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This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment
This parent-to-child NMT study will test the effect of an anterior nares, or nasal, microbiota transplant (NMT) on seeding, engraftment, and diversity of the neonatal microbiome following nasal decolonization for S. aureus. Infants admitted to the Johns Hopkins Neonatal Intensive Care Unit (NICU) will be screened and parents will be approached for enrollment in the study. After consent and baseline screening of parents and infants, eligible infants will undergo an NMT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single NMT | Experimental | Swab parent nares then insert swab directly into child nares once. |
|
| Repeat NMT | Experimental | Swab parents nares then insert swab directly into child nares multiple times. |
|
| Placebo | Placebo Comparator | Insert a sterile swab into child nares. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Microbiota Transplant (NMT) | Biological | nasal microbiota transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric nasal microbiome diversity after parent-to-child NMT. | This outcome will be determined by analysis of periodic surveillance swabs collected after intervention. | Day 2, 4, 7, 10, 14 days post-intervention |
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Child:
Inclusion criteria
Exclusion criteria
Donor:
Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle Koontz, Research Manager | Contact | 4432879040 | dkoontz1@jhmi.edu | |
| Slade Decker, Senior Research Coordinator | Contact | 4109550405 | sdecker9@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Aaron M Milstone, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Placebo | Biological | Placebo sterile swab |
|
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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