MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: For the mother: * Female 18-40 years of age who is in good general health, is fully able to provide consent to participate in the study, anticipates being available for the duration of the study, and is willing to comply with all study procedures * Singleton pregnancy * Completed ≧3 prenatal care visits at Vanderbilt University Medical Center (any facility) * Having rectovaginal swabs collected at ≧36 weeks of gestation to screen for Group B Streptococcus (GBS) as part of prenatal screening tests * Having a scheduled (planned or non-emergency) C-section at Vanderbilt University Medical Center (main campus only) * No intent to relocate outside the middle Tennessee region within 12 months of recruitment For the child: * Estimated gestational age ≧37 weeks * Birth weight ≧2,500 grams Exclusion Criteria: For the mother: * Past medical history of any of the following: * Previous child with GBS infection or prior positive GBS testing * Hepatitis B, hepatitis C, or human i