Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.

Summary

Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.

Conditions

• Cesarean Delivery Affecting Newborn
• Obesity, Childhood
• Intestinal Microbiome
• Microbiota
• Host Microbial Interactions
• Gastrointestinal Microbiome

Interventions

BIOLOGICAL

Vaginal Seeding

A gauze containing the Mother's vaginal flora will be swabbed over the face and body of the neonate shortly after cesarean delivery.

OTHER

No Vaginal Seeding

A gauze carrying sterile saline will be swabbed over the face and body of the neonate shortly after cesarean delivery.

Sponsors & Collaborators

• Johns Hopkins University

  collaborator OTHER

• Rutgers University

  collaborator OTHER

• Inova Health Care Services

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Suchitra Hourigan, MD, Chief, Clinical Microbiome Unit, NIAID, Pediatric Gastroenterologist · National Institute of Allergy and Infectious Diseases (NIAID), Inova Children's Hospital

• Noel Mueller, PhD · Johns Hopkins University

• Maria Gloria Dominguez Bello, PhD · Rutgers University

• Lawrence Appel, MD, MPH · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

0 Days

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-07-01

Primary Completion

2027-04-30

Completion

2029-04-30

FDA Drug

Yes

Countries

• United States

Study Locations