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

NCT07411261 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2026-02-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • INSERM UMR1311 DYNAMICURE

    collaborator UNKNOWN

  • University Hospital, Caen

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2029-03-31
Completion
2031-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07411261 on ClinicalTrials.gov