[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537863":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":62,"collaborators":30,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":30,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":30,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":46,"whyStopped":30,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Single NMT","EXPERIMENTAL","Swab parent nares then insert swab directly into neonate nares once.",[13],"Biological: Nasal Microbiota Transplant (NMT)",{"label":15,"type":10,"description":16,"interventionNames":17},"Repeat NMT","Swab parents nares then insert swab directly into neonate nares multiple times.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo","PLACEBO_COMPARATOR","Insert a sterile swab into neonate nares.",[23],"Biological: Placebo",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","Nasal Microbiota Transplant (NMT)","nasal microbiota transplant",[15,9],null,{"type":26,"name":19,"description":32,"armGroupLabels":33,"otherNames":30},"Placebo sterile swab",[19],[35],{"name":36,"affiliation":5,"role":37},"Aaron Milstone, MD","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":30,"email":43},"Danielle Koontz","CONTACT","443-287-9040","dkoontz1@jhmi.edu",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Baltimore","Maryland","21287","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-76.61219,39.29038,{"lat":56,"lon":55},[59,60],{"name":40,"role":41,"phone":42,"phoneExt":30,"email":43},{"name":61,"role":37,"phone":30,"phoneExt":30,"email":30},"Aaron Milstone",{"type":63,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100537863","phase-1-comparing-single-versus-repeat-nmt-on-the-diversity-of-the-neonatal-nasal-microbiome-100537863",false,"NCT06283355","Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome","Comparing Single Versus Repeat Parent-to-Child Nasal Microbiome Transplant on Seeding, Engraftment, and Diversity of the Neonatal Nasal Microbiome","Inclusion Criteria:\n\nNeonate:\n\n1. Neonate has anticipated NICU length of stay \\> 7 days\n2. Neonate ≥25 weeks gestation\n3. At least one parent\u002Fadult provider not colonized with S. aureus (as determined by baseline screening)\n4. Neonate is not colonized with S. aureus on baseline screening\n\nParent\u002FAdult provider:\n\n1\\. Parent\u002FAdult provider is able to provide informed consent\n\nExclusion Criteria:\n\nNeonate:\n\n1. Neonate has had a prior clinical or surveillance culture grow S. aureus\n2. Neonate is a ward of the State\n3. Neonate with antenatal suspicion for immunodeficiency (e.g. sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)\n4. Neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)\n\nParent\u002FAdult provider:\n\n1. Parent\u002Fadult provider had positive COVID-19 test in prior 21 days\n2. Parent\u002Fadult provider with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)\n3. Parent\u002Fadult 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?\n4. Parent\u002Fadult provider tests positive on baseline screening test for S. aureus nasal colonization.\n5. Parent\u002Fadult provider tests positive on baseline screening test for a respiratory pathogen.\n6. Parent\u002Fadult provider is not able to provide written informed consent\n7. Parent\u002Fadult provider is not able to be present at the bedside at the time of intervention.\n8. Parent\u002Fadult provider has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.\n9. Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire",true,"ALL","0 Years","60 Years",{"count":76,"type":77},175,"ESTIMATED","INTERVENTIONAL",[80],"PHASE1","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.",[83,84,85],"Staphylococcus Aureus","Microbial Colonization","Neonatal Infection",[87],"microbiome","2026-06-04",{"date":90,"type":91},"2026-06-08","ACTUAL",{"date":93,"type":91},"2024-09-03",{"date":95,"type":77},"2026-12-31",{"name":5,"class":6},1]