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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05717283
Other study ID # 2022-A01965-38
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 20, 2022
Est. completion date September 1, 2023

Study information

Verified date January 2024
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this interventional study is to learn about nasal microbiome and viral infections in newborns hospitalised in neonatology. The main questions it aims to answer are : - how often are newborns infected by viruses in neonatology ? - how does the microbiome develop during first weeks of life ? - how does microbiome and viruses interacts together ? - is there a link between viral infection, microbiome, and medical complications during hospitalisation in neonatology ? Participants will have a nasal swab taken each week during their hospitalisation in neonatology, and researchers will take medical data from the medical chart.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date September 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 48 Hours
Eligibility Inclusion Criteria: - newborn hospitalised in neonatal intensive care unit during the inclusion period - parents have been informed about the study (speaking french) and have signed the informed consent. - affiliated to the social security system. Exclusion Criteria: - parental refusal - minor parents or under judicial protection - newborn who already have been discharded home before inclusion - hospitalisation after the first 48 hours of life - only palliative care

Study Design


Intervention

Diagnostic Test:
Nasal swab
We will take nasal swabs from anterior and middle nostril, once a week for each newborn included.

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 Change in microbiome diversity Shannon diversity index Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Primary Change in microbiome abundance Number of reads for a given taxonomy. Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Primary Virus presence Molecular detection of respiratory viruses using multiplex PCR. Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Secondary Occurence of bronchopulmonary dysplasia assessed by clinical recording on discharge from neonatology At discharge from neonatology.
Secondary Change in expression of local innate immunity markers Mesure of the expression of the interferon-stimulated genes (ISGs), anti-viral genes, and the inflammasome pathway. Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
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