Newborn; InfectionNEONATMICROBIONCT06389383
Pilot Study - Monitoring the Nasal Microbiome and Viral Respiratory Infections in Newborn Hospitalized in Neonatalogy.
A study testing Nasal Swab in people with Newborn; Infection, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Newborn; Infection
- What is being tested?
- Nasal Swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2022to 13 Nov 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Nasal Swab
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal SwabOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Nasal Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of viral infections
Measured: from baseline to end of hospitalization (up to 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start21 Dec 2022
- Primary completion30 Jun 2023
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn; InfectionStudies 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
- NCT06389383
- Sponsor's protocol ID
- 22-0182
- Acronym
- NEONATMICROBIO
- Status last verified
- Jul 2025
- First submitted
- 23 Apr 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06389383
- Acronym / sponsor ID
- NEONATMICROBIO / 22-0182
- Conditions
- Newborn; Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 29 Apr 2024 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal swab | Other | 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 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 | Other | Nasal swab |
Primary outcome
rate of viral infections
Time frame: from baseline to end of hospitalization (up to 2 months)
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 24 Jul 2025.
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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 Newborn; 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 24 Jul 2025. 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?
rate of viral infections (time frame: from baseline to end of hospitalization (up to 2 months)). 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 24 Jul 2025.