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NCT Number: NCT07633184

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

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.

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Key information

Age range

Up to 31 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Neonatology and Neonatal Intensive Care Unit AOU Policlinico Modena, Modena, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung ultrasound at 7 (±1) days of life

Diagnostic Test

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 at 14 (±2) days of life

Diagnostic Test

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.

Primary outcomes

  1. Diagnostic accuracy of Lung Ultrasound for prediction of bronchopulmonary dysplasia

    Time frame: 7 days, 14 days

    Diagnostic performance of the Lung Ultrasound Score (LUS) for predicting bronchopulmonary dysplasia, defined according to both the Jobe/Bancalari and Jensen classifications.

  2. Diagnostic accuracy of Lung Ultrasound Score for prediction of moderate-to-severe bronchopulmonary dysplasia

    Time frame: 7 days, 14 days

    Diagnostic performance of the Lung Ultrasound Score obtained for predicting moderate-to-severe bronchopulmonary dysplasia.

Secondary outcomes

  1. Incidence of bronchopulmonary dysplasia according to pleural line abnormalities detected by lung ultrasound

    Time frame: 7 days, 14 days

    Incidence (%) of bronchopulmonary dysplasia in neonates with and without pleural line abnormalities detected by lung ultrasound (LUS)

  2. Duration of invasive mechanical ventilation

    Time frame: 7 days, 14 days

    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

  3. Duration of supplemental oxygen therapy

    Time frame: 7 days, 14 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eleonora Balestri, MD

CONTACT

[email protected]

0522 296278

Ilaria Bassoli, MD

CONTACT

[email protected]

0522 296278

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

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

Acronym: LUS_BPD

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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