Actively Recruiting
Modification Of The Early-Life Respiratory Microbiome Through Vaginal Seeding in Cesarean-Born Children
Led by Vanderbilt University Medical Center · Updated on 2025-11-10
20
Participants Needed
1
Research Sites
N/A
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
Researchers are studying the impact of vaginal seeding on the early-life upper respiratory tract microbiome in children born by cesarean section. This randomized controlled trial aims to test whether it is feasible and safe to perform this procedure, which attempts to expose cesarean-born children to maternal vaginal secretions similar to natural vaginal delivery. The study focuses on healthy children born by C-section and evaluates the potential changes in their respiratory microbiome over time. The trial randomly assigns eligible newborns to one of two groups: one group receives a nasal swab with maternal vaginal secretions immediately after birth and initial newborn care, while the control group receives a nasal swab with a sterile swab. Both mother and child continue with usual medical care after the procedure. Follow-up visits are planned at various times throughout the child's first six months to monitor safety and microbiome changes. An interim safety analysis will be conducted during the study. Participants will be involved in multiple assessments during the first six months of life, including nasal swabs at birth, around 2 days, 5 days, 4 weeks, and 6 months of age. Researchers will track the timing of the intervention, completion of study visits, and microbial ecology of both maternal vaginal and infant respiratory microbiomes. The main outcomes measured are the feasibility of conducting this trial and the safety of the vaginal seeding procedure. The total participation time extends to six months after randomization.
CONDITIONS
Brief 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 capable of consenting and complying with study procedures
- Singleton pregnancy
- Completed at least 3 prenatal care visits at Vanderbilt University Medical Center
- Underwent rectovaginal swab screening for Group B Streptococcus at 36 weeks gestation
- Scheduled (planned or non-emergency) cesarean section at Vanderbilt University Medical Center (main campus only)
- No plan to relocate outside the middle Tennessee region within 12 months
- Estimated gestational age of the child at least 37 weeks
- Expected birth weight of the child at least 2,500 grams
You will not qualify if you...
- Previous child with Group B Streptococcus infection or positive GBS testing
- Infection with hepatitis B, hepatitis C, HIV, genital herpes simplex virus, or genital human papilloma virus
- Type I or type II diabetes
- Laboratory evidence during current pregnancy of GBS bacteriuria, GBS colonization, chlamydia, trichomoniasis, gonorrhea, hepatitis B, hepatitis C, HIV, or syphilis
- Uncontrolled gestational diabetes
- Serious obstetric diseases such as severe preeclampsia, placental abruption, or thromboembolic disease
- Prior abnormal Pap smear
- Cesarean scheduled due to genitourinary infection interfering with vaginal delivery
- Missing prenatal screening tests
- Use of systemic antibiotics within 4 weeks before delivery (except during C-section)
- Use of systemic immunosuppressive, biologic, or chemotherapy agents in the 3 months before delivery (with some exceptions)
- Fever of 100.4°F (38°C) or higher in the 72 hours before delivery
- Symptoms indicating genitourinary infection or genital herpes on delivery day
- Symptoms suggesting acute infectious disease on delivery day
- Physical exam signs of genitourinary infection on delivery day
- Maternal vaginal pH higher than 4.5 on delivery day
- Emergency cesarean instead of scheduled C-section
- Prolonged rupture of membranes (18 hours or more before delivery)
- Pregnancy from assisted reproductive technology or surrogacy
- Participation in another clinical trial interfering with this study
- Other medical problems affecting safety, compliance, or data quality as determined by investigators
- Neonatal need for medical measures beyond routine care immediately after delivery
- Transfer to neonatal intensive care unit immediately after birth
- Presence of thick meconium during delivery
- Signs of neonatal 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 anomalies
- Participation in another clinical trial interfering with study data
- Other medical issues compromising safety, compliance, or data quality as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Immediately following birth
Immediately following birth by C-section and initial newborn care, participants will have their nasal cavity swabbed with either maternal vaginal secretions or a sterile swab according to their assigned group.
1 in-person treatment visit
Duration - 6 months
Participants will be followed with multiple assessments during the child's first 6 months of life to monitor safety and feasibility of the intervention and to collect microbiome data.
In-person visits at birth, approximately 2 days, 5 days, 4 weeks, and 6 months of age
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
A
Andrea E Lee, MA, MLS
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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