Clinical trial Recruiting at 4 sites Observational Ages Any age to 31 Weeks

Lung Ultrasound Score to predict BPD in very preterm babies

Official title: Lung Ultrasound Score (LUS) as Early Predictor of Bronchopulmonary Dysplasia (BPD) in Preterm Newborns: A Prospective, Multicenter, Observational Study

Run by Azienda USL Reggio Emilia - IRCCS · NCT07633184 · Data updated 2026-11-12

This study tests whether lung ultrasound scores in the first two weeks of life can predict which extremely preterm babies will develop bronchopulmonary dysplasia.

Quick facts

Study typeObservational
AgesAny age to 31 Weeks
SexAll
Enrollment40 (estimated)
SponsorAzienda USL Reggio Emilia - IRCCS
Government
Drugs / interventionsradiation
Locations4 sites (Modena and 3 other locations)
StatusRecruiting
StartedNovember 2, 2024
Main results expectedFebruary 2027
Study endsFebruary 2027
Registry record updatedJuly 24, 2026
Trial IDNCT07633184 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Very preterm infants born at less than 32 weeks' gestation, admitted to participating neonatology units within the first week of life, whose guardians consent to participation.

Probably not a fit

Newborns not at high likelihood of BPD based on early ultrasound patterns or those who do not survive to 36 weeks may derive no predictive benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses lung ultrasound performed at about 7 and 14 days after birth to identify early lung‑aeration patterns that may predict bronchopulmonary dysplasia in infants born before 32 weeks. The Lung Ultrasound Score quantifies aeration loss and pleural line abnormalities to help forecast later respiratory outcomes. The goal is to enable earlier, targeted interventions by identifying high‑risk infants before 36 weeks postmenstrual age. Data are collected from multiple neonatal centers to evaluate the association between early LUS findings and subsequent BPD development. No therapeutic interventions are assigned as part of this observational assessment.

Why it matters

Potential benefit: If successful, the approach could allow earlier risk stratification and prompt preventive strategies for babies at highest risk of BPD.

How similar studies have gone: Prior research has shown promising links between early LUS findings and later respiratory outcomes in preterm infants, supporting this predictive approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • 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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.