Bronchopulmonary DysplasiaLUS_BPDNCT07633184
Lung Ultrasound Score for Early Prediction of Bronchopulmonary Dysplasia in Preterm Newborns
An observational study of Bronchopulmonary Dysplasia, run by Azienda USL Reggio Emilia - IRCCS at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 31 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Lung ultrasound at 7 (±1) days of life and Lung ultrasound at 14 (±2) days of life
- How many people
- 40 participants
- Where
- 4 sitesItaly
- Study dates
- 2 Nov 2024to Feb 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 31 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Consecutive preterm infants born at less than 32 weeks' gestational age and admitted to participating NICUs during the study period.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Recruiting
Neonatology and Neonatal Intensive Care Unit AOU Policlinico Modena
Modena
Eugenio Spaggiari, MD, 0594222522, eugenio.spaggiari@aou.mo.it
- Recruiting
Neonatology and Neonatal Intensive Care Unit AOU Padova
Padova
Luca Bonadies, MD PhD, 049-8213578, luca.bonadies@unipd.it
- Recruiting
Neonatology and Neonatal Intensive Care Unit AUSL - IRCCS of Reggio Emilia
Reggio Emilia
Eleonora Balestri, MD, 0522 296278, eleonora.baIestri@ausl.re.it
- Recruiting
Neonatology and Neonatal Intensive Care Unit Policlinico Universitario A. Gemelli IRCCS, Roma.
Roma
Alessandro Perri, MD, 06 3015.4357, alessandro.perri@unicatt.it
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Lung ultrasound at 7 (±1) days of life, Lung ultrasound at 14 (±2) days of life
- Keywords
- respiratory morbidity, prematurity, dysplasia
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasound at 7 (±1) days of lifeDiagnostic 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 lifeDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Lung ultrasound at 7 (±1) days of life; Diagnostic Test: Lung ultrasound at 14 (±2) days of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 days, 14 days
Secondary outcomes (3)
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)
Measured: 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
Measured: 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.
Measured: 7 days, 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start2 Nov 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633184
- Sponsor's protocol ID
- 405/2024/OSS/AUSLRE
- Acronym
- LUS_BPD
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Zong H, Huang Z, Fu Y, Chen X, Yu Y, Huang Y, Huang Y, Sun H, Yang C. Lung ultrasound score as a tool to predict severity of bronchopulmonary dysplasia in neonates born </=25 weeks of gestational age. J Perinatol. 2024 Feb;44(2):273-279. doi: 10.1038/s41372-023-01811-4. Epub 2023 Dec 12.
PubMed 38087005Hoshino Y, Arai J, Miura R, Takeuchi S, Yukitake Y, Kajikawa D, Kamakura T, Horigome H. Lung Ultrasound for Predicting the Respiratory Outcome in Patients with Bronchopulmonary Dysplasia. Am J Perinatol. 2022 Aug;39(11):1229-1235. doi: 10.1055/s-0040-1721848. Epub 2020 Dec 29.
PubMed 33374021Sun YH, Du Y, Shen JR, Ai DY, Huang XY, Diao SH, Lin SB, Zhang R, Yuan L, Yang YP, He LL, Qin XJ, Zhou JG, Chen C. A modified lung ultrasound score to evaluate short-term clinical outcomes of bronchopulmonary dysplasia. BMC Pulm Med. 2022 Mar 19;22(1):95. doi: 10.1186/s12890-022-01885-4.
PubMed 35305612Mohamed A, Mohsen N, Diambomba Y, Lashin A, Louis D, Elsayed Y, Shah PS. Lung Ultrasound for Prediction of Bronchopulmonary Dysplasia in Extreme Preterm Neonates: A Prospective Diagnostic Cohort Study. J Pediatr. 2021 Nov;238:187-192.e2. doi: 10.1016/j.jpeds.2021.06.079. Epub 2021 Jul 6.
PubMed 34237347Loi B, Vigo G, Baraldi E, Raimondi F, Carnielli VP, Mosca F, De Luca D. Lung Ultrasound to Monitor Extremely Preterm Infants and Predict Bronchopulmonary Dysplasia. A Multicenter Longitudinal Cohort Study. Am J Respir Crit Care Med. 2021 Jun 1;203(11):1398-1409. doi: 10.1164/rccm.202008-3131OC.
PubMed 33352083Liu X, Lv X, Jin D, Li H, Wu H. Lung ultrasound predicts the development of bronchopulmonary dysplasia: a prospective observational diagnostic accuracy study. Eur J Pediatr. 2021 Sep;180(9):2781-2789. doi: 10.1007/s00431-021-04021-2. Epub 2021 Mar 23.
PubMed 33755776Alonso-Ojembarrena A, Serna-Guerediaga I, Aldecoa-Bilbao V, Gregorio-Hernandez R, Alonso-Quintela P, Concheiro-Guisan A, Ramos-Rodriguez A, de Las Heras-Martin M, Rodeno-Fernandez L, Oulego-Erroz I. The Predictive Value of Lung Ultrasound Scores in Developing Bronchopulmonary Dysplasia: A Prospective Multicenter Diagnostic Accuracy Study. Chest. 2021 Sep;160(3):1006-1016. doi: 10.1016/j.chest.2021.02.066. Epub 2021 Mar 6.
PubMed 33689782Oulego-Erroz I, Alonso-Quintela P, Terroba-Seara S, Jimenez-Gonzalez A, Rodriguez-Blanco S. Early assessment of lung aeration using an ultrasound score as a biomarker of developing bronchopulmonary dysplasia: a prospective observational study. J Perinatol. 2021 Jan;41(1):62-68. doi: 10.1038/s41372-020-0724-z. Epub 2020 Jul 14.
PubMed 32665687Raimondi F, Yousef N, Migliaro F, Capasso L, De Luca D. Point-of-care lung ultrasound in neonatology: classification into descriptive and functional applications. Pediatr Res. 2021 Sep;90(3):524-531. doi: 10.1038/s41390-018-0114-9. Epub 2018 Jul 20.
PubMed 30127522Aldecoa-Bilbao V, Velilla M, Teresa-Palacio M, Esponera CB, Barbero AH, Sin-Soler M, Sanz MI, Salvia Roiges MD. Lung Ultrasound in Bronchopulmonary Dysplasia: Patterns and Predictors in Very Preterm Infants. Neonatology. 2021;118(5):537-545. doi: 10.1159/000517585. Epub 2021 Aug 13.
PubMed 34515177