Bronchopulmonary DysplasiaPremaBiomNCT07411261
PremaBiom: Metatranscriptomics of the Respiratory Microbiome to Predict the Occurrence of Bronchopulmonary Dysplasia in Preterm Infants
A study testing Nasal swab, blood sampling and Mother milk sampling in people with Bronchopulmonary Dysplasia and Preterm Infant Development, run by University Hospital, Caen at 6 sites in France.
Trial summary
The goal of this clinical trial is to understand the impact of respiratory microbiome maturation in respiratory health of preterm infants under 32 gestational weeks. The main questions it aims to answer are: What is the role of microbiome maturation in respiratory health (development of bronchopulmonary dysplasia… Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Bronchopulmonary Dysplasia, Preterm Infant Development, Asthma Childhood
- What is being tested?
- Nasal swab, blood sampling and Mother milk sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 6 sitesFrance
- Study dates
- Mar 2026to Mar 2031
- Phase
- Interventional
- 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 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants with gestational age at birth lower than 32 gestational weeks and 6 days.
- Hospital stay in one of the participant neonatal care units
- Infants covered by the social security system of at least one of their parents
- Whose parents have been informed about the study and agree to sign the informed consent form
Who cannot join
- Palliative care only
- Lack of parental consent
- Parents who are minors or under legal protection (guardianship, conservatorship, judicial protection)
- Parents who do not speak French
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites
Service de néonatalogie, CHU d'Amiens
Amiens, 80000
Ghida Ghostine, +333 22 08 76 05, ghostine.ghida@chu-amiens.fr
Service de néonatalogie, CHU de Caen
Caen, 14000
Amélie Blanchetière, +33231272564, amelie.blanchetiere@unicaen.fr
Service de néonatalogie, CH Cherbourg-en-Cotentin
Cherbourg, 50000
Anne-Sophie Pages, +332 33 20 76 66, annesophie.pages@ch-cotentin.fr
Service de néonatalogie, GHT du Havre
Le Havre, 76600
Julien Mourdie, 02 32 73 41 52, julien.mourdie@ch-havre.fr
Service de néonatalogie, CHRU de Lille
Lille, 59000
Kevin Le Duc, +33320445962, kevin.leduc@chu-lille.fr
Service de néonatalogie, CHU de Rouen
Rouen, 76000
Lucile Tzaroukian, +332 32 88 82 58, lucile.tzaroukian@chu-rouen.fr
About this study
The goal of this clinical trial is to understand the impact of respiratory microbiome maturation in respiratory health of preterm infants under 32 gestational weeks. The main questions it aims to answer are:
- What is the role of microbiome maturation in respiratory health (development of bronchopulmonary dysplasia, childhood asthma and viral respiratory infections) of preterm infants ?
- Which environmental or health factors are involved in the maturation of the respiratory microbiome ?
Participants will undergo follow-up from birth until 3 years of corrected age including nasal swabs, stool samples, and for some of them blood and milk sample.
- Conditions
- Bronchopulmonary Dysplasia, Preterm Infant Development, Asthma Childhood, Bronchiolitis, Viral Respiratory Tract Infections
- Being tested
- Nasal swab, blood sampling, Mother milk sampling, Stool sampling
- Keywords
- respiratory microbiome, bronchopulmonary dysplasia, Prematurity, asthma, bronchiolitis, inflammation, inate immunity, respiratory tract infections, dysbiosis, personalized medicine, metatranscriptomics
- Medical subject headings
- Bronchopulmonary Dysplasia, Bronchiolitis, Premature Birth, Asthma, Inflammation, Respiratory Tract Infections, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal swabBiological
Nasal swab is performed by nurses at birth (within 72 hours), and each week during initial neonatal care unit stay. After discharge, nasal swabs will be performed by parents at home and sent by post to the investigational center.
blood samplingBiological
For 50-60 patients: 1 mL of blood sampling will be performed once during current care blood test (without additional blood draw), around 36 gestational weeks (+/- 1 week).
Mother milk samplingBiological
For 50-60 patients: 1 mL of mother milk will be sampled once during hospital stay in case of breastfeeding.
Stool samplingBiological
Stool sampling will occure at birth (within 72 hours after birth), then once a week during neonatal unit stay.
| Study group | Role | What they receive |
|---|---|---|
| Observational arm | Other | This is a cohort of preterm infants, the interventions provided additionally to standard care are biological sampling (nasal swab, stool, blood and milk). Receives: Biological: Nasal swab; Biological: blood sampling; Biological: Mother milk sampling; Biological: Stool sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of bronchopulmonary dysplasia
At 36 gestational weeks, bronchopulmonary dysplasia (BPD) will be retained if any ventilatory support (invasive, non invasive, high or low flow oxygen) is required at least 23h over 24. This definition is based on the Jobe 2001 criteria for BPD diagnosis moderate or severe.
Measured: 36 gestational weeks
Secondary outcomes (6)
Multidimensional analysis of microbiome profiles
From metatranscriptomics analysis of nasal swabs, the following informations will be computed: most abundant species, diversity indexes, clustering, relative abundance of pathobionts, expressed functions, metabolic pathways activated, principal component analysis, linear differencial analysis and effect size.
Also the RNA host expression in particular inate immunity, metabolic and inflammatory pathways.
Measured: At birth, 32 GW (gestational weeks), 36 GW and 4 months of corrected age.
