Lung Ultrasound Score for Early Prediction of Bronchopulmonary Dysplasia in Preterm Newborns (LUS_BPD)
2026年7月23日 更新者：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.
調査の概要
状態
募集
条件
詳細な説明
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.
研究の種類
観察的
入学 (推定)
40
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Eleonora Balestri, MD
- 電話番号：0522 296278
- メール：eleonora.baIestri@ausl.re.it
研究連絡先のバックアップ
- 名前：Ilaria Bassoli, MD
- 電話番号：0522 296278
- メール：ilaria.bassoli@ausl.re.it
研究場所
-
-
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Modena、イタリア
- 募集
- Neonatology and Neonatal Intensive Care Unit AOU Policlinico Modena
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コンタクト：
- Eugenio Spaggiari, MD
- 電話番号：0594222522
- メール：eugenio.spaggiari@aou.mo.it
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Padova、イタリア
- 募集
- Neonatology and Neonatal Intensive Care Unit AOU Padova
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コンタクト：
- Luca Bonadies, MD PhD
- 電話番号：049-8213578
- メール：luca.bonadies@unipd.it
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Reggio Emilia、イタリア
- 募集
- Neonatology and Neonatal Intensive Care Unit AUSL - IRCCS of Reggio Emilia
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コンタクト：
- Eleonora Balestri, MD
- 電話番号：0522 296278
- メール：eleonora.baIestri@ausl.re.it
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Roma、イタリア
- 募集
- Neonatology and Neonatal Intensive Care Unit Policlinico Universitario A. Gemelli IRCCS, Roma.
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コンタクト：
- Alessandro Perri, MD
- 電話番号：06 3015.4357
- メール：alessandro.perri@unicatt.it
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Consecutive preterm infants born at less than 32 weeks' gestational age and admitted to participating NICUs during the study period.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic accuracy of Lung Ultrasound for prediction of bronchopulmonary dysplasia
時間枠：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
時間枠：7 days, 14 days
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Diagnostic performance of the Lung Ultrasound Score obtained for predicting moderate-to-severe bronchopulmonary dysplasia.
|
7 days, 14 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Duration of invasive mechanical ventilation
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年11月2日
一次修了 (推定)
2027年2月1日
研究の完了 (推定)
2027年2月1日
試験登録日
最初に提出
2026年6月3日
QC基準を満たした最初の提出物
2026年6月3日
最初の投稿 (実際)
2026年6月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月24日
QC基準を満たした最後の更新が送信されました
2026年7月23日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 405/2024/OSS/AUSLRE
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