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

Primary Purpose

Microbial Colonization, Viral Infection, Neonatal Infection

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Nasal swab

About this trial

This is an interventional basic science trial for Microbial Colonization focused on measuring Metatranscriptomics, Microbiome, Newborn

Eligibility Criteria

undefined - 48 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CAEN University HospitalRecruiting

Outcomes

Primary Outcome Measures

Change in microbiome diversity

Shannon diversity index

Change in microbiome abundance

Number of reads for a given taxonomy.

Virus presence

Molecular detection of respiratory viruses using multiplex PCR.

Secondary Outcome Measures

Occurence of bronchopulmonary dysplasia

assessed by clinical recording on discharge from neonatology

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.

Full Information

NCT ID

NCT05717283

First Posted

January 4, 2023

Last Updated

February 10, 2023

Sponsor

University Hospital, Caen

1. Study Identification

Unique Protocol Identification Number

NCT05717283

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 20, 2022 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Microbial Colonization, Viral Infection, Neonatal Infection

Keywords

Metatranscriptomics, Microbiome, Newborn

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Diagnostic Test

Intervention Name(s)

Nasal swab

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in microbiome diversity

Description

Shannon diversity index

Time Frame

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

Title

Change in microbiome abundance

Description

Number of reads for a given taxonomy.

Time Frame

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

Title

Virus presence

Description

Molecular detection of respiratory viruses using multiplex PCR.

Time Frame

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

Secondary Outcome Measure Information:

Title

Occurence of bronchopulmonary dysplasia

Description

assessed by clinical recording on discharge from neonatology

Time Frame

At discharge from neonatology.

Title

Change in expression of local innate immunity markers

Description

Mesure of the expression of the interferon-stimulated genes (ISGs), anti-viral genes, and the inflammasome pathway.

Time Frame

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

10. Eligibility

Sex

All

Maximum Age & Unit of Time

48 Hours

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amélie Blanchetière

Phone

+33231272564

blanchetiere-a@chu-caen.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Meriadeg Le Gouil

Phone

+33231272554

meriadeg.legouil@unicaen.fr

Facility Information:

Facility Name

CAEN University Hospital

City

Caen

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

LE GOUIL

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Individual participant data will be anonymised.

Learn more about this trial

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

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