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Follow-up of the Nasal Microbiome and Viral Infections in Newborns Hospitalised in Neonatology.

Follow-up of the Nasal Microbiome and Viral Infections in Newborns Hospitalised in Neonatology in the University Hospital of Caen, France : Metatranscriptomics Approach by Next Generation Sequencing From Nasal Swabs.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05717283
Acronym
NEOBIOME
Enrollment
38
Registered
2023-02-08
Start date
2022-12-20
Completion date
2023-09-01
Last updated
2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbial Colonization, Neonatal Infection, Viral Infection

Keywords

Metatranscriptomics, Microbiome, Newborn

Brief summary

The goal of this interventional study is to learn about nasal microbiome and viral infections in newborns hospitalised in neonatology. The main questions it aims to answer are : * how often are newborns infected by viruses in neonatology ? * how does the microbiome develop during first weeks of life ? * how does microbiome and viruses interacts together ? * is there a link between viral infection, microbiome, and medical complications during hospitalisation in neonatology ? Participants will have a nasal swab taken each week during their hospitalisation in neonatology, and researchers will take medical data from the medical chart.

Interventions

DIAGNOSTIC_TESTNasal swab

We will take nasal swabs from anterior and middle nostril, once a week for each newborn included.

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 48 Hours
Healthy volunteers
No

Inclusion criteria

* newborn hospitalised in neonatal intensive care unit during the inclusion period * parents have been informed about the study (speaking french) and have signed the informed consent. * affiliated to the social security system.

Exclusion criteria

* parental refusal * minor parents or under judicial protection * newborn who already have been discharded home before inclusion * hospitalisation after the first 48 hours of life * only palliative care

Design outcomes

Primary

MeasureTime frameDescription
Change in microbiome diversityDay 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).Shannon diversity index
Change in microbiome abundanceDay 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).Number of reads for a given taxonomy.
Virus presenceDay 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).Molecular detection of respiratory viruses using multiplex PCR.

Secondary

MeasureTime frameDescription
Occurence of bronchopulmonary dysplasiaAt discharge from neonatology.assessed by clinical recording on discharge from neonatology
Change in expression of local innate immunity markersDay 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).Mesure of the expression of the interferon-stimulated genes (ISGs), anti-viral genes, and the inflammasome pathway.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026