Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome

Description

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.

Conditions

Staphylococcus Aureus, Microbial Colonization, Neonatal Infection

Study Overview

Study Details

Study overview

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.

Comparing Single Versus Repeat Parent-to-Child Nasal Microbiome Transplant on Seeding, Engraftment, and Diversity of the Neonatal Nasal Microbiome

Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome

Condition
Staphylococcus Aureus
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Neonate has anticipated NICU length of stay \> 7 days
  • 2. Neonate ≥25 weeks gestation
  • 3. At least one parent/adult provider not colonized with S. aureus (as determined by baseline screening)
  • 4. Neonate is not colonized with S. aureus on baseline screening
  • 1. Parent/Adult provider is able to provide informed consent
  • 1. Neonate has had a prior clinical or surveillance culture grow S. aureus
  • 2. Neonate is a ward of the State
  • 3. Neonate with antenatal suspicion for immunodeficiency (e.g. sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)
  • 4. Neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)
  • 1. Parent/adult provider had positive COVID-19 test in prior 21 days
  • 2. Parent/adult provider with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)
  • 3. 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?
  • 4. Parent/adult provider tests positive on baseline screening test for S. aureus nasal colonization.
  • 5. Parent/adult provider tests positive on baseline screening test for a respiratory pathogen.
  • 6. Parent/adult provider is not able to provide written informed consent
  • 7. Parent/adult provider is not able to be present at the bedside at the time of intervention.
  • 8. Parent/adult provider has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.
  • 9. Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire

Ages Eligible for Study

0 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Johns Hopkins University,

Aaron Milstone, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2026-12-31