Multiparametric Bronchopulmonary Prediction (PARADYS)

Multiparametric Prediction of the Risk of Moderate-severe Bronchopulmonary Dysplasia in Neonates Born Before 30 Weeks of Gestation

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchopulmonary Dysplasia
• Intervention / Treatment: Diagnostic test: BPD prediction

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 d'Hebron 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 Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: Almudena Alonso-Ojembarrena, MD; Phone Number: +34670234337; Email: almudena.alonso.sspa@juntadeandalucia.es

Study Locations

• Spain
  • Cádiz
    • Cadiz, Cádiz, Spain, 11010
      • Recruiting
      • Hospital Universitario Puerta Del Mar
      • Contact: Almudena Alonso Ojembarrena, MD; Phone Number: +34670234337; Email: almudena.alonso.sspa@juntadeandalucia.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Neonates born before 30 weeks' gestation.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Neonates with severe chromosomal abnormalities, or severe congenital anomalies, infants who died prior to 36 weeks´ corrected age, as well as patients whose clinical condition prevents the performance of the study protocol ultrasounds.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Moderate-severe bronchopulmonary dysplasia; 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, with the diagnosis of moderate-severe bronchopulmonary dysplasia at 36 weeks' postmenstrual age.	Diagnostic test: BPD prediction; 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 in both aspirates at the same time.
no moderate-severe bronchopulmonary dysplasia; 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, without the diagnosis of moderate-severe bronchopulmonary dysplasia at 36 weeks' postmenstrual age.	Diagnostic test: BPD prediction; 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 in both aspirates at the same time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
multiparametric moderate-severe BPD prediction	• To assess if LUS and respiratory tract inflammatory parameters in the first week of life of preterm babies born before 30 weeks´ gestation, improves the predictive power of epidemiological and clinical variables for moderate-severe BPD.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
respiratory variables prediction by LUS	• To assess the predictive value of LUS in the first week of life in the diagnosis of moderate-severe BPD, the total duration of respiratory support, oxygen therapy and the need for home oxygen therapy.	7 days
Diffusion of the models obtained	• To create a website with a risk calculator for moderate-severe BPD in preterm infants of less than 30 weeks´ gestation, depending on the data obtained.	After 36 weeks' postmenstrual age

Collaborators and Investigators

• Sponsor: Andaluz Health Service
• Collaborators: University of Cadiz; European Society of Pediatric and Neonatal Intensive Care

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (ACTUAL): March 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 5, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Lung ultrasound, NICU, Premature, Proteomics
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Bronchopulmonary Dysplasia
• Other Study ID Numbers: NEO-LUS-20-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No