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RECRUITING
NCT05505110
EARLY_PHASE1

MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

Summary

This is a single-center, parallel-arm, blind, sham-controlled, feasibility randomized controlled trial (RCT) to be conducted in healthy cesarean-born children. Eligible children will be randomized 1:1 to have their nose swabbed with either maternal vaginal secretions or a sterile swab (intervention vs. control group, respectively). 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 children born by cesarean section (C-section) is feasible and that the intervention is safe.

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-11-09

Completion Date

2028-08-10

Last Updated

2025-11-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

Vaginal Seeding

Following birth by C-section and immediately after the initial newborn care by the general pediatric team, children randomized to the intervention group will have their nasal cavity swabbed with maternal vaginal secretions.

OTHER

Sterile Swab

Following birth by C-section and immediately after the initial newborn care by the general pediatric team, children randomized to the control group will have their nasal cavity swabbed with a sterile swab.

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States