Restoration of Microbiota in Neonates - a Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The aim of the study is to examine the effect of exposure of cesarean section (CS) delivered neonates to a natural condition of birth, i.e. to the microbiota of the birth canal, on the acquisition of microbial genes during development of the microbiome at multiple body sites, immune system maturation and allergy risk in childhood
Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: Newborn
Healthy Volunteers: f
View:
• Infants of healthy mothers with uncomplicated pregnancies at term, mothers of any ethnic or social background that can speak, read, and understand Swedish to the extent that they can consent in Swedish. An additional inclusion criterion for mothers in the CS groups is vaginal pH ≤ 4 at the time of birth.
Locations
Other Locations
Sweden
Karolinska Institutet
RECRUITING
Stockholm
Contact Information
Primary
Lars G Engstrand, MD
lars.engstrand@ki.se
+46706780318
Backup
Marica C Hamsten, MSc
marica.hamsten@ki.se
+46675555872
Time Frame
Start Date: 2019-01-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 300
Treatments
No_intervention: vaginally delivered
A non-randomized reference group of vaginally delivered infants.
Active_comparator: CS intervention
A piece of gauze soaked with saline (0.9%) will be placed in the birth canal 2 hours before the CS by the study midwife, using sterile glows. Before the CS procedure