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

Launched by JOHNS HOPKINS UNIVERSITY · Feb 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a nasal microbiota transplant (NMT) from a parent to their newborn can help improve the variety of healthy bacteria in the baby's nose. Researchers want to see if introducing these parental microbes can make the baby's nasal microbiome more diverse, which is important for their health, especially in preventing infections like those caused by Staphylococcus aureus.

To participate, newborns must be expected to stay in the Neonatal Intensive Care Unit (NICU) for more than a week, be at least 25 weeks old at birth, and not have any S. aureus bacteria in their system. Additionally, at least one parent or adult caregiver needs to be free of S. aureus. Participants will undergo screening and, if eligible, will receive the transplant to see how it affects the baby's nasal bacteria. It's also important for parents to know that certain health conditions or recent illnesses could prevent them from participating. The trial is currently looking for eligible participants, and the information gathered will help improve our understanding of neonatal health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Neonate:
• • 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
• Parent/Adult provider:
• • 1. Parent/Adult provider is able to provide informed consent
• Exclusion Criteria:
• Neonate:
• • 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)
• Parent/Adult provider:
• • 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