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

NCT06389383 | Completed

• 1 other identifier: 22-0182
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborn; Infection

Outcome Measures

Primary Outcomes (1)

• rate of viral infections

  from baseline to end of hospitalization (up to 2 months)

Study Arms (1)

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

Other: Nasal Swab

Interventions

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

Nasal swab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Refusal of parental consent
• Parents who are minors or under guardianship, curatorship, safeguard of justice or legal protection.
• Hospitalization beyond the first 48 hours of life
• Only palliative care.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CAEN University Hospital

Caen, France

Location

MeSH Terms

Conditions

Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 29, 2024
• Study Start: December 21, 2022
• Primary Completion: June 30, 2023
• Study Completion: November 13, 2024
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

FR (1)