Comparing Single Versus Repeat Parent-to-Child Nasal Microbiome Transplant on Seeding, Engraftment, and Diversity of the Neonatal Nasal Microbiome
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 78
- 试验地点
- 3
- 主要终点
- Neonatal nasal microbiome diversity after intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Single NMT
Swab parent nares then insert swab directly into neonate nares once.
干预措施: Nasal Microbiota Transplant (NMT) (Biological)
Repeat NMT
Swab parents nares then insert swab directly into neonate nares multiple times.
干预措施: Nasal Microbiota Transplant (NMT) (Biological)
Placebo
Insert a sterile swab into neonate nares.
干预措施: Placebo (Biological)
结局指标
主要结局
Neonatal nasal microbiome diversity after intervention
时间窗: Day 2, 4, 7, 10, 14 days post-intervention
This outcome will be determined by analysis of periodic surveillance swabs collected after intervention.
次要结局
未报告次要终点