MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing — MOTHER SEED  

Cesarean Section Clinical Trial

Official title: MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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 C-section. The procedure will be performed immediately after the initial newborn care by the general pediatric team. The mother and infant 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 year of life. One planned interim analysis to assess the safety of the procedure will be conducted.

The intervention aims to transfer the maternal vaginal microbiome to the nasal cavity of cesarean-born infants at birth (i.e., vaginal seeding of the URT). Hence, the intervention simply attempts to replicate the natural exposure to maternal vaginal secretions during vaginal delivery in infants born by C-section. ;

Related Conditions & MeSH terms

• Cesarean Section
• Microbiome

• NCT number: NCT05505110
• Study type: Interventional
• Source: Vanderbilt University Medical Center
• Contact: MOTHER SEED Study Team
• Phone: 615-936-5552
• Email: motherseed@vumc.org
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2022
• Completion date: August 10, 2026