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| ID | Type | Description | Link |
|---|---|---|---|
| R21AI179644 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This feasibility and safety 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.
The parent-to-child NMT study is a pilot study to test the feasibility of a parent-to-child nasal microbiome transplant. The investigators will test parent-to-neonate nasal microbiome transplantation as an intervention to reduce S. aureus acquisition in neonates. Neonates admitted to the Johns Hopkins Hospital 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 neonates, eligible neonates will undergo a nasal microbiome transplant. This pilot study looks to determine whether transferring a parents healthy, diverse nasal microbiota to the infant(s) will create a healthy, diverse neonatal nasal microbiome. The investigators are planning an upcoming randomized controlled trial of this intervention and hope to establish feasibility during this pilot study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| direct NMT | Experimental | swab parent nares then insert swab directly into neonate nares |
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| indirect NMT | Experimental | swab parent nares, inoculate swab into saline, instill liquid into neonate nares |
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| placebo | Placebo Comparator | instill sterile saline into neonate nares |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nasal microbiota transplant (NMT) | Biological | nasal microbiota transplant |
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| Measure | Description | Time Frame |
|---|---|---|
| Neonatal nasal microbiome diversity after intervention | This outcome will be determined by analysis of periodic surveillance swabs collected after intervention. | Day 4, 7, 10, 14 days post-intervention |
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Inclusion Criteria:
Neonate:
Parent/adult provider:
1. Parent/adult provider is able to provide informed consent.
Exclusion Criteria:
Neonate:
Parent/adult Provider:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Milstone | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Placebo | Biological | Placebo sterile saline |
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| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |