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RECRUITING
NCT07633184

Lung Ultrasound Score for Early Prediction of Bronchopulmonary Dysplasia in Preterm Newborns

Sponsor: Azienda USL Reggio Emilia - IRCCS

View on ClinicalTrials.gov

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.

Official title: Lung Ultrasound Score (LUS) as Early Predictor of Bronchopulmonary Dysplasia (BPD) in Preterm Newborns: A Prospective, Multicenter, Observational Study

Key Details

Gender

All

Age Range

Any - 31 Weeks

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2024-11-02

Completion Date

2027-02

Last Updated

2026-06-08

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Lung ultrasound at 7 (±1) 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.

DIAGNOSTIC_TEST

Lung ultrasound at 14 (±2) days of life

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.

Locations (4)

Neonatology and Neonatal Intensive Care Unit AOU Policlinico Modena

Modena, Italy

Neonatology and Neonatal Intensive Care Unit AOU Padova

Padova, Italy

Neonatology and Neonatal Intensive Care Unit AUSL - IRCCS of Reggio Emilia

Reggio Emilia, Italy

Neonatology and Neonatal Intensive Care Unit Policlinico Universitario A. Gemelli IRCCS, Roma.

Roma, Italy