Nasal Microbiota Transplant for Preventing Newborn Infections
(ParentsTREAT Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAaron Milstone

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Johns Hopkins University

Trial Summary

What is the purpose of this trial?

This trial is testing if transferring healthy bacteria from a parent's nose to their newborn's nose can help protect the baby from harmful bacteria. The study focuses on newborns at Johns Hopkins Hospital. By creating a healthy bacterial environment in the baby's nose, the researchers hope to reduce the risk of infections.

Research Team

Aaron Milstone

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for newborns who are expected to stay in the neonatal intensive care unit for over a week and are at least 25 weeks gestation. They must not be colonized with S. aureus, nor should their parent/provider, who also needs to consent and be free of respiratory illness or recent COVID-19.

Inclusion Criteria

Parent/adult provider is able to provide informed consent

At least one parent/adult provider not colonized with S. aureus (as determined by baseline screening)

Neonate has anticipated NICU length of stay > 7 days

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Exclusion Criteria

Parent/adult provider tests positive on baseline screening test for S. aureus nasal colonization

Neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)

I am experiencing symptoms like a runny nose, congestion, fever, or cough.

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Treatment Details

Interventions

Nasal Microbiota Transplant (Microbiota Transplant)
Placebo (Procedure)

Trial OverviewThe study tests if transferring healthy nasal microbiota from a parent to their infant can establish a diverse nasal microbiome in the baby. Infants will either receive this nasal microbiota transplant (NMT) or a placebo.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: indirect NMTExperimental Treatment1 Intervention

swab parent nares, inoculate swab into saline, instill liquid into neonate nares

Group II: direct NMTExperimental Treatment1 Intervention

swab parent nares then insert swab directly into neonate nares

Group III: placeboPlacebo Group1 Intervention

instill sterile saline into neonate nares