Active — Not RecruitingPhase 1

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

United States34 participantsStarted 2023-10-25

Plain-language summary

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.

Who can participate

Age range60 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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 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.

What they're measuring

Neonatal nasal microbiome diversity after intervention

Timeframe: Day 4, 7, 10, 14 days post-intervention

Trial details

NCT IDNCT05695196

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-06

View on ClinicalTrials.gov More Staphylococcus Aureus trials