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ClinicalTrials.gov ID

NCT07411261

Lead Sponsor

University Hospital, CaenOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

270Estimated

Last Update Posted

Feb 13, 2026Actual

Start Date

Mar 2026Estimated

Primary Completion Date

Mar 2029Estimated

Completion Date

Mar 2031Estimated

Official Title

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

Brief 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, 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.

• Bronchopulmonary Dysplasia
• Preterm Infant Development
• Asthma Childhood
• Bronchiolitis
• Viral Respiratory Tract Infections

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

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Screening

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, CaenOTHER

Collaborators

INSERM UMR1311 DYNAMICUREUNKNOWN

amelie.blanchetiere@unicaen.fr+33231272564

julien.mourdie@ch-havre.fr02 32 73 41 52

kevin.leduc@chu-lille.fr+33320445962

lucile.tzaroukian@chu-rouen.fr+332 32 88 82 58