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NCT Number: NCT07411261

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

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.

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Key information

Conditions

Bronchopulmonary Dysplasia Asthma Asthma Childhood Bronchial Diseases Bronchiolitis Bronchitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dysbiosis Female Urogenital Diseases and Pregnancy Complications Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Infections Inflammation Lung Diseases Lung Diseases, Obstructive Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Preterm Infant Development Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Ventilator-Induced Lung Injury Viral Respiratory Tract Infections

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de néonatalogie, CHU d'Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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).

Mother milk sampling

Biological

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

Stool sampling

Biological

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

Primary outcomes

  1. Diagnosis of bronchopulmonary dysplasia

    Time frame: 36 gestational weeks

    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.

Secondary outcomes

  1. Multidimensional analysis of microbiome profiles

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

    From metatranscriptomics analysis of nasal swabs, the following informations will be computed: most abundant species, diversity indexes, clustering, relative abundance of pathobionts, expressed functions, metabolic pathways activated, principal component analysis, linear differencial analysis and effect size.

    Also the RNA host expression in particular inate immunity, metabolic and inflammatory pathways.

  2. Bronchopulmonary dysplasia severity

    Time frame: 36 gestational weeks

    According to the ventilatory support and oxygenation level required at 36 gestational weeks, BPD severity will be defined accordind to Higgings 2018 criteria.

  3. Viral detection

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

    At each timepoint, metatranscriptomic approach may identify a virus into the nasal swabs.

  4. Viral infections or bronchiolitis during childhood

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

    Parents will answer short questionnaires to assess the occurence of viral respiratory infections or bronchiolitis for their infant after discharge.

  5. Preschool asthma

    Time frame: Up to 36 months of corrected age.

    The existence of preschool asthma (diagnosed or described by symptoms), will be search at 12, 18, 24, and 36 months by parental questionnaire.

  6. Cellular RNA expression in peripherical blood

    Time frame: 36 gestational weeks

    For a subgroup of 50-60 patients, single cell RNA sequencing of peripherical blood mononuclear cells will be performed to assess the immune / inflammatory status of patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Amélie Blanchetière

CONTACT

[email protected]

+33231272564

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • INSERM UMR1311 DYNAMICURE

Registry information

Acronym: PremaBiom

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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