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.

University Hospital, Caen1 site in 1 country38 target enrollmentDecember 20, 2022

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 20, 2022

End Date

September 1, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•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.

Change in microbiome abundance

Time Frame: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).

Number of reads for a given taxonomy.

Change in microbiome diversity

Time Frame: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).

Shannon diversity index

Virus presence

Time Frame: Day 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.

Occurence of bronchopulmonary dysplasia(At discharge from neonatology.)
Change in expression of local innate immunity markers(Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).)