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

• Sponsor: University Hospital, Caen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05717283
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 10.3
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Microbial Colonization; Viral Infection; Neonatal Infection	Diagnostic Test: Nasal swab	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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.
• Actual Study Start Date: Dec 20, 2022
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Outcome Measures

Primary Outcome Measures

1. 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

2. 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.

3. 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

1. Occurence of bronchopulmonary dysplasia [At discharge from neonatology.]

   assessed by clinical recording on discharge from neonatology

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 48 Hours
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CAEN University Hospital	Caen		France

Sponsors and Collaborators

• University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Caen
• ClinicalTrials.gov Identifier: NCT05717283
• Other Study ID Numbers: 2022-A01965-38
• First Posted: Feb 8, 2023
• Last Update Posted: Feb 13, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Caen: Metatranscriptomics; Microbiome; Newborn
• Additional relevant MeSH terms: Infections; Communicable Diseases; Virus Diseases

Study Results

No Results Posted as of Feb 13, 2023