Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Staphylococcus Aureus, Microbial Colonization, Neonatal Infection
In brief
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.
Key facts
- Study ID
- NCT06283355
- Run by
- Johns Hopkins University
- People needed
- 175
- Starts
- 2024-09-03
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-06-08
Who can join
Age: any, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify 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:
- Parent/Adult provider is able to provide informed consent
You may not qualify 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 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
Where it is running
- Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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