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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01723-46 | Registry Identifier | ID-RCB |
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| Name | Class |
|---|---|
| INSERM UMR1311 DYNAMICURE | UNKNOWN |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Multidimensional analysis of microbiome profiles | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amélie Blanchetière | Contact | +33231272564 | amelie.blanchetiere@unicaen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de néonatalogie, CHU d'Amiens | Amiens | 80000 | France |
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| 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). |
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| Mother milk sampling | Biological | For 50-60 patients: 1 mL of mother milk will be sampled once during hospital stay in case of breastfeeding. |
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| Stool sampling | Biological | Stool sampling will occure at birth (within 72 hours after birth), then once a week during neonatal unit stay. |
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| At birth, 32 GW (gestational weeks), 36 GW and 4 months of corrected age. |
| Bronchopulmonary dysplasia severity | According to the ventilatory support and oxygenation level required at 36 gestational weeks, BPD severity will be defined accordind to Higgings 2018 criteria. | 36 gestational weeks |
| Viral detection | At each timepoint, metatranscriptomic approach may identify a virus into the nasal swabs. | At birth, 32 GW (gestational weeks), 36 GW and 4 months of corrected age. |
| Viral infections or bronchiolitis during childhood | Parents will answer short questionnaires to assess the occurence of viral respiratory infections or bronchiolitis for their infant after discharge. | 1, 2, 4, 8, 12, 18, 24 and 36 months of corrected age. |
| Preschool asthma | The existence of preschool asthma (diagnosed or described by symptoms), will be search at 12, 18, 24, and 36 months by parental questionnaire. | Up to 36 months of corrected age. |
| Cellular RNA expression in peripherical blood | 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. | 36 gestational weeks |
| Service de néonatalogie, CHU de Caen | Caen | 14000 | France |
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| Service de néonatalogie, CH Cherbourg-en-Cotentin | Cherbourg | 50000 | France |
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| Service de néonatalogie, GHT du Havre | Le Havre | 76600 | France |
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| Service de néonatalogie, CHRU de Lille | Lille | 59000 | France |
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| Service de néonatalogie, CHU de Rouen | Rouen | 76000 | France |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D001988 | Bronchiolitis |
| D047928 | Premature Birth |
| D001249 | Asthma |
| D007249 | Inflammation |
| D012141 | Respiratory Tract Infections |
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001991 | Bronchitis |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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