Parent-to-Child Nasal Microbiota Transplant to Promote Colonization Resistance to Staphylococcus Aureus
Staphylococcus Aureus, Microbial Colonization, Neonatal Infection
About this trial
This is an interventional prevention trial for Staphylococcus Aureus focused on measuring microbiome
Eligibility Criteria
Inclusion Criteria: Neonate: Neonate has anticipated neonatal intensive care unit 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. 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 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 a current or recent (last 7 days) respiratory illness (e.g. runny nose, congestion, fever, cough), 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 virus, 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.
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
direct NMT
indirect NMT
placebo
swab parent nares then insert swab directly into neonate nares
swab parent nares, inoculate swab into saline, instill liquid into neonate nares
instill sterile saline into neonate nares