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NCT05695196
Parent-to-Child Nasal Microbiota Transplant to Promote Colonization Resistance to Staphylococcus Aureus
Conditions: Staphylococcus Aureus, Microbial Colonization, Neonatal Infection
Sex: All
Ages: N/A – 60 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 200
Sponsor: Johns Hopkins University
Location: United States
Summary
This pilot study looks to determine whether transferring a parents healthy, diverse nasal microbiota to the participant's infant(s) will create a healthy, diverse neonatal nasal 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. aureusNeonate is a ward of the StateNeonate 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 daysParent/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.
Source: ClinicalTrials.gov (NCT05695196). StuddyBuddy aggregates publicly available trial information.