An interventional study of Nasal swab and blood sampling in Bronchopulmonary Dysplasia, Preterm Infant Development and Asthma Childhood, sponsored by University Hospital, Caen. Not yet recruiting at 6 sites in France. Open to participants aged Up to 72 Hours. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by University Hospital, Caen · Not applicable, Interventional, and Screening
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.
362 studies on the registry are indexed under Bronchopulmonary Dysplasia; 85 are open to participants now.
This study's planned enrollment of 270 is above the median of 66 across 244 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →University Hospital, Caen is the lead sponsor of 512 studies on the registry; 82 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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).
For 50-60 patients: 1 mL of mother milk will be sampled once during hospital stay in case of breastfeeding.
Stool sampling will occure at birth (within 72 hours after birth), then once a week during neonatal unit stay.
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.
Time frame: 36 gestational weeks
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.
Time frame: 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.
Time frame: 36 gestational weeks
Viral detection
At each timepoint, metatranscriptomic approach may identify a virus into the nasal swabs.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 36 gestational weeks
Start is estimated for Mar 2026; primary completion for Mar 2029, 36 months later.
Of 71 non-industry interventional studies with no phase under Bronchopulmonary Dysplasia, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 56. This study's planned 36 months is above that.
Counting every sponsor, half of 73 studies reached it within 37 months; a quarter within 19 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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