NCT04785859

Multiparametric Bronchopulmonary Prediction

Multiparametric Prediction of the Risk of Moderate-severe Bronchopulmonary Dysplasia in Neonates Born Before 30 Weeks of Gestation
Andaluz Health Service·ClinicalTrials.gov·diagnostic testRecruiting
View on ClinicalTrials.gov
Study focus
Drug/Device/Intervention
BPD prediction
Study type
Observational
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
Andaluz Health Service
Location
Cadiz, Spain
Timeline & enrollment
Phase
N/A
Start date
Dec 01, 2020
End date
Mar 01, 2024
Enrollment
240 participants
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
Bronchopulmonary dysplasia originating in the perinatal periodCongenital bronchomalaciaBronchopneumonia, unspecifiedOther congenital malformations of bronchusDiseases of bronchus, not elsewhere classified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04785859
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04785859 through Pure Global AI's free database. This phase not specified trial is sponsored by Andaluz Health Service and is currently Recruiting. The study focuses on Bronchopulmonary Dysplasia. Target enrollment is 240 participants.

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