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PremaBiom: Metatranscriptomics of the Respiratory Microbiome to Predict the Occurrence of Bronchopulmonary Dysplasia in Preterm Infants
Sponsor: University Hospital, Caen
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.
Key Details
Gender
All
Age Range
Any - 72 Hours
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2026-03
Completion Date
2031-03
Last Updated
2026-02-13
Healthy Volunteers
No
Conditions
Interventions
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.
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).
Mother milk sampling
For 50-60 patients: 1 mL of mother milk will be sampled once during hospital stay in case of breastfeeding.
Stool sampling
Stool sampling will occure at birth (within 72 hours after birth), then once a week during neonatal unit stay.
Locations (6)
Service de néonatalogie, CHU d'Amiens
Amiens, France
Service de néonatalogie, CHU de Caen
Caen, France
Service de néonatalogie, CH Cherbourg-en-Cotentin
Cherbourg, France
Service de néonatalogie, GHT du Havre
Le Havre, France
Service de néonatalogie, CHRU de Lille
Lille, France
Service de néonatalogie, CHU de Rouen
Rouen, France