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

NCT ID: NCT05717283

Last Updated: 2024-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2023-09-01

Brief Summary

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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

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Conditions

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Microbial Colonization Viral Infection Neonatal Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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Nasal swab

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CAEN University Hospital

Caen, , France

Site Status

Countries

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France

Other Identifiers

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2022-A01965-38

Identifier Type: -

Identifier Source: org_study_id

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