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Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Summary
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.
Official title: Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
0 Days - 50 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2018-07-01
Completion Date
2029-04
Last Updated
2025-06-08
Healthy Volunteers
Yes
Conditions
Interventions
Vaginal Seeding
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
A gauze carrying sterile saline will be swabbed over the face and body of the neonate shortly after cesarean delivery.
Locations (1)
Inova Health System
Falls Church, Virginia, United States