Phase
Condition
Staphylococcal Infections
Treatment
nasal microbiota transplant (NMT)
Placebo
Clinical Study ID
Ages < 60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion 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 bybaseline screening)
Neonate is not colonized with S. aureus on baseline screening
Parent/adult provider:
- Parent/adult provider is able to provide informed consent.
Exclusion
Exclusion Criteria:
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 knownimmunodeficiency, genetic syndrome with known associated immunodeficiency)
Neonate cannot have nasal swabs collected (due to anatomic or other clinicalintervention, 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. runnynose, congestion, fever, cough)
Parent/adult provider has been in close contact with someone in the last 7 days whohad a respiratory viral infection, like the cold or the flu?
Parent/adult provider tests positive on baseline screening test for S. aureus nasalcolonization.
Parent/adult provider tests positive on baseline screening test for a respiratorypathogen.
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 ofintervention.
Parent/adult provider has history of chronic sinusitis, cystic fibrosis, or aninfection with a multi-drug resistant organism.
Inability or unwillingness to complete the Donor questionnaire or a positiveresponse to any question on the Donor questionnaire
Study Design
Study Description
Connect with a study center
Johns Hopkins University
Baltimore, Maryland 21287
United StatesSite Not Available
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