Vaginal Microbiome Exposure and Immune Responses in C-section Infants

EARLY_PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

November 28, 2018

Primary Completion Date

January 30, 2025

Study Completion Date

January 31, 2027

Conditions
Allergic DiseasesAsthma
Interventions
BIOLOGICAL

C-section -Vaginal seeding

"Mother-infant pair randomized to vaginal microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the vaginal microbiota soaked gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding procedure once.~Additional Intervention:~Following the seeding procedure, infants will then receive the standard detailed examination for newborns and standard of care, except that the first infant bath will occur at least 12 hours after delivery."

DRUG

C-section - Placebo Seeding

"Mother-infant pair randomized to placebo microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the placebo gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding procedure once.~Additional Intervention:~Following the seeding procedure, infants will then receive the standard detailed examination for newborns and standard of care, except that the first infant bath will occur at least 12 hours after delivery."

OTHER

Standard care

Mother-infant pair where mother undergoes spontaneous vaginal delivery, with both receiving standard of care.

Trial Locations (2)

10019

Mount Sinai West, New York

10029

Icahn School of Medicine at Mount Sinai, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Immune Tolerance Network (ITN)

NETWORK

collaborator

PPD Development, LP

INDUSTRY

collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03567707 - Vaginal Microbiome Exposure and Immune Responses in C-section Infants | Biotech Hunter | Biotech Hunter