Parent-to-Child Nasal Microbiota Transplant to Promote Colonization Resistance to Staphylococcus Aureus
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
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 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 participant's infant(s) will create a healthy, diverse neonatal nasal microbiome.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: direct NMT swab parent nares then insert swab directly into neonate nares |
Biological: nasal microbiota transplant (NMT)
nasal microbiota transplant
|
| Experimental: indirect NMT swab parent nares, inoculate swab into saline, instill liquid into neonate nares |
Biological: nasal microbiota transplant (NMT)
nasal microbiota transplant
|
| Placebo Comparator: placebo instill sterile saline into neonate nares |
Biological: Placebo
Placebo sterile saline
|
Outcome Measures
Primary Outcome Measures
- Change in nasal microbiome diversity as assessed by linear discriminant analysis [Day 7, 14 days post-intervention]
We will perform linear discriminant analysis to identify differentially abundant microbial species between the groups. Alpha diversity metrics between NMT and placebo groups will be tested with bidirectional Wilcoxon test to compare alpha diversity metrics between 1) direct NMT and placebo group, 2) indirect NMT and placebo group, 3) direct NMT and indirect NMT groups.
Eligibility Criteria
Criteria
Inclusion Criteria:
Neonate:
-
Neonate has anticipated neonatal intensive care unit length of stay > 7 days,
-
Neonate ≥25 weeks gestation,
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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
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Parent/adult provider with signs or symptoms of a current or recent (last 7 days) respiratory illness (e.g. runny nose, congestion, fever, cough),
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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,
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins University | Baltimore | Maryland | United States | 21287 |
Sponsors and Collaborators
- Johns Hopkins University
- National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
- Principal Investigator: Aaron Milstone, Johns Hopkins University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00361302