Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:20 AM
Study NCT ID:
NCT07411261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PremaBiom: Metatranscriptomics of the Respiratory Microbiome to Predict the Occurrence of Bronchopulmonary Dysplasia in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D064806', 'term': 'Dysbiosis'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2031-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of bronchopulmonary dysplasia', 'timeFrame': '36 gestational weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Multidimensional analysis of microbiome profiles', 'timeFrame': 'At birth, 32 GW (gestational weeks), 36 GW and 4 months of corrected age.', 'description': '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.\n\nAlso the RNA host expression in particular inate immunity, metabolic and inflammatory pathways.'}, {'measure': 'Bronchopulmonary dysplasia severity', 'timeFrame': '36 gestational weeks', 'description': 'According to the ventilatory support and oxygenation level required at 36 gestational weeks, BPD severity will be defined accordind to Higgings 2018 criteria.'}, {'measure': 'Viral detection', 'timeFrame': 'At birth, 32 GW (gestational weeks), 36 GW and 4 months of corrected age.', 'description': 'At each timepoint, metatranscriptomic approach may identify a virus into the nasal swabs.'}, {'measure': 'Viral infections or bronchiolitis during childhood', 'timeFrame': '1, 2, 4, 8, 12, 18, 24 and 36 months of corrected age.', 'description': 'Parents will answer short questionnaires to assess the occurence of viral respiratory infections or bronchiolitis for their infant after discharge.'}, {'measure': 'Preschool asthma', 'timeFrame': 'Up to 36 months of corrected age.', 'description': 'The existence of preschool asthma (diagnosed or described by symptoms), will be search at 12, 18, 24, and 36 months by parental questionnaire.'}, {'measure': 'Cellular RNA expression in peripherical blood', 'timeFrame': '36 gestational weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respiratory microbiome', 'bronchopulmonary dysplasia', 'Prematurity', 'asthma', 'bronchiolitis', 'inflammation', 'inate immunity', 'respiratory tract infections', 'dysbiosis', 'personalized medicine', 'metatranscriptomics'], 'conditions': ['Bronchopulmonary Dysplasia', 'Preterm Infant Development', 'Asthma Childhood', 'Bronchiolitis', 'Viral Respiratory Tract Infections']}, 'descriptionModule': {'briefSummary': '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:\n\n* What is the role of microbiome maturation in respiratory health (development of bronchopulmonary dysplasia, childhood asthma and viral respiratory infections) of preterm infants ?\n* Which environmental or health factors are involved in the maturation of the respiratory microbiome ?\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '72 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants with gestational age at birth lower than 32 gestational weeks and 6 days.\n* Hospital stay in one of the participant neonatal care units\n* Infants covered by the social security system of at least one of their parents\n* Whose parents have been informed about the study and agree to sign the informed consent form\n\nExclusion Criteria:\n\n* Palliative care only\n* Lack of parental consent\n* Parents who are minors or under legal protection (guardianship, conservatorship, judicial protection)\n* Parents who do not speak French'}, 'identificationModule': {'nctId': 'NCT07411261', 'acronym': 'PremaBiom', 'briefTitle': 'PremaBiom: Metatranscriptomics of the Respiratory Microbiome to Predict the Occurrence of Bronchopulmonary Dysplasia in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'PremaBiom: Metatranscriptomics of the Respiratory Microbiome to Predict the Occurrence of Bronchopulmonary Dysplasia in Preterm Infants', 'orgStudyIdInfo': {'id': '25-0197'}, 'secondaryIdInfos': [{'id': '2025-A01723-46', 'type': 'REGISTRY', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Observational arm', 'description': 'This is a cohort of preterm infants, the interventions provided additionally to standard care are biological sampling (nasal swab, stool, blood and milk).', 'interventionNames': ['Biological: Nasal swab', 'Biological: blood sampling', 'Biological: Mother milk sampling', 'Biological: Stool sampling']}], 'interventions': [{'name': 'Nasal swab', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['Observational arm']}, {'name': 'blood sampling', 'type': 'BIOLOGICAL', 'description': '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).', 'armGroupLabels': ['Observational arm']}, {'name': 'Mother milk sampling', 'type': 'BIOLOGICAL', 'description': 'For 50-60 patients: 1 mL of mother milk will be sampled once during hospital stay in case of breastfeeding.', 'armGroupLabels': ['Observational arm']}, {'name': 'Stool sampling', 'type': 'BIOLOGICAL', 'description': 'Stool sampling will occure at birth (within 72 hours after birth), then once a week during neonatal unit stay.', 'armGroupLabels': ['Observational arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'country': 'France', 'contacts': [{'name': 'Ghida Ghostine', 'role': 'CONTACT', 'email': 'ghostine.ghida@chu-amiens.fr', 'phone': '+333 22 08 76 05'}], 'facility': "Service de néonatalogie, CHU d'Amiens", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '14000', 'city': 'Caen', 'country': 'France', 'contacts': [{'name': 'Amélie Blanchetière', 'role': 'CONTACT', 'email': 'amelie.blanchetiere@unicaen.fr', 'phone': '+33231272564'}], 'facility': 'Service de néonatalogie, CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '50000', 'city': 'Cherbourg', 'country': 'France', 'contacts': [{'name': 'Anne-Sophie Pages', 'role': 'CONTACT', 'email': 'annesophie.pages@ch-cotentin.fr', 'phone': '+332 33 20 76 66'}], 'facility': 'Service de néonatalogie, CH Cherbourg-en-Cotentin', 'geoPoint': {'lat': 49.63984, 'lon': -1.61636}}, {'zip': '76600', 'city': 'Le Havre', 'country': 'France', 'contacts': [{'name': 'Julien Mourdie', 'role': 'CONTACT', 'email': 'julien.mourdie@ch-havre.fr', 'phone': '02 32 73 41 52'}], 'facility': 'Service de néonatalogie, GHT du Havre', 'geoPoint': {'lat': 49.49346, 'lon': 0.10785}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'contacts': [{'name': 'Kevin Le Duc', 'role': 'CONTACT', 'email': 'kevin.leduc@chu-lille.fr', 'phone': '+33320445962'}], 'facility': 'Service de néonatalogie, CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'contacts': [{'name': 'Lucile Tzaroukian', 'role': 'CONTACT', 'email': 'lucile.tzaroukian@chu-rouen.fr', 'phone': '+332 32 88 82 58'}], 'facility': 'Service de néonatalogie, CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Amélie Blanchetière', 'role': 'CONTACT', 'email': 'amelie.blanchetiere@unicaen.fr', 'phone': '+33231272564'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'collaborators': [{'name': 'INSERM UMR1311 DYNAMICURE', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}