Microbial ColonizationNEOBIOMENCT05717283
Follow-up of the Nasal Microbiome and Viral Infections in Newborns Hospitalised in Neonatology.
A study testing Nasal swab in people with Microbial Colonization and Viral Infection, run by University Hospital, Caen at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Microbial Colonization, Viral Infection, Neonatal Infection
- What is being tested?
- Nasal swab
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up of the Nasal Microbiome and Viral Infections in Newborns Hospitalised in Neonatology in the University Hospital of Caen, France : Metatranscriptomics Approach by Next Generation Sequencing From Nasal Swabs.
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
- Being tested
- Nasal swab
- Keywords
- Metatranscriptomics, Microbiome, Newborn
- Medical subject headings
- Communicable Diseases, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal swabDiagnostic test
We will take nasal swabs from anterior and middle nostril, once a week for each newborn included.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microbiome diversity
Shannon diversity index
Measured: 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.
Measured: 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.
Measured: 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
assessed by clinical recording on discharge from neonatology
Measured: At discharge from neonatology.
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.
Measured: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start20 Dec 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717283
- Sponsor's protocol ID
- 2022-A01965-38
- Acronym
- NEOBIOME
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be anonymised.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of the Nasal Microbiome and Viral Infections in Newborns Hospitalised in Neonatology in the University Hospital of Caen, France : Metatranscriptomics Approach by Next Generation Sequencing From Nasal Swabs.
- ClinicalTrials.gov ID
- NCT05717283
- Acronym / sponsor ID
- NEOBIOME / 2022-A01965-38
- Conditions
- Microbial Colonization, Viral Infection, Neonatal Infection
- Keywords
- Metatranscriptomics, Microbiome, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal swabWe will take nasal swabs from anterior and middle nostril, once a week for each newborn included. | Diagnostic test | – |
Primary outcome
Change in microbiome diversity
Time frame: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Shannon diversity index
Change in microbiome abundance
Time frame: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Number of reads for a given taxonomy.
Virus presence
Time frame: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Molecular detection of respiratory viruses using multiplex PCR.
2 secondary outcomes
Occurence of bronchopulmonary dysplasia
Time frame: At discharge from neonatology.
Change in expression of local innate immunity markers
Time frame: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No. Individual participant data will be anonymised.
Related trials for Microbial Colonization
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal swab in people with Microbial Colonization and Viral Infection, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microbiome diversity (time frame: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.