Bronchopulmonary DysplasiaPARADYSNCT04785859
Multiparametric Bronchopulmonary Prediction
An observational study of Bronchopulmonary Dysplasia, run by Andaluz Health Service at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- BPD prediction
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2020to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- No healthy volunteers
- Child
Study population: Neonates born before 30 weeks' gestation.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Puerta del Mar
Cadiz, Cádiz, 11010
Almudena Alonso Ojembarrena, MD, +34670234337, almudena.alonso.sspa@juntadeandalucia.es
About this study
Official title: 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.
Read the 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
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- BPD prediction
- Keywords
- Lung ultrasound, NICU, Premature, Proteomics
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPD predictionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: BPD prediction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: After 36 weeks' postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Dec 2020
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andaluz Health Service
- Sponsor type
- Other government
- Collaborators
- University of Cadiz, European Society of Pediatric and Neonatal Intensive Care
- Responsible party
- Principal investigator, Almudena Alonso Ojembarrena, Andaluz Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785859
- Sponsor's protocol ID
- NEO-LUS-20-01
- Acronym
- PARADYS
- Status last verified
- Feb 2023
- First submitted
- 2 Mar 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40368027
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Prediction of the Risk of Moderate-severe Bronchopulmonary Dysplasia in Neonates Born Before 30 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT04785859
- Acronym / sponsor ID
- PARADYS / NEO-LUS-20-01
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Lung ultrasound, NICU, Premature, Proteomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Andaluz Health ServiceOther government
- Collaborators
- University of Cadiz, European Society of Pediatric and Neonatal Intensive Care
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-severe bronchopulmonary dysplasia | – | Diagnostic Test: BPD predictionNeonates 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. |
| no moderate-severe bronchopulmonary dysplasia | – | Diagnostic Test: BPD predictionNeonates 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. |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates born before 30 weeks' gestation.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPD predictionThe 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. | Diagnostic test | Moderate-severe bronchopulmonary dysplasia, no moderate-severe bronchopulmonary dysplasia |
Primary outcome
multiparametric moderate-severe BPD prediction
Time frame: 7 days
• 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.
2 secondary outcomes
respiratory variables prediction by LUS
Time frame: 7 days
Diffusion of the models obtained
Time frame: After 36 weeks' postmenstrual age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 40368027Garrido-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia, run by Andaluz Health Service at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Almudena Alonso-Ojembarrena, MD (+34670234337, almudena.alonso.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
multiparametric moderate-severe BPD prediction (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04785859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.