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

Not Applicable

Completed

• Conditions: Microbial Colonization; Viral Infection; Neonatal Infection

• Registration Number: NCT05717283
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-20
• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-08
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in microbiome abundance	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	Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).	Shannon diversity index
Virus presence	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.

Secondary Outcome Measures

Name	Time	Method
Occurence of bronchopulmonary dysplasia	At discharge from neonatology.	assessed by clinical recording on 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).	Mesure of the expression of the interferon-stimulated genes (ISGs), anti-viral genes, and the inflammasome pathway.

Trial Locations

Locations (1)

CAEN University Hospital; 🇫🇷 Caen, France