of BPD is a major clinical priority. Lung ultrasound (LUS) is a non-invasive, radiation-free, bedside imaging technique increasingly used in neonatal intensive care units. The Lung Ultrasound Score (LUS) provides a quantitative assessment of lung aeration and has demonstrated utility in predicting several neonatal respiratory outcomes. Recent studies suggest that both LUS and pleural line abnormalities detected during the first weeks of life may be associated with the subsequent development of BPD, although evidence remains heterogeneous and no universally validated predictive method is currently available.
Eligibility Criteria
Inclusion Criteria: * born at less than 32 weeks' gestational age; * born in the Neonatology Department of one of the centres participating in the study or transferred there from another hospital within the first week of life; * parents/guardians have signed an informed consent form regarding the inclusion of thenewborn in the study and consent to the processing of personal data Exclusion Criteria: * major malformations,chromosomal abnormalities, congenital chest wall deformities, congenital heart defects, pulmonary hypoplasia, diaphragmatic hernia, suspected muscular dystrophy or neurological disorders that may impair lung development; * receipt of palliative care from birth; * death before 36 weeks' gestational age; * inability to perform a chest ultrasound or to adequately examine all 6 lung fields at both 7 (+/-1) and 14 (+/-2) days for any intervening reason; * inability to collect the data necessary to formulate a diagnosis of BPD within the duration of the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07633184 clinical trial?
This trial is open to participants of all sexes, up to 31 Weeks, studying Bronchopulmonary Dysplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07633184 currently recruiting?
Yes, NCT07633184 is actively recruiting participants. Contact the research team at eleonora.baIestri@ausl.re.it for enrollment information.
Where is the NCT07633184 trial being conducted?
This trial is being conducted at Modena, Italy, Padova, Italy, Reggio Emilia, Italy, Roma, Italy.
Who is sponsoring the NCT07633184 clinical trial?
NCT07633184 is sponsored by Azienda USL Reggio Emilia - IRCCS. The trial plans to enroll 40 participants.