MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT05505110
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • C-section
  • Microbiome
  • Respiratory
  • Vaginal Seeding

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Vaginal Seeding — BIOLOGICAL
    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.
  • Sterile Swab — OTHER
    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.

Study Details

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 Dates

Start date
Nov 9, 2022
Status verified
Nov 2025
Primary completion
Aug 10, 2028
Completion
Aug 10, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Intervention Group
    Vaginal Seeding
  • Sham Comparator: Control Group
    Sterile Swab

Primary Outcome Measure

Feasibility of the RCT [ Time Frame: Six months following randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Andrea E Lee
[email protected]
615-936-5552

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By research site
Vanderbilt University Medical Center· Nashville, TN

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