Lung Ultrasound Score for Early Prediction of Bronchopulmonary Dysplasia in Preterm Newborns (LUS_BPD)
2026년 7월 23일 업데이트: 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.
연구 개요
상태
모병
정황
상세 설명
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.
연구 유형
관찰
등록 (추정된)
40
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Eleonora Balestri, MD
- 전화번호: 0522 296278
- 이메일: eleonora.baIestri@ausl.re.it
연구 연락처 백업
- 이름: Ilaria Bassoli, MD
- 전화번호: 0522 296278
- 이메일: ilaria.bassoli@ausl.re.it
연구 장소
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Modena, 이탈리아
- 모병
- Neonatology and Neonatal Intensive Care Unit AOU Policlinico Modena
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연락하다:
- Eugenio Spaggiari, MD
- 전화번호: 0594222522
- 이메일: eugenio.spaggiari@aou.mo.it
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Padova, 이탈리아
- 모병
- Neonatology and Neonatal Intensive Care Unit AOU Padova
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연락하다:
- Luca Bonadies, MD PhD
- 전화번호: 049-8213578
- 이메일: luca.bonadies@unipd.it
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Reggio Emilia, 이탈리아
- 모병
- Neonatology and Neonatal Intensive Care Unit AUSL - IRCCS of Reggio Emilia
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연락하다:
- Eleonora Balestri, MD
- 전화번호: 0522 296278
- 이메일: eleonora.baIestri@ausl.re.it
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Roma, 이탈리아
- 모병
- Neonatology and Neonatal Intensive Care Unit Policlinico Universitario A. Gemelli IRCCS, Roma.
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연락하다:
- Alessandro Perri, MD
- 전화번호: 06 3015.4357
- 이메일: alessandro.perri@unicatt.it
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
Consecutive preterm infants born at less than 32 weeks' gestational age and admitted to participating NICUs during the study period.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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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 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Diagnostic accuracy of Lung Ultrasound for prediction of bronchopulmonary dysplasia
기간: 7 days, 14 days
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Diagnostic performance of the Lung Ultrasound Score (LUS) for predicting bronchopulmonary dysplasia, defined according to both the Jobe/Bancalari and Jensen classifications.
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7 days, 14 days
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Diagnostic accuracy of Lung Ultrasound Score for prediction of moderate-to-severe bronchopulmonary dysplasia
기간: 7 days, 14 days
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Diagnostic performance of the Lung Ultrasound Score obtained for predicting moderate-to-severe bronchopulmonary dysplasia.
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7 days, 14 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Duration of invasive mechanical ventilation
기간: 7 days, 14 days
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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
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7 days, 14 days
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Duration of supplemental oxygen therapy
기간: 7 days, 14 days
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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.
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7 days, 14 days
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Incidence of bronchopulmonary dysplasia according to pleural line abnormalities detected by lung ultrasound
기간: 7 days, 14 days
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Incidence (%) of bronchopulmonary dysplasia in neonates with and without pleural line abnormalities detected by lung ultrasound (LUS)
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7 days, 14 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2024년 11월 2일
기본 완료 (추정된)
2027년 2월 1일
연구 완료 (추정된)
2027년 2월 1일
연구 등록 날짜
최초 제출
2026년 6월 3일
QC 기준을 충족하는 최초 제출
2026년 6월 3일
처음 게시됨 (실제)
2026년 6월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 23일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 405/2024/OSS/AUSLRE
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