PremaBiom: Metatranscriptomics of the Respiratory Microbiome to Predict the Occurrence of Bronchopulmonary Dysplasia in Preterm Infants (PremaBiom)

February 11, 2026 updated by: University Hospital, Caen

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80000
      • Caen, France, 14000
      • Cherbourg, France, 50000
      • Le Havre, France, 76600
      • Lille, France, 59000
        • Service de néonatalogie, CHRU de Lille
        • Contact:
      • Rouen, France, 76000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Observational arm
This is a cohort of preterm infants, the interventions provided additionally to standard care are biological sampling (nasal swab, stool, blood and milk).
Biological: Nasal swab
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.
Biological: blood sampling
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).
Biological: Mother milk sampling
For 50-60 patients: 1 mL of mother milk will be sampled once during hospital stay in case of breastfeeding.
Biological: Stool sampling
Stool sampling will occure at birth (within 72 hours after birth), then once a week during neonatal unit stay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 gestational weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multidimensional analysis of microbiome profiles
Time Frame: At birth, 32 GW (gestational weeks), 36 GW and 4 months of corrected age.

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.
At birth, 32 GW (gestational weeks), 36 GW and 4 months of corrected age.
Bronchopulmonary dysplasia severity
Time Frame: 36 gestational weeks
According to the ventilatory support and oxygenation level required at 36 gestational weeks, BPD severity will be defined accordind to Higgings 2018 criteria.
36 gestational weeks
Viral detection
Time Frame: At birth, 32 GW (gestational weeks), 36 GW and 4 months of corrected age.
At each timepoint, metatranscriptomic approach may identify a virus into the nasal swabs.
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.
Parents will answer short questionnaires to assess the occurence of viral respiratory infections or bronchiolitis for their infant after discharge.
1, 2, 4, 8, 12, 18, 24 and 36 months of corrected age.
Preschool asthma
Time Frame: Up to 36 months of corrected age.
The existence of preschool asthma (diagnosed or described by symptoms), will be search at 12, 18, 24, and 36 months by parental questionnaire.
Up to 36 months of corrected age.
Cellular RNA expression in peripherical blood
Time Frame: 36 gestational weeks
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.
36 gestational weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Collaborators

INSERM UMR1311 DYNAMICURE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2031

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-0197
  • 2025-A01723-46 (Registry Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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