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NOT YET RECRUITING
NCT07411261
NA

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

Sponsor: University Hospital, Caen

View on ClinicalTrials.gov

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

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.

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