Pilot Study - Monitoring the Nasal Microbiome and Viral Respiratory Infections in Newborn Hospitalized in Neonatalogy.

NCT ID: NCT06389383

Last Updated: 2025-07-24

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

2022-12-21

Study Completion Date

2024-11-13

Brief Summary

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The objective of our study is therefore to study the evolution of the respiratory microbiome of hospitalized newborns, its interaction with viral infections and their impacts on the evolution of newborns.

Detailed Description

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Conditions

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Newborn; Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Nasal swab

* Nasal swab once a week for the duration of the stay in intensive care unit/intensive care (procedure already carried out routinely to detect nasal staphylococcus once a week).
* Nasal swab every 14 days when the newborn is hospitalized in routine care/kangaroo unit/hospitalization at home

Group Type OTHER

Nasal Swab

Intervention Type OTHER

* Nasal swab once a week for the duration of the stay in intensive care unit/intensive care (procedure already carried out routinely to detect nasal staphylococcus once a week).
* Nasal swab every 14 days when the newborn is hospitalized in routine care/kangaroo unit/hospitalization at home

Interventions

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Nasal Swab

* Nasal swab once a week for the duration of the stay in intensive care unit/intensive care (procedure already carried out routinely to detect nasal staphylococcus once a week).
* Nasal swab every 14 days when the newborn is hospitalized in routine care/kangaroo unit/hospitalization at home

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Newborn hospitalized in intensive care or neonatal intensive care.
* Whose parents were able to be informed of the study and who signed consent.
* Parents affiliate to the social security system

Exclusion Criteria

* Refusal of parental consent
* Parents who are minors or under guardianship, curatorship, safeguard of justice or legal protection.
* Newborn having already left the hospital/returned home before inclusion
* Hospitalization beyond the first 48 hours of life
* Only palliative care.
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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22-0182

Identifier Type: -

Identifier Source: org_study_id

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