Bronchopulmonary Dysplasia (BPD)ELVIRENCT07487259
Impact of the Early Life Virome Development on Bronchopulmonary Dysplasia in Preterm Neonates
An observational study of Bronchopulmonary Dysplasia (BPD), run by Hospices Civils de Lyon.
Trial summary
Bronchopulmonary dysplasia (BPD) is the most frequent respiratory complication in extremely preterm infants. It leads to significant mortality and long-term morbidity. The pathophysiology of BPD is multifactorial, involving inflammation and oxidative stress due to neonatal exposures such as mechanical ventilation and… Read more about this study
- Who is it for?
- Ages Up to 30 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia (BPD)
- What is being tested?
- Viral metagenomics and metatranscriptomics analysis of oropharyngeal and stool samples
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Neonates hospitalised in the neonatal intensive care unit (NICU) of Lyon University Hospital, France.
Who may be able to join
- Birth < 30 SA
- Respiratory support at birth (invasive or non-invasive ventilation, or oxygen supplementation).
Who cannot join
- - Major congenital anomalies of the lung or airways.
- Death, transfer or discharge before 36 weeks' postmenstrual age (PMA) (not allowing progression to BPD to be known).
- Number of respiratory samples collected < 3
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Bronchopulmonary dysplasia (BPD) is the most frequent respiratory complication in extremely preterm infants. It leads to significant mortality and long-term morbidity. The pathophysiology of BPD is multifactorial, involving inflammation and oxidative stress due to neonatal exposures such as mechanical ventilation and infections.
Previous studies have highlighted the role of respiratory bacterial microbiota in BPD development, with causal effects having been demonstrated in murine models. Moreover, the gut-lung axis is implicated in BPD, with alterations to the gut bacteriome and mycobiome observed in preterm infants in the first weeks of life who later develop BPD.
Read more
Despite its critical role in shaping immunity and microbial ecology, the virome has been largely understudied in preterm infants. Our recent observations have revealed the existence of a detectable respiratory virome at birth in most very preterm infants, and certain virome and bacteriome profiles have been found to be associated with different risks of developing BPD.
Hypothesis:
The early acquisition and dynamics of the respiratory and gut virome in the first weeks of life influence microbiome structure and pulmonary immune development, contributing to BPD pathogenesis. These dynamics may define distinct endotypes of BPD with implications for prognosis and therapy.
Objectives:
- Primary: Characterize the evolution of the respiratory and gut virome during the first 3 weeks of life in infants born <30 weeks of gestation, comparing those who develop BPD to those who do not.
- Secondary:
- Define different BPD endotypes and assess their association with demographic and clinical characteristics
- Characterise the structure of the microbiome within each endotype.
- Compare the evolution of the virome, bacteriome and mycobiome within and between anatomical sites.
Study Design:
A monocentric, prospective observational cohort of 40 preterm infants (<30 weeks GA) requiring respiratory support at birth. Infants are classified at 36 weeks' postmenstrual age (PMA) into BPD and non-BPD groups based on oxygen dependency.
Sample Collection:
- Oropharyngeal aspirates: Collected at days 0, 7, 14, and 21.
- Stool samples: Collected at days 7, 14, and 21.
Methods:
- Virome analysis: Viral metagenomics
- Metatranscriptomics: Assess transcriptionally active bacteria/fungi and host gene expression.
- Data integration: Multi-omics factor analysis and unsupervised clustering to identify BPD endotypes; ecological network analysis to evaluate microbiome structure and interactions.
Outcomes:
- Primary: Qualitative and quantitative assessment of virome composition and diversity, including dynamics and persistence across timepoints.
- Secondary: Definition of microbiome-based endotypes; interaction networks between viruses, bacteria, and fungi; and longitudinal comparisons of microbial diversity and composition across anatomical sites.
Read the detailed description
Bronchopulmonary dysplasia (BPD) is the most frequent respiratory complication in extremely preterm infants. It leads to significant mortality and long-term morbidity. The pathophysiology of BPD is multifactorial, involving inflammation and oxidative stress due to neonatal exposures such as mechanical ventilation and infections.
