Multiparametric Bronchopulmonary Prediction

NCT04785859 | Unknown

• 1 other identifier: NEO-LUS-20-01
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia

Keywords

Lung ultrasound, NICU, Premature, Proteomics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• respiratory variables prediction by LUS

  7 days

• Diffusion of the models obtained

  After 36 weeks' postmenstrual age

Study Arms (2)

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

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

Interventions

BPD prediction DIAGNOSTIC_TEST

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.

Moderate-severe bronchopulmonary dysplasia; no moderate-severe bronchopulmonary dysplasia

Eligibility Criteria

• Age: Up to 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Neonates born before 30 weeks' gestation.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andaluz Health Service: lead
• University of Cadiz: collaborator
• European Society of Pediatric and Neonatal Intensive Care: collaborator

Study Sites (1)

Hospital Universitario Puerta del Mar

Cadiz, Cádiz, 11010, Spain

RECRUITING

Related Publications (1)

• Garrido-Munoz F, Fernandez-Vega A, Gregorio-Hernandez R, Padin-Fontan M, Heras-Martin ML, Teresa-Palacio M, Alonso-Quintela P, Trujillo-Fagundo A, Perez-Perez A, Pumarada-Prieto M, Montero-Gato J, Aldecoa-Bilbao V, Oulego-Erroz I, Sanchez-Fernandez M, Alonso-Ojembarrena A. Proteomic Analysis of Nasopharyngeal Aspirate Biomarkers for Prematurity-Related Bronchopulmonary Dysplasia. Chest. 2025 Oct;168(4):980-993. doi: 10.1016/j.chest.2025.04.036. Epub 2025 May 12.

  PMID: 40368027 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal aspirates

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Almudena Alonso-Ojembarrena, MD

CONTACT

+34670234337; almudena.alonso.sspa@juntadeandalucia.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 8, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)