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Clinical Trials/NCT06389383
NCT06389383
Completed
Not Applicable

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.

University Hospital, Caen1 site in 1 country38 target enrollmentDecember 21, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Newborn; Infection
Sponsor
University Hospital, Caen
Enrollment
38
Locations
1
Primary Endpoint
rate of viral infections
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 21, 2022
End Date
November 13, 2024
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

rate of viral infections

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

Study Sites (1)

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