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

Johns Hopkins University

Status and phase: Enrolling; Phase 1

Conditions: Microbial Colonization; Neonatal Infection; Staphylococcus Aureus

Treatments: Biological: Placebo; Biological: Nasal Microbiota Transplant (NMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06283355

IRB00433691

Details and patient eligibility

About

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.

Full description

This parent-to-child NMT study will test the effect of an anterior nares, or nasal, microbiota transplant (NMT) on seeding, engraftment, and diversity of the neonatal microbiome. Neonates admitted to the Johns Hopkins Neonatal Intensive Care Unit (NICU) will be screened and parents will be approached for enrollment in the study. After consent and baseline screening of parents and neonates, eligible neonates will undergo an NMT.

Enrollment: 175 estimated patients

Sex: All

Ages: Under 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 3 patient groups, including a placebo group

Single NMT

Experimental group

Description:

Swab parent nares then insert swab directly into neonate nares once.

Treatment:

Biological: Nasal Microbiota Transplant (NMT)

Repeat NMT

Experimental group

Description:

Swab parents nares then insert swab directly into neonate nares multiple times.

Treatment:

Biological: Nasal Microbiota Transplant (NMT)

Placebo

Placebo Comparator group

Description:

Insert a sterile swab into neonate nares.

Treatment:

Biological: Placebo