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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 7 months
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Neonatology and Neonatal Intensive Care Unit AOU Policlinico Modena
RECRUITING
Modena
Neonatology and Neonatal Intensive Care Unit AOU Padova
RECRUITING
Padova
Neonatology and Neonatal Intensive Care Unit AUSL - IRCCS of Reggio Emilia
RECRUITING
Reggio Emilia
Neonatology and Neonatal Intensive Care Unit Policlinico Universitario A. Gemelli IRCCS, Roma.
RECRUITING
Roma
Contact Information
Primary
Eleonora Balestri, MD
eleonora.baIestri@ausl.re.it
0522 296278
Backup
Ilaria Bassoli, MD
ilaria.bassoli@ausl.re.it
0522 296278
Time Frame
Start Date: 2024-11-02
Estimated Completion Date: 2027-02
Participants
Target number of participants: 40
Treatments
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.
Sponsors
Leads: Azienda USL Reggio Emilia - IRCCS

This content was sourced from clinicaltrials.gov

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