MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing
Vanderbilt University Medical Center
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.
Description
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 procedure will be performed following birth by C-section and immediately after the initial newborn care by the general pediatric team. The mother and child will then receive usual medical care as determined by their health care providers. Follow-up will occur at multiple time points during the child's first 6 months of life. One planned interim analysis to assess the safety of the procedure will be conducted. The inte…
Eligibility
- Age range
- 18–40 years
- Sex
- Female
- Healthy volunteers
- No
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 Univ…
Interventions
- BiologicalVaginal 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.
- OtherSterile 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.
Location
- Vanderbilt University Medical CenterNashville, Tennessee