RECRUITING

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

Conditions

Staphylococcus Aureus Microbial Colonization Neonatal Infection microbiome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-09-03

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06283355

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.

Ages Eligible for Study:0 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Danielle Koontz

CONTACT

443-287-9040

dkoontz1@jhmi.edu

Principal Investigator

Aaron Milstone, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins University

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Aaron Milstone, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-03

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-09-03

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

microbiome

Additional Relevant MeSH Terms

Staphylococcus Aureus
Microbial Colonization
Neonatal Infection