Follow-up of the Nasal Microbiome and Viral Infections in Newborns Hospitalised in Neonatology.

NCT05717283 | Completed

• 1 other identifier: 2022-A01965-38
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Microbial Colonization; Viral Infection; Neonatal Infection

Keywords

Metatranscriptomics; Microbiome; Newborn

Outcome Measures

Primary Outcomes (3)

• 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).

• 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).

• 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 Outcomes (2)

• Occurence of bronchopulmonary dysplasia

  At discharge from neonatology.

• Change in expression of local innate immunity markers

  Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).

Interventions

Nasal swab DIAGNOSTIC_TEST

We will take nasal swabs from anterior and middle nostril, once a week for each newborn included.

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• parents have been informed about the study (speaking french) and have signed the informed consent.
• affiliated to the social security system.

You may not qualify if:

• parental refusal
• minor parents or under judicial protection
• hospitalisation after 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

Communicable Diseases; Virus Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: January 4, 2023
• First Posted: February 8, 2023
• Study Start: December 20, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)