An observational study in Bronchopulmonary Dysplasia, sponsored by Azienda USL Reggio Emilia - IRCCS. Recruiting at 4 sites in Italy. Open to participants aged Up to 31 Weeks. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Azienda USL Reggio Emilia - IRCCS · Observational
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.
Bronchopulmonary dysplasia (BPD) is one of the most frequent and severe complications of extreme prematurity and remains a major cause of neonatal morbidity despite significant advances in perinatal and neonatal care. BPD is associated with long-term respiratory, cardiovascular, and neurodevelopmental complications and continues to affect a substantial proportion of infants born at very low gestational ages. Current diagnostic definitions of BPD rely on the need for respiratory support at 36 weeks postmenstrual age. Consequently, diagnosis is established after the period during which preventive and disease-modifying interventions are likely to be most effective. Evidence suggests that irreversible structural changes of the developing lung may occur within the first weeks of life, making early identification of infants at high risk of BPD a clinical priority. Lung ultrasound (LUS) has emerged as a safe, non-invasive, bedside imaging modality capable of assessing lung aeration and pulmonary abnormalities in preterm infants. The Lung Ultrasound Score (LUS) provides a quantitative evaluation of lung aeration loss and has shown promising results in predicting respiratory outcomes in neonatal populations. In addition, pleural line abnormalities, including thickening, irregularity, fragmentation, and subpleural consolidations, have been associated with the subsequent development of BPD. Although several studies have suggested that lung ultrasound findings obtained during the first two weeks of life may predict BPD, no standardized and universally accepted method for early risk stratification is currently available. Furthermore, the optimal ultrasound parameters and their predictive performance remain uncertain. The first 15 days of life represent a critical window for assessing the risk of BPD and for identifying infants who may benefit from preventive therapeutic strategies before irreversible lung injury develops. The aim of this study is to evaluate whether lung ultrasound findings obtained during the first two weeks of life, including Lung Ultrasound Score and pleural line characteristics, are associated with the subsequent development of BPD and may therefore serve as early prognostic markers. Because two clinical definitions of BPD are currently widely used in clinical practice and research, and no clear evidence has demonstrated the superiority of one definition over the other for diagnostic or prognostic purposes, both the Jobe and Bancalari definition and the Jensen definition will be applied in this study. The primary objective is to evaluate the diagnostic performance of the Lung Ultrasound Score measured at 7 and 14 days of life for the prediction of BPD and moderate-to-severe BPD in preterm infants.
362 studies on the registry are indexed under Bronchopulmonary Dysplasia; 85 are open to participants now.
This study's planned enrollment of 40 is below the median of 150 across 99 observational studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →Azienda USL Reggio Emilia - IRCCS is the lead sponsor of 93 studies on the registry; 26 are open to participants now.
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Consecutive preterm infants born at less than 32 weeks' gestational age and admitted to participating NICUs during the study period.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Consecutive preterm infants born at less than 32 weeks' gestational age and admitted to participating NICUs during the study period.
Diagnostic Test: Lung ultrasound at 7 (±1) days of life · Diagnostic Test: Lung ultrasound at 14 (±2) days of life
Lung ultrasound will be performed at 7 (±1) days days of life by physicians experienced in lung ultrasound, defined as any physician who has previously completed a theoretical and practical training course in lung ultrasound and has independently performed at least 20 lung ultrasound examinations. Six thoracic regions will be examined in order to determine the Lung Ultrasound Score (LUS) and to assess pleural line characteristics: right and left anterior superior, right and left anterior inferior, and right and left lateral regions.
Lung ultrasound will be performed at 14 (±2) days days of life by physicians experienced in lung ultrasound, defined as any physician who has previously completed a theoretical and practical training course in lung ultrasound and has independently performed at least 20 lung ultrasound examinations. Six thoracic regions will be examined in order to determine the Lung Ultrasound Score (LUS) and to assess pleural line characteristics: right and left anterior superior, right and left anterior inferior, and right and left lateral regions.
Diagnostic accuracy of Lung Ultrasound for prediction of bronchopulmonary dysplasia
Diagnostic performance of the Lung Ultrasound Score (LUS) for predicting bronchopulmonary dysplasia, defined according to both the Jobe/Bancalari and Jensen classifications.
Time frame: 7 days, 14 days
Diagnostic accuracy of Lung Ultrasound Score for prediction of moderate-to-severe bronchopulmonary dysplasia
Diagnostic performance of the Lung Ultrasound Score obtained for predicting moderate-to-severe bronchopulmonary dysplasia.
Time frame: 7 days, 14 days
Incidence of bronchopulmonary dysplasia according to pleural line abnormalities detected by lung ultrasound
Incidence (%) of bronchopulmonary dysplasia in neonates with and without pleural line abnormalities detected by lung ultrasound (LUS)
Time frame: 7 days, 14 days
Duration of invasive mechanical ventilation
Association between Lung Ultrasound Score (LUS) obtained during the first two weeks of life and the total duration of invasive mechanical ventilation in preterm infants
Time frame: 7 days, 14 days
Duration of supplemental oxygen therapy
Association between Lung Ultrasound Score (LUS) obtained during the first two weeks of life and the total duration of supplemental oxygen therapy in preterm infants.
Time frame: 7 days, 14 days
Started Nov 2024 (actual). Primary completion is estimated for Feb 2027, 27 months after the start.
Of 46 non-industry observational studies under Bronchopulmonary Dysplasia, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 84. This study's planned 27 months is below that.
Counting every sponsor, half of 48 studies reached it within 56 months; a quarter within 19 and three quarters within 84.
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Azienda USL Reggio Emilia - IRCCS