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

February 12, 2024 updated by: University Hospital, Caen

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.

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.

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

No older than 2 days (Child)

Accepts Healthy Volunteers

No

Description

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

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in microbiome diversity
Time Frame: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Shannon diversity index
Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Change in microbiome abundance
Time Frame: 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.
Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Virus presence
Time Frame: 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.
Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of bronchopulmonary dysplasia
Time Frame: At discharge from neonatology.
assessed by clinical recording on discharge from neonatology
At discharge from neonatology.
Change in expression of local innate immunity markers
Time Frame: 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.
Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).

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 20, 2022

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

February 3, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A01965-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will be anonymised.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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