Previous studies have highlighted the role of respiratory bacterial microbiota in BPD development, with causal effects having been demonstrated in murine models. Moreover, the gut-lung axis is implicated in BPD, with alterations to the gut bacteriome and mycobiome observed in preterm infants in the first weeks of life who later develop BPD.
Despite its critical role in shaping immunity and microbial ecology, the virome has been largely understudied in preterm infants. Our recent observations have revealed the existence of a detectable respiratory virome at birth in most very preterm infants, and certain virome and bacteriome profiles have been found to be associated with different risks of developing BPD.
Hypothesis:
The early acquisition and dynamics of the respiratory and gut virome in the first weeks of life influence microbiome structure and pulmonary immune development, contributing to BPD pathogenesis. These dynamics may define distinct endotypes of BPD with implications for prognosis and therapy.
Objectives:
- Primary: Characterize the evolution of the respiratory and gut virome during the first 3 weeks of life in infants born <30 weeks of gestation, comparing those who develop BPD to those who do not.
- Secondary:
- Define different BPD endotypes and assess their association with demographic and clinical characteristics
- Characterise the structure of the microbiome within each endotype.
- Compare the evolution of the virome, bacteriome and mycobiome within and between anatomical sites.
Study Design:
A monocentric, prospective observational cohort of 40 preterm infants (<30 weeks GA) requiring respiratory support at birth. Infants are classified at 36 weeks' postmenstrual age (PMA) into BPD and non-BPD groups based on oxygen dependency.
Sample Collection:
- Oropharyngeal aspirates: Collected at days 0, 7, 14, and 21.
- Stool samples: Collected at days 7, 14, and 21.
Methods:
- Virome analysis: Viral metagenomics
- Metatranscriptomics: Assess transcriptionally active bacteria/fungi and host gene expression.
- Data integration: Multi-omics factor analysis and unsupervised clustering to identify BPD endotypes; ecological network analysis to evaluate microbiome structure and interactions.
Outcomes:
- Primary: Qualitative and quantitative assessment of virome composition and diversity, including dynamics and persistence across timepoints.
- Secondary: Definition of microbiome-based endotypes; interaction networks between viruses, bacteria, and fungi; and longitudinal comparisons of microbial diversity and composition across anatomical sites.
- Conditions
- Bronchopulmonary Dysplasia (BPD)
- Being tested
- Viral metagenomics and metatranscriptomics analysis of oropharyngeal and stool samples
- Keywords
- Bronchopulmonary dysplasia, Microbiome, Virome, Premature neonates
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viral metagenomics and metatranscriptomics analysis of oropharyngeal and stool samplesOther
Viral metagenomics and metatranscriptomics will be performed following standardised protocol (published https://doi.org/10.1186/s12879-018-3446-5 and https://doi.org/10.3389/fmicb.2025.1685035) on oropharyngeal aspirates collected at days 0, 7, 14, and 21 and on stool samples collected at days 7, 14, and 21.
| Study group | Role | What they receive |
|---|---|---|
| BPD group | The BPD group is defined as infants with moderate or severe BPD, evaluated at 36 weeks' postmenstrual age according to oxygen dependence. BPD is moderate when the infant requires O2 supplementation with FiO2 < 30% at 36 weeks' PMA and severe when the infant requires O2 supplementation with FiO2 ≥ 30% and/or positive pressure ventilation. Receives: Other: Viral metagenomics and metatranscriptomics analysis of oropharyngeal and stool samples | |
| Control group | The control group is defined as infants who did not develop BPD (i.e. who were not oxygen-dependent at 36 weeks' postmenstrual age (PMA)). Receives: Other: Viral metagenomics and metatranscriptomics analysis of oropharyngeal and stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative and quantitative variations in the composition and diversity of the oropharyngeal and digestive viromes in DBP and control patients.
Composition is defined as the relative and absolute abundance of viral species, including both prokaryotic (e.g. bacteriophages) and eukaryotic (e.g. Anelloviridae and Herpesviridae) viruses.
