Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.

Part of paid clinical trials in Falls Church, Virginia.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT03298334
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Cesarean Delivery Affecting Newborn
  • Gastrointestinal Microbiome
  • Host Microbial Interactions
  • Intestinal Microbiome
  • Microbiota
  • Obesity, Childhood

Eligibility Criteria

Sex
ALL
Age
0 Days - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Vaginal Seeding — BIOLOGICAL
    A gauze containing the Mother's vaginal flora will be swabbed over the face and body of the neonate shortly after cesarean delivery.
  • No Vaginal Seeding — OTHER
    A gauze carrying sterile saline will be swabbed over the face and body of the neonate shortly after cesarean delivery.

Study Details

Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.

Key Dates

Start date
Jul 1, 2018
Status verified
Jun 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Receives Vaginal Seeding
  • Sham Comparator: No Vaginal Seeding

Primary Outcome Measure

Adiposity [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Inova Health SystemFalls ChurchVirginia22042
Suchitra Hourigan, MD
[email protected], [email protected]
703-776-8489
General Information
[email protected]
Ankit Shah, MD (SUB_INVESTIGATOR)

Find similar trials in Falls Church, VA

By research site
Inova Health System· Falls Church, VA

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