NCT07411261

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 72 Hours
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-03-01
• Completion: 2031-03-01
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

6 sites across 1 country: France