Intervention Group for Nose

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nose+3 MoreVaginal Seeding - Procedure
Eligibility
18 - 40
Female
What conditions do you have?
Select

Study Summary

This is a single-center, parallel-arm, blind, sham-controlled, feasibility randomized controlled trial (RCT) to be conducted in healthy cesarean-born infants. Eligible infants will be randomized 1:1 to have their nose swabbed with either maternal vaginal secretions or a sterile swab (intervention vs. control group, respectively) following birth by cesarean section (C-section). 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 infants born by C-section is feasible and that the intervention is safe.

Eligible Conditions
  • Nose
  • Microbiome
  • Cesarean Section
  • Vaginal Seeding

Treatment Effectiveness

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: One year following randomization

Month 6
Vagina
Immediately following administration of the intervention
Timing of the intervention
One year following randomization
Feasibility of the RCT
Proportion of in-person study visits completed
Safety of the intervention

Trial Safety

Trial Design

2 Treatment Groups

Intervention Group
1 of 2
Control Group
1 of 2

Active Control

Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention Group · Has Placebo Group · N/A

Intervention Group
Procedure
ActiveComparator Group · 1 Intervention: Vaginal Seeding · Intervention Types: Procedure
Control Group
Procedure
ShamComparator Group · 1 Intervention: Sterile Swab · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: one year following randomization

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,589 Previous Clinical Trials
46,945,767 Total Patients Enrolled
Vanderbilt University Medical CenterLead Sponsor
772 Previous Clinical Trials
600,512 Total Patients Enrolled
Christian Rosas-Salazar, MD, MPHPrincipal InvestigatorVanderbilt University Medical Center

Eligibility Criteria

Age 18 - 40 · Female Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have completed 3 or more prenatal care visits at Vanderbilt University Medical Center (VUMC) (any facility).
You are scheduled for a planned C-section due to a repeat C-section at VUMC (main campus only).
You are planning to have general pediatric care for the infant at VUMC (main campus or One Hundred Oaks campus).
You do not intend to relocate outside the middle Tennessee region within 18-24 months of recruitment.