Study Comparing Single and Multiple Parent-to-Child Nasal Microbiome Transplants to Improve Neonatal Nasal Microbiome Diversity

What this Trial Is About

Researchers are studying whether a nasal microbiota transplant NMT from parent to child can successfully transfer and establish beneficial bacteria in the noses of newborns, increasing the variety of microbes. This study focuses on neonates admitted to a neonatal intensive care unit NICU, aiming to learn how different NMT approaches affect the babys nasal microbiome. The study compares three groups one receiving a single NMT, another receiving multiple NMTs, and a control group receiving a placebo sterile swab. Parents nasal bacteria are collected and then transferred to the newborns nose either once or multiple times, depending on the group. This transplant process is done after screening and consent. The research is conducted under phase 1 conditions, with random assignment but no masking. Participants and their parents will be monitored over two weeks after treatment, with nasal samples collected on days 2, 4, 7, 10, and 14 to measure the diversity of the neonatal nasal microbiome. The study involves screening for infections, consent procedures, and careful observation of the microbiome changes. The total age range for participants is from birth up to 60 years for parent providers, and the study runs through the end of 2026.

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