Lung Ultrasound Score for Early Prediction of Bronchopulmonary Dysplasia in Preterm Newborns (NCT07633184) | Clinical Trial Compass
RecruitingNot Applicable
Lung Ultrasound Score for Early Prediction of Bronchopulmonary Dysplasia in Preterm Newborns
Italy40 participantsStarted 2024-11-02
Plain-language 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.
Who can participate
Age range
31 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic accuracy of Lung Ultrasound for prediction of bronchopulmonary dysplasia
Timeframe: 7 days, 14 days
2
Diagnostic accuracy of Lung Ultrasound Score for prediction of moderate-to-severe bronchopulmonary dysplasia