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

July 21, 2025 updated by: University Hospital, Caen

Pilot Study - Monitoring the Nasal Microbiome and Viral Respiratory Infections in Newborn Hospitalized in Neonatalogy. Metatranscriptomic Approach by New Generation Sequencing From High Respiratory Swabs.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France
        • Caen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of viral infections
Time Frame: from baseline to end of hospitalization (up to 2 months)
from baseline to end of hospitalization (up to 2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

November 13, 2024

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2025

Last Update Submitted That Met QC Criteria

July 21, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-0182

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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