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CompletedNCT06389383NEONATMICROBIOUpdated Jul 24, 2025

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

An interventional study of Nasal Swab in Newborn; Infection, sponsored by University Hospital, Caen. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2025-07-24.

Sponsored by University Hospital, Caen · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Dec 2022, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • Newborn; Infection

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03

In context

Infections

6,686 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 38 is below the median of 120 across 4,199 interventional studies indexed under Infections.

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Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • 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

Interventions

  • OtherNasal 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

06

What researchers measure

Primary outcomes

  1. rate of viral infections

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

07

Study locations

1 site
  • CAEN University Hospital
    Caen, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06389383
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Apr 29, 2024
Start date
Dec 21, 2022
Primary completion
Jun 30, 2023
Completion
Nov 13, 2024
Last update
Jul 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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