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Completed

NCT Number: NCT05717283

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

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.

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Key information

Conditions

Microbial Colonization Communicable Diseases Disease Attributes Infections Neonatal Infection Pathologic Processes Pathological Conditions, Signs and Symptoms Viral Infection Virus Diseases

Age range

Up to 48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CAEN University Hospital

Caen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nasal swab

Diagnostic Test

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

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. Occurence of bronchopulmonary dysplasia

    Time frame: At discharge from neonatology.

    assessed by clinical recording on discharge from neonatology

  2. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study 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.

Acronym: NEOBIOME

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2023
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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