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.
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
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
Single group
Nasal swab
Biological/VaccineNasal 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/VaccineFor 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/VaccineFor 50-60 patients: 1 mL of mother milk will be sampled once during hospital stay in case of breastfeeding.
Stool sampling
Biological/VaccineStool 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.
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.
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.
Viral detection
At each timepoint, metatranscriptomic approach may identify a virus into the nasal swabs.
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.
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University Hospital, Caen
Lead sponsor
INSERM UMR1311 DYNAMICURE
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
