Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant to Promote Colonization Resistance to Staphylococcus Aureus

Conditions
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Staphylococcus Aureus, Microbial Colonization, Neonatal Infection

Intervention / Treatment
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* Biological: nasal microbiota transplant (NMT)
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonate: Neonate has anticipated NICU 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. 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 Parent/adult provider with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough) Parent/adult 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? 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 pathogen. 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. Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire

Ages Eligible for Study
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Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: direct NMT<br>swab parent nares then insert swab directly into neonate nares | Biological: nasal microbiota transplant (NMT)<br>* nasal microbiota transplant<br>|
| Experimental: indirect NMT<br>swab parent nares, inoculate swab into saline, instill liquid into neonate nares | Biological: nasal microbiota transplant (NMT)<br>* nasal microbiota transplant<br>|
| Placebo Comparator: placebo<br>instill sterile saline into neonate nares | Biological: Placebo<br>* Placebo sterile saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome