Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04785859
Status:
RECRUITING
Last Update Posted:
2023-02-08
First Post:
2021-03-02
Brief Title:
Multiparametric Bronchopulmonary Prediction
Sponsor:
Andaluz Health Service
Organization:
Andaluz Health Service
Study Overview
Official Title:
Multiparametric Prediction of the Risk of Moderate-severe Bronchopulmonary Dysplasia in Neonates Born Before 30 Weeks of Gestation
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARADYS
Brief 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
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
Detailed Description:
Type of study case-control study Study population Neonates of less than 30 weeks gestation born at any of the study centers or transferred from other centers in the first 24 hours of life during the study period The participating hospitals will be Puerta del Mar University Hospital in Cádiz Basurto University Hospital in Bilbao Álvaro Cunqueiro University Hospital in Vigo Doctor Josep Trueta University Hospital in Girona Clínic University Hospital in Barcelona León University Hospital Gregorio Marañón University Hospital in Madrid German Trias i Pujol Hospital in Barcelona Miguel Servet Hospital in Zaragoza and Val dHebron Hospital in Barcelona
Study protocol The following lung ultrasounds will be performed on the patients included in the study first 24 hours of life 3rd day of life DOL and 7th DOL At one week of life detection of proteins in nasopharyngeal aspirates will be performed During the first week of life an echocardiography will be performed in all patients to evaluate the possibility of a patent ductus arteriosus and its hemodynamic significance
In the first 20 patients who remain intubated at one week of life tracheal aspirates will be obtained too to compare protein determination
Study protocol The following lung ultrasounds will be performed on the patients included in the study first 24 hours of life 3rd day of life DOL and 7th DOL At one week of life detection of proteins in nasopharyngeal aspirates will be performed During the first week of life an echocardiography will be performed in all patients to evaluate the possibility of a patent ductus arteriosus and its hemodynamic significance
In the first 20 patients who remain intubated at one week of life tracheal aspirates will be obtained too to compare protein determination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None