Actively Recruiting
MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing
Led by Vanderbilt University Medical Center · Updated on 2025-11-10
20
Participants Needed
1
Research Sites
300 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 40 years in good general health who can provide consent and comply with study procedures
- Singleton pregnancy
- At least 3 prenatal care visits at Vanderbilt University Medical Center
- Underwent rectovaginal swabs at 36 weeks gestation for Group B Streptococcus screening
- Scheduled C-section at Vanderbilt University Medical Center main campus
- No plans to move outside middle Tennessee region within 12 months
- Estimated gestational age of baby 37 weeks or more
- Baby birth weight of 2,500 grams or more
You will not qualify if you...
- Mother with previous child with Group B Streptococcus infection or positive testing
- Mother with hepatitis B, hepatitis C, HIV infection
- Mother with genital herpes simplex virus infection or prior positive genital HSV testing
- Mother with genital human papilloma virus infection or prior positive genital HPV testing
- Mother with type I or type II diabetes
- Current pregnancy with GBS bacteriuria or colonization at 36 weeks gestation
- Chlamydia, trichomoniasis, or gonorrhea detected at 36 weeks gestation
- Hepatitis B, hepatitis C, HIV, or syphilis detected at 36 weeks gestation
- Uncontrolled gestational diabetes
- Serious obstetric disease (e.g., severe preeclampsia, placental abruption, thromboembolic disease)
- Prior abnormal Pap smear
- C-section scheduled due to genitourinary infection interfering with vaginal delivery
- Lack of prenatal screening tests
- Use of systemic antibiotics within 4 weeks before delivery (except during C-section)
- Use of systemic immunosuppressive, biologic, or chemotherapy agents within 3 months before delivery (except certain prenatal steroids)
- Fever (≥100.4°F/38°C) within 72 hours before delivery
- Symptoms suggesting genitourinary infection on day of delivery
- Symptoms suggesting genital HSV infection on day of delivery
- Symptoms suggesting acute infectious disease on day of delivery
- Physical exam findings suggesting genitourinary infection on day of delivery
- Maternal vaginal pH greater than 4.5 on day of delivery
- Change from scheduled to emergency C-section
- Prolonged rupture of membranes (≥18 hours before delivery)
- Pregnancy via assisted reproductive technology or surrogacy
- Participation in another clinical trial affecting study data
- Other medical problems compromising safety, compliance, or data quality
- Newborn needing neonatal measures beyond routine care at delivery
- Newborn transferred to neonatal intensive care immediately after delivery
- Thick meconium noted during delivery
- Newborn physical exam suggesting acute respiratory distress after delivery
- Prenatal diagnosis of serious genetic, respiratory, cardiovascular, or neurological disease
- Prenatal diagnosis of intrauterine growth restriction
- Prenatal diagnosis of major congenital anomaly
- Newborn participation in another clinical trial affecting study data
- Other medical problems in newborn compromising safety, compliance, or data quality
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
M
MOTHER SEED Study Team
CONTACT
A
Andrea E Lee, MA, MLS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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