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Recruiting NCT06283355

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

Phase I Interventional Staphylococcus Aureus Microbial Colonization Neonatal Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nasal Microbiota Transplant (NMT), Placebo.
Who it may be relevant to
Registry conditions: Staphylococcus Aureus, Microbial Colonization, Neonatal Infection. Basic parameters: 0 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed 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.

Interventions

  • Biological Nasal Microbiota Transplant (NMT)
    nasal microbiota transplant
  • Biological Placebo
    Placebo sterile swab

Primary outcome measures

  • Neonatal nasal microbiome diversity after intervention [Time frame: Day 2, 4, 7, 10, 14 days post-intervention]

Eligibility criteria

Inclusion criteria

Neonate:

  • 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

Parent/Adult provider:

1\. Parent/Adult provider is able to provide informed consent

Exclusion criteria

Neonate:

  • 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:

  • 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.
  • Parent/adult provider tests positive on baseline screening test for a respiratory pathogen.
  • Parent/adult provider is not able to provide written informed consent
  • Parent/adult provider is not able to be present at the bedside at the time of intervention.
  • Parent/adult provider has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.
  • Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Johns Hopkins University — Baltimore

Identifiers

NCT: NCT06283355 · IRB00433691

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