Follow-up of the Nasal Microbiome and Viral Infections in Newborns Hospitalised in Neonatology. (NCT05717283) | Clinical Trial Compass
CompletedNot Applicable
Follow-up of the Nasal Microbiome and Viral Infections in Newborns Hospitalised in Neonatology.
France38 participantsStarted 2022-12-20
Plain-language 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.
Who can participate
Age range
48 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in microbiome diversity
Timeframe: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
2
Change in microbiome abundance
Timeframe: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
3
Virus presence
Timeframe: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).