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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 72
SponsorUniversity Hospital, Caen

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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 design

Treatments tested in this trial

  • Nasal swab
  • blood sampling
  • Mother milk sampling
  • Stool sampling

Treatment groups

270 Participants
are divided into 1 treatment group

Sponsors and collaborators

University Hospital, Caen

Lead sponsor

INSERM UMR1311 DYNAMICURE

Collaborator