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NCT06283355
Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome
Conditions: Staphylococcus Aureus, Microbial Colonization, Neonatal Infection
Sex: All
Ages: 0 Years – 60 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 78
Sponsor: Johns Hopkins University
Location: Johns Hopkins University Baltimore Maryland
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.
Eligibility Criteria
Inclusion Criteria:
Neonate:
1. Neonate has anticipated NICU length of stay \> 7 days
2. Neonate ≥25 weeks gestation
3. At least one parent/adult provider not colonized with S. aureus (as determined by baseline screening)
4. Neonate is not colonized with S. aureus on baseline screening
Parent/Adult provider:
1\. Parent/Adult provider is able to provide informed consent
Exclusion Criteria:
Neonate:
1. Neonate has had a prior clinical or surveillance culture grow S. aureus
2. Neonate is a ward of the State
3. Neonate with antenatal suspicion for immunodeficiency (e.g. sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
4. Neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)
Parent/Adult provider:
1. Parent/adult provider had positive COVID-19 test in prior 21 days
2. Parent/adult provider with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)
3. 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?
4. Parent/adult provider tests positive on baseline screening test for S. aureus nasal colonization.
5. Parent/adult provider tests positive on baseline screening test for a respiratory pathogen.
6. Parent/adult provider is not able to provide written informed consent
7. Parent/adult provider is not able to be present at the bedside at the time of intervention.
8. Parent/adult provider has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.
9. Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire
Source: ClinicalTrials.gov (NCT06283355). StuddyBuddy aggregates publicly available trial information.