Analysis of compositional dynamics is defined by variations in the abundance of each species between samples, as well as by the persistence time of each viral species for each patient. Diversity is defined by richness (the number of species present) and the Shannon index. Diversity analysis is performed on the entire virome and on eukaryotic viruses, temperate bacteriophages and virulent bacteriophages separately. DBP presence is defined as oxygen dependence at 36 weeks PMA.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary Dysplasia (BPD)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487259
- Sponsor's protocol ID
- 25-5465
- Acronym
- ELVIRE
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Early Life Virome Development on Bronchopulmonary Dysplasia in Preterm Neonates
- ClinicalTrials.gov ID
- NCT07487259
- Acronym / sponsor ID
- ELVIRE / 25-5465
- Conditions
- Bronchopulmonary Dysplasia (BPD)
- Keywords
- Bronchopulmonary dysplasia, Microbiome, Virome, Premature neonates
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 23 Mar 2026 (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.
Bronchopulmonary dysplasia (BPD) is the most frequent respiratory complication in extremely preterm infants. It leads to significant mortality and long-term morbidity. The pathophysiology of BPD is multifactorial, involving inflammation and oxidative stress due to neonatal exposures such as mechanical ventilation and infections.
Previous studies have highlighted the role of respiratory bacterial microbiota in BPD development, with causal effects having been demonstrated in murine models. Moreover, the gut-lung axis is implicated in BPD, with alterations to the gut bacteriome and mycobiome observed in preterm infants in the first weeks of life who later develop BPD.
Despite its critical role in shaping immunity and microbial ecology, the virome has been largely understudied in preterm infants. Our recent observations have revealed the existence of a detectable respiratory virome at birth in most very preterm infants, and certain virome and bacteriome profiles have been found to be associated with different risks of developing BPD.
Hypothesis:
The early acquisition and dynamics of the respiratory and gut virome in the first weeks of life influence microbiome structure and pulmonary immune development, contributing to BPD pathogenesis. These dynamics may define distinct endotypes of BPD with implications for prognosis and therapy.
Objectives:
- Primary: Characterize the evolution of the respiratory and gut virome during the first 3 weeks of life in infants born <30 weeks of gestation, comparing those who develop BPD to those who do not.
- Secondary:
- Define different BPD endotypes and assess their association with demographic and clinical characteristics
- Characterise the structure of the microbiome within each endotype.
- Compare the evolution of the virome, bacteriome and mycobiome within and between anatomical sites.
Study Design:
A monocentric, prospective observational cohort of 40 preterm infants (<30 weeks GA) requiring respiratory support at birth. Infants are classified at 36 weeks' postmenstrual age (PMA) into BPD and non-BPD groups based on oxygen dependency.
Sample Collection:
- Oropharyngeal aspirates: Collected at days 0, 7, 14, and 21.
- Stool samples: Collected at days 7, 14, and 21.
Methods:
- Virome analysis: Viral metagenomics
- Metatranscriptomics: Assess transcriptionally active bacteria/fungi and host gene expression.
- Data integration: Multi-omics factor analysis and unsupervised clustering to identify BPD endotypes; ecological network analysis to evaluate microbiome structure and interactions.
Outcomes:
- Primary: Qualitative and quantitative assessment of virome composition and diversity, including dynamics and persistence across timepoints.
- Secondary: Definition of microbiome-based endotypes; interaction networks between viruses, bacteria, and fungi; and longitudinal comparisons of microbial diversity and composition across anatomical sites.
Detailed description
Bronchopulmonary dysplasia (BPD) is the most frequent respiratory complication in extremely preterm infants. It leads to significant mortality and long-term morbidity. The pathophysiology of BPD is multifactorial, involving inflammation and oxidative stress due to neonatal exposures such as mechanical ventilation and infections.
Previous studies have highlighted the role of respiratory bacterial microbiota in BPD development, with causal effects having been demonstrated in murine models. Moreover, the gut-lung axis is implicated in BPD, with alterations to the gut bacteriome and mycobiome observed in preterm infants in the first weeks of life who later develop BPD.
Despite its critical role in shaping immunity and microbial ecology, the virome has been largely understudied in preterm infants. Our recent observations have revealed the existence of a detectable respiratory virome at birth in most very preterm infants, and certain virome and bacteriome profiles have been found to be associated with different risks of developing BPD.
Hypothesis:
The early acquisition and dynamics of the respiratory and gut virome in the first weeks of life influence microbiome structure and pulmonary immune development, contributing to BPD pathogenesis. These dynamics may define distinct endotypes of BPD with implications for prognosis and therapy.
