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

Description

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

Study Overview

Study Details

Study overview

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.

Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates: a Randomized Controlled Trial

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

Condition
Cesarean Delivery Affecting Newborn
Intervention / Treatment

-

Contacts and Locations

Falls Church

Inova Health System, Falls Church, Virginia, United States, 22042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    0 Days to 50 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    Yes

    Collaborators and Investigators

    National Institute of Allergy and Infectious Diseases (NIAID),

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

    Noel Mueller, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

    Maria Gloria Dominguez Bello, PhD, PRINCIPAL_INVESTIGATOR, Rutgers University

    Lawrence Appel, MD, MPH, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

    Study Record Dates

    2029-04