Multiparametric Bronchopulmonary Prediction - Trial NCT04785859

Timeline & Enrollment

Primary Outcome

multiparametric moderate-severe BPD prediction

Summary

INTRODUCTION: Current Neonatology has failed to reduce the incidence of moderate-severe
 bronchopulmonary dysplasia (BPD). Although multiple models for predicting the risk of
 dysplasia in preterm infants have been studied, none have been implemented in clinical
 practice.
 
 OBJECTIVE: To calculate a mathematical model to predict moderate-severe bronchopulmonary
 dysplasia in newborns before 30 weeks of gestation based on pre and postnatal clinical
 variables, lung ultrasound images and detection of biomarkers in nasopharyngeal aspirate.
 
 METHODOLOGY: Multicenter case-control study, in which 10 Spanish neonatal intensive care
 units (NICU) will participate. All participants will undergo a lung ultrasound in the first
 24 hours, on the third day of life, at one week and two weeks of life, a nasopharyngeal
 aspirate at one week of life, and cardiac ultrasound at one week and two weeks of life. It is
 expected to include 240 patients in 29 months of study among all participating units: 200 for
 the calculation of the model, and 40 more for its subsequent validation. These will be
 divided between those with a diagnosis of moderate-severe BPD and those without, and the
 values of each of the variables described in the methodology section will be compared between
 the two groups. Those with a significant difference will be entered into a logistic
 regression model to calculate those that best predict the final diagnosis. With the results
 of the calculated model, a mobile application will be created with a risk of moderate-severe
 BPD calculator in this population, for its worldwide distribution.

ICD-10 Classifications