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

Recruitingn/aAges any - 31 WeeksAllAzienda USL Reggio Emilia - IRCCS
NCT07633184 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, bed

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📋 Eligibility rules (as published)
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
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What it tests

  • Lung ultrasound at 7 (±1) days of life
  • Lung ultrasound at 14 (±2) days of life
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Where

4 sites
Neonatology and Neonatal Intensive Care Unit AOU Policlinico Modena
Modena, Italy
Neonatology and Neonatal Intensive Care Unit AOU Padova
Padova, Italy
Neonatology and Neonatal Intensive Care Unit AUSL - IRCCS of Reggio Emilia
Reggio Emilia, Italy
Neonatology and Neonatal Intensive Care Unit Policlinico Universitario A. Gemelli IRCCS, Roma.
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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