114
Participants
Start Date
November 28, 2018
Primary Completion Date
January 30, 2025
Study Completion Date
January 31, 2027
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."
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."
Standard care
Mother-infant pair where mother undergoes spontaneous vaginal delivery, with both receiving standard of care.
Mount Sinai West, New York
Icahn School of Medicine at Mount Sinai, New York
Collaborators (1)
Immune Tolerance Network (ITN)
NETWORK
PPD Development, LP
INDUSTRY
Rho Federal Systems Division, Inc.
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH