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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Johns Hopkins University — Baltimore

Идентификаторы

NCT: NCT06283355 · IRB00433691

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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