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Compares treatment options for Staphylococcus Aureus
Official title Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome
ClinicalTrials.gov ID: NCT06283355
What this study is testing
What is Nasal Microbiota Transplant (NMT)?
Nasal Microbiota Transplant (NMT) is an investigational medicine, being studied as a potential treatment for staphylococcus aureus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Neonate:
- 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 Parent/Adult provider: 1\. Parent/Adult provider is able to provide informed consent
You likely can't join if
- Neonate:
- 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...
- Neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing) Parent/Adult provider:
- Parent/adult provider had positive COVID-19 test in prior 21 days
See the full eligibility criteria
- Neonate:
- 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 Parent/Adult provider: 1\. Parent/Adult provider is able to provide informed consent
- Neonate:
- 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:
- 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)
- Parent/adult provider has been in close contact with someone in the last 7 days who had a respiratory viral infection, like the cold or the flu?
- Parent/adult provider tests positive on baseline screening test for S. aureus nasal colonization.
- Parent/adult provider tests positive on baseline screening test for a respiratory pathogen.
- Parent/adult provider is not able to provide written informed consent
- Parent/adult provider is not able to be present at the bedside at the time of intervention.
- Parent/adult provider has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.
- Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.