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OpenTrials
Completed

NCT Number: NCT06389383

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

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.

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Key information

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 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.

Treatment and study plan

Nasal Swab

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

Primary outcomes

  1. rate of viral infections

    Time frame: from baseline to end of hospitalization (up to 2 months)

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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.

Acronym: NEONATMICROBIO

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 29, 2024
Registry last updated
Jul 24, 2025

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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