Actively Recruiting
Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome
Led by Johns Hopkins University · Updated on 2025-09-11
175
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonate has an expected NICU stay longer than 7 days
- Neonate is at least 25 weeks gestational age
- At least one parent or adult provider is not colonized with Staphylococcus aureus based on baseline screening
- Neonate is not colonized with Staphylococcus aureus on baseline screening
- Parent or adult provider is able to provide informed consent
You will not qualify if you...
- Neonate has had a prior clinical or surveillance culture positive for Staphylococcus aureus
- Neonate is a ward of the State
- Neonate has antenatal suspicion for immunodeficiency (such as sibling with known immunodeficiency or genetic syndrome with immunodeficiency)
- Neonate cannot have nasal swabs collected due to anatomical or clinical reasons (e.g., nasal packing)
- Parent or adult provider had a positive COVID-19 test in the past 21 days
- Parent or adult provider has symptoms of respiratory illness (runny nose, congestion, fever, cough)
- Parent or adult provider has been in close contact within the last 7 days with someone who had a respiratory viral infection
- Parent or adult provider tests positive for Staphylococcus aureus nasal colonization on baseline screening
- Parent or adult provider tests positive for a respiratory pathogen on baseline screening
- Parent or adult provider is unable to provide written informed consent
- Parent or adult provider cannot be present at the bedside during the intervention
- Parent or adult provider has a history of chronic sinusitis, cystic fibrosis, or infection with a multi-drug resistant organism
- Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on it
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
D
Danielle Koontz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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