Objectives:
- Primary: Characterize the evolution of the respiratory and gut virome during the first 3 weeks of life in infants born <30 weeks of gestation, comparing those who develop BPD to those who do not.
- Secondary:
- Define different BPD endotypes and assess their association with demographic and clinical characteristics
- Characterise the structure of the microbiome within each endotype.
- Compare the evolution of the virome, bacteriome and mycobiome within and between anatomical sites.
Study Design:
A monocentric, prospective observational cohort of 40 preterm infants (<30 weeks GA) requiring respiratory support at birth. Infants are classified at 36 weeks' postmenstrual age (PMA) into BPD and non-BPD groups based on oxygen dependency.
Sample Collection:
- Oropharyngeal aspirates: Collected at days 0, 7, 14, and 21.
- Stool samples: Collected at days 7, 14, and 21.
Methods:
- Virome analysis: Viral metagenomics
- Metatranscriptomics: Assess transcriptionally active bacteria/fungi and host gene expression.
- Data integration: Multi-omics factor analysis and unsupervised clustering to identify BPD endotypes; ecological network analysis to evaluate microbiome structure and interactions.
Outcomes:
- Primary: Qualitative and quantitative assessment of virome composition and diversity, including dynamics and persistence across timepoints.
- Secondary: Definition of microbiome-based endotypes; interaction networks between viruses, bacteria, and fungi; and longitudinal comparisons of microbial diversity and composition across anatomical sites.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPD group | – | Other: Viral metagenomics and metatranscriptomics analysis of oropharyngeal and stool samplesThe BPD group is defined as infants with moderate or severe BPD, evaluated at 36 weeks' postmenstrual age according to oxygen dependence. BPD is moderate when the infant requires O2 supplementation with FiO2 < 30% at 36 weeks' PMA and severe when the infant requires O2 supplementation with FiO2 ≥ 30% and/or positive pressure ventilation. |
| Control group | – | Other: Viral metagenomics and metatranscriptomics analysis of oropharyngeal and stool samplesThe control group is defined as infants who did not develop BPD (i.e. who were not oxygen-dependent at 36 weeks' postmenstrual age (PMA)). |
Who may qualify
- Ages
- Up to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates hospitalised in the neonatal intensive care unit (NICU) of Lyon University Hospital, France.
Key inclusion criteria (2 listed)
- Birth < 30 SA
- Respiratory support at birth (invasive or non-invasive ventilation, or oxygen supplementation).
Key exclusion criteria (3 listed)
- - Major congenital anomalies of the lung or airways.
- Death, transfer or discharge before 36 weeks' postmenstrual age (PMA) (not allowing progression to BPD to be known).
- Number of respiratory samples collected < 3
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 |
|---|---|---|
| Viral metagenomics and metatranscriptomics analysis of oropharyngeal and stool samplesViral metagenomics and metatranscriptomics will be performed following standardised protocol (published https://doi.org/10.1186/s12879-018-3446-5 and https://doi.org/10.3389/fmicb.2025.1685035) on oropharyngeal aspirates collected at days 0, 7, 14, and 21 and on stool samples collected at days 7, 14, and 21. | Other | BPD group, Control group |
Primary outcome
Qualitative and quantitative variations in the composition and diversity of the oropharyngeal and digestive viromes in DBP and control patients.
Time frame: through study completion, an average of 1 year
Composition is defined as the relative and absolute abundance of viral species, including both prokaryotic (e.g. bacteriophages) and eukaryotic (e.g. Anelloviridae and Herpesviridae) viruses. Analysis of compositional dynamics is defined by variations in the abundance of each species between samples, as well as by the persistence time of each viral species for each patient. Diversity is defined by richness (the number of species present) and the Shannon index. Diversity analysis is performed on the entire virome and on eukaryotic viruses, temperate bacteriophages and virulent bacteriophages separately. DBP presence is defined as oxygen dependence at 36 weeks PMA.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia (BPD), run by Hospices Civils de Lyon.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JOSSET L Pr, MD (04 72 07 10 22 ext. 33, laurence.josset@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative and quantitative variations in the composition and diversity of the oropharyngeal and digestive viromes in DBP and control patients. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2026.