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

3 giugno 2026 aggiornato da: Azienda USL Reggio Emilia - IRCCS

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

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

40

Contatti e Sedi

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Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Italia
      • Modena, Italia
        • Reclutamento
        • Neonatology and Neonatal Intensive Care Unit AOU Policlinico Modena
        • Contatto:
      • Padova, Italia
        • Reclutamento
        • Neonatology and Neonatal Intensive Care Unit AOU Padova
        • Contatto:
      • Reggio Emilia, Italia
        • Reclutamento
        • Neonatology and Neonatal Intensive Care Unit AUSL - IRCCS of Reggio Emilia
        • Contatto:
      • Roma, Italia
        • Reclutamento
        • Neonatology and Neonatal Intensive Care Unit Policlinico Universitario A. Gemelli IRCCS, Roma.
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Consecutive preterm infants born at less than 32 weeks' gestational age and admitted to participating NICUs during the study period.

Descrizione

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

Piano di studio

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Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Preterm infants (<32 weeks' gestational age)
Consecutive preterm infants born at less than 32 weeks' gestational age and admitted to participating NICUs during the study period.
Test diagnostico: 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.
Test diagnostico: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diagnostic accuracy of Lung Ultrasound for prediction of bronchopulmonary dysplasia
Lasso di tempo: 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.
7 days, 14 days
Diagnostic accuracy of Lung Ultrasound Score for prediction of moderate-to-severe bronchopulmonary dysplasia
Lasso di tempo: 7 days, 14 days
Diagnostic performance of the Lung Ultrasound Score obtained for predicting moderate-to-severe bronchopulmonary dysplasia.
7 days, 14 days

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Association between pleural line abnormalities and bronchopulmonary dysplasia
Lasso di tempo: 7 days, 14 days
Association between the presence of pleural line abnormalities detected by lung ultrasound and subsequent diagnosis of bronchopulmonary dysplasia.
7 days, 14 days
Duration of invasive mechanical ventilation
Lasso di tempo: 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
7 days, 14 days
Duration of supplemental oxygen therapy
Lasso di tempo: 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.
7 days, 14 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Azienda USL Reggio Emilia - IRCCS

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 novembre 2024

Completamento primario (Stimato)

1 febbraio 2027

Completamento dello studio (Stimato)

1 febbraio 2027

Date di iscrizione allo studio

Primo inviato

3 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2026

Primo Inserito (Effettivo)

8 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 405/2024/OSS/AUSLRE

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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