About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial population
Consecutive preterm infants born at less than 32 weeks' gestational age and admitted to participating NICUs during the study period.
Trial design
Cohort
Prospective
Treatments tested in this trial
Lung ultrasound at 7 (±1) days of life
Diagnostic testLung 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 at 14 (±2) days of life
Diagnostic testLung 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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)
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
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.
Sponsors and contacts
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