Bronchopulmonary dysplasia severity
According to the ventilatory support and oxygenation level required at 36 gestational weeks, BPD severity will be defined accordind to Higgings 2018 criteria.
Measured: 36 gestational weeks
Viral detection
At each timepoint, metatranscriptomic approach may identify a virus into the nasal swabs.
Measured: At birth, 32 GW (gestational weeks), 36 GW and 4 months of corrected age.
Viral infections or bronchiolitis during childhood
Parents will answer short questionnaires to assess the occurence of viral respiratory infections or bronchiolitis for their infant after discharge.
Measured: 1, 2, 4, 8, 12, 18, 24 and 36 months of corrected age.
Preschool asthma
The existence of preschool asthma (diagnosed or described by symptoms), will be search at 12, 18, 24, and 36 months by parental questionnaire.
Measured: Up to 36 months of corrected age.
Cellular RNA expression in peripherical blood
For a subgroup of 50-60 patients, single cell RNA sequencing of peripherical blood mononuclear cells will be performed to assess the immune / inflammatory status of patients.
Measured: 36 gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM UMR1311 DYNAMICURE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411261
- Sponsor's protocol ID
- 25-0197
- Other IDs
- 2025-A01723-46
- Acronym
- PremaBiom
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PremaBiom: Metatranscriptomics of the Respiratory Microbiome to Predict the Occurrence of Bronchopulmonary Dysplasia in Preterm Infants
- ClinicalTrials.gov ID
- NCT07411261
- Acronym / sponsor ID
- PremaBiom / 25-0197
- Conditions
- Bronchopulmonary Dysplasia, Preterm Infant Development, Asthma Childhood, Bronchiolitis, Viral Respiratory Tract Infections
- Keywords
- respiratory microbiome, bronchopulmonary dysplasia, Prematurity, asthma, bronchiolitis, inflammation, inate immunity, respiratory tract infections
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- INSERM UMR1311 DYNAMICURE
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 13 Feb 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.
The goal of this clinical trial is to understand the impact of respiratory microbiome maturation in respiratory health of preterm infants under 32 gestational weeks. The main questions it aims to answer are:
- What is the role of microbiome maturation in respiratory health (development of bronchopulmonary dysplasia, childhood asthma and viral respiratory infections) of preterm infants ?
- Which environmental or health factors are involved in the maturation of the respiratory microbiome ?
Participants will undergo follow-up from birth until 3 years of corrected age including nasal swabs, stool samples, and for some of them blood and milk sample.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational arm | Other | Biological: Nasal swab, Biological: blood sampling, Biological: Mother milk sampling, Biological: Stool samplingThis is a cohort of preterm infants, the interventions provided additionally to standard care are biological sampling (nasal swab, stool, blood and milk). |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm infants with gestational age at birth lower than 32 gestational weeks and 6 days.
- Hospital stay in one of the participant neonatal care units
- Infants covered by the social security system of at least one of their parents
- Whose parents have been informed about the study and agree to sign the informed consent form
Key exclusion criteria (4 listed)
- Palliative care only
- Lack of parental consent
- Parents who are minors or under legal protection (guardianship, conservatorship, judicial protection)
- Parents who do not speak French
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 |
|---|---|---|
| Nasal swabNasal swab is performed by nurses at birth (within 72 hours), and each week during initial neonatal care unit stay. After discharge, nasal swabs will be performed by parents at home and sent by post to the investigational center. | Biological | Observational arm |
| blood samplingFor 50-60 patients: 1 mL of blood sampling will be performed once during current care blood test (without additional blood draw), around 36 gestational weeks (+/- 1 week). | Biological | Observational arm |
| Mother milk samplingFor 50-60 patients: 1 mL of mother milk will be sampled once during hospital stay in case of breastfeeding. | Biological | Observational arm |
| Stool samplingStool sampling will occure at birth (within 72 hours after birth), then once a week during neonatal unit stay. | Biological | Observational arm |
Primary outcome
Diagnosis of bronchopulmonary dysplasia
Time frame: 36 gestational weeks
At 36 gestational weeks, bronchopulmonary dysplasia (BPD) will be retained if any ventilatory support (invasive, non invasive, high or low flow oxygen) is required at least 23h over 24. This definition is based on the Jobe 2001 criteria for BPD diagnosis moderate or severe.
6 secondary outcomes
Multidimensional analysis of microbiome profiles
Time frame: At birth, 32 GW (gestational weeks), 36 GW and 4 months of corrected age.
Bronchopulmonary dysplasia severity
Time frame: 36 gestational weeks
Viral detection
Time frame: At birth, 32 GW (gestational weeks), 36 GW and 4 months of corrected age.
Viral infections or bronchiolitis during childhood
Time frame: 1, 2, 4, 8, 12, 18, 24 and 36 months of corrected age.
Preschool asthma
Time frame: Up to 36 months of corrected age.
Cellular RNA expression in peripherical blood
Time frame: 36 gestational weeks
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 13 Feb 2026.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal swab, blood sampling and Mother milk sampling in people with Bronchopulmonary Dysplasia and Preterm Infant Development, run by University Hospital, Caen at 6 sites in France.
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 4 inclusion and 4 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 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
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 Amélie Blanchetière (+33231272564, amelie.blanchetiere@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of bronchopulmonary dysplasia (time frame: 36 gestational weeks). 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 13 Feb 2026.