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

NCT07411261 | Not Yet Recruiting

• 2 other identifiers: 25-01972025-A01723-46
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Keywords

respiratory microbiome; bronchopulmonary dysplasia; Prematurity; asthma; bronchiolitis; inflammation; inate immunity; respiratory tract infections; dysbiosis; personalized medicine; metatranscriptomics

Outcome Measures

Primary Outcomes (1)

• Diagnosis of bronchopulmonary dysplasia

  At 36 gestational weeks, bronchopulmonary dysplasia (BPD) will be retained if any ventilatory support (invasive, non invasive, high or low flow oxygen) is required at least 23h over 24. This definition is based on the Jobe 2001 criteria for BPD diagnosis moderate or severe.

  36 gestational weeks

Secondary Outcomes (6)

• Multidimensional analysis of microbiome profiles

  At birth, 32 GW (gestational weeks), 36 GW and 4 months of corrected age.

• Bronchopulmonary dysplasia severity

  36 gestational weeks

• Viral detection

  At birth, 32 GW (gestational weeks), 36 GW and 4 months of corrected age.

• Viral infections or bronchiolitis during childhood

  1, 2, 4, 8, 12, 18, 24 and 36 months of corrected age.

• Preschool asthma

  Up to 36 months of corrected age.

Study Arms (1)

Observational arm

OTHER

This is a cohort of preterm infants, the interventions provided additionally to standard care are biological sampling (nasal swab, stool, blood and milk).

Biological: Nasal swab; Biological: blood sampling; Biological: Mother milk sampling; Biological: Stool sampling

Interventions

Nasal swab BIOLOGICAL

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.

Observational arm

blood sampling BIOLOGICAL

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).

Observational arm

Mother milk sampling BIOLOGICAL

For 50-60 patients: 1 mL of mother milk will be sampled once during hospital stay in case of breastfeeding.

Observational arm

Stool sampling BIOLOGICAL

Stool sampling will occure at birth (within 72 hours after birth), then once a week during neonatal unit stay.

Observational arm

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead
• INSERM UMR1311 DYNAMICURE: collaborator

Study Sites (6)

Service de néonatalogie, CHU d'Amiens

Amiens, 80000, France

Location

Service de néonatalogie, CHU de Caen

Caen, 14000, France

Location

Service de néonatalogie, CH Cherbourg-en-Cotentin

Cherbourg, 50000, France

Location

Service de néonatalogie, GHT du Havre

Le Havre, 76600, France

Location

Service de néonatalogie, CHRU de Lille

Lille, 59000, France

Location

Service de néonatalogie, CHU de Rouen

Rouen, 76000, France

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Bronchiolitis; Premature Birth; Asthma; Inflammation; Respiratory Tract Infections; Dysbiosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bronchitis; Infections; Bronchial Diseases; Lung Diseases, Obstructive; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Amélie Blanchetière

CONTACT

+33231272564; amelie.blanchetiere@unicaen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2031
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

FR (6)