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Clinical Trial Summary

This is a single-center, parallel-arm, blind, sham-controlled, feasibility randomized controlled trial (RCT) to be conducted in healthy cesarean-born infants. Eligible infants will be randomized 1:1 to have their nose swabbed with either maternal vaginal secretions or a sterile swab (intervention vs. control group, respectively) following birth by cesarean section (C-section). The main hypothesis is that conducting an RCT assessing the utility of vaginal seeding in modifying the early-life upper respiratory tract (URT) microbiome of infants born by C-section is feasible and that the intervention is safe.


Clinical Trial Description

Eligible infants will be randomized 1:1 to have their nose swabbed with either maternal vaginal secretions or a sterile swab (intervention vs. control group, respectively) following birth by C-section. The procedure will be performed immediately after the initial newborn care by the general pediatric team. The mother and infant will then receive usual medical care as determined by their health care providers. Follow-up will occur at multiple time points during the child's first year of life. One planned interim analysis to assess the safety of the procedure will be conducted. The intervention aims to transfer the maternal vaginal microbiome to the nasal cavity of cesarean-born infants at birth (i.e., vaginal seeding of the URT). Hence, the intervention simply attempts to replicate the natural exposure to maternal vaginal secretions during vaginal delivery in infants born by C-section. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05505110
Study type Interventional
Source Vanderbilt University Medical Center
Contact MOTHER SEED Study Team
Phone 615-936-5552
Email motherseed@vumc.org
Status Recruiting
Phase N/A
Start date November 9, 2022
Completion date August 10, 2026

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