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Not yet recruiting NCT07411261

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

No phase Interventional Bronchopulmonary Dysplasia Preterm Infant Development Asthma Childhood Bronchiolitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nasal swab, blood sampling, Mother milk sampling, Stool sampling.
Who it may be relevant to
Registry conditions: Bronchopulmonary Dysplasia, Preterm Infant Development, Asthma Childhood, Bronchiolitis. Basic parameters: up to 72 Hours · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Diagnosis of bronchopulmonary dysplasia [Time frame: 36 gestational weeks]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

France · 6 centers
  • Service de néonatalogie, CHU d'Amiens — Amiens
  • Service de néonatalogie, CHU de Caen — Caen
  • Service de néonatalogie, CH Cherbourg-en-Cotentin — Cherbourg
  • Service de néonatalogie, GHT du Havre — Le Havre
  • Service de néonatalogie, CHRU de Lille — Lille
  • Service de néonatalogie, CHU de Rouen — Rouen

Identifiers

NCT: NCT07411261 · 25-0197 · 2025-A01723-46

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