Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome (NCT06283355) | Clinical Trial Compass
RecruitingPhase 1
Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome
United States175 participantsStarted 2024-09-03
Plain-language summary
This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the neonatal microbiome and increase the neonatal microbiome diversity.
Who can participate
Age range
0 Years – 60 Years
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
. Neonate has anticipated NICU length of stay \> 7 days
. Neonate ≥25 weeks gestation
. At least one parent/adult provider not colonized with S. aureus (as determined by baseline screening)
. Neonate is not colonized with S. aureus on baseline screening
Exclusion criteria
. Neonate has had a prior clinical or surveillance culture grow S. aureus
. Neonate is a ward of the State
. Neonate with antenatal suspicion for immunodeficiency (e.g. sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
. Neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)
. Parent/adult provider had positive COVID-19 test in prior 21 days
. Parent/adult provider with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)
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
Neonatal nasal microbiome diversity after intervention
Timeframe: Day 2, 4, 7, 10, 14 days post-intervention