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

NCT07633184 | Recruiting

• 1 other identifier: 405/2024/OSS/AUSLRE
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Bronchopulmonary Dysplasia

Keywords

respiratory morbidity; prematurity; dysplasia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  7 days, 14 days

Secondary Outcomes (3)

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

  7 days, 14 days

• Duration of invasive mechanical ventilation

  7 days, 14 days

• Duration of supplemental oxygen therapy

  7 days, 14 days

Study Arms (1)

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.

Diagnostic Test: Lung ultrasound at 7 (±1) days of life; Diagnostic Test: Lung ultrasound at 14 (±2) days of life

Interventions

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.

Preterm infants (<32 weeks' gestational age)

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.

Preterm infants (<32 weeks' gestational age)

Eligibility Criteria

• Age: Up to 31 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (4)

Neonatology and Neonatal Intensive Care Unit AOU Policlinico Modena

Modena, Italy

RECRUITING

Neonatology and Neonatal Intensive Care Unit AOU Padova

Padova, Italy

RECRUITING

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

Reggio Emilia, Italy

RECRUITING

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

Roma, Italy

RECRUITING

Related Publications (10)

• 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.

  PMID: 38087005 BACKGROUND

• Hoshino 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.

  PMID: 33374021 BACKGROUND

• Sun 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.

  PMID: 35305612 BACKGROUND

• Mohamed 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.

  PMID: 34237347 BACKGROUND

• Loi 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.

  PMID: 33352083 BACKGROUND

• Liu 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.

  PMID: 33755776 BACKGROUND

• Alonso-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.

  PMID: 33689782 BACKGROUND

• Oulego-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.

  PMID: 32665687 BACKGROUND

• Raimondi 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.

  PMID: 30127522 BACKGROUND

• Aldecoa-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.

  PMID: 34515177 BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Eleonora Balestri, MD

CONTACT

0522 296278; eleonora.baIestri@ausl.re.it

Ilaria Bassoli, MD

CONTACT

0522 296278; ilaria.bassoli@ausl.re.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 8, 2026
• Study Start: November 2, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-06

Locations

IT (4)