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

Microbial Colonization Clinical Trial

— NEOBIOME  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05717283
• Other study ID #: 2022-A01965-38
• Status: Completed
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: January 2024
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 48 Hours

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization
• Neonatal Infection
• Viral Infection
• Virus Diseases

Intervention

Diagnostic Test:
• Nasal swab
We will take nasal swabs from anterior and middle nostril, once a week for each newborn included.

Locations

Country	Name	City	State
France	CAEN University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in microbiome diversity	Shannon diversity index	Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Primary	Change in microbiome abundance	Number of reads for a given taxonomy.	Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Primary	Virus presence	Molecular detection of respiratory viruses using multiplex PCR.	Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Secondary	Occurence of bronchopulmonary dysplasia	assessed by clinical recording on discharge from neonatology	At discharge from neonatology.
Secondary	Change in expression of local innate immunity markers	Mesure of the expression of the interferon-stimulated genes (ISGs), anti-viral genes, and the inflammasome pathway.	Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).