RecruitingPhase 1NCT06283355

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

Sponsor

Johns Hopkins University

Enrollment

175 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

Staphylococcus Aureus Microbial Colonization Neonatal Infection

Summary

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.

Eligibility

Min Age: 0 YearsMax Age: 60 Years

Inclusion Criteria7

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:
\. Parent/Adult provider is able to provide informed consent

Exclusion Criteria15

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