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

Newborn; Infection Clinical Trial

— NEONATMICROBIO  

Official 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06389383
• Other study ID #: 22-0182
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 21, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: December 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Newborn; Infection
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
France	CAEN University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of viral infections		from baseline to end of hospitalization (up to 2 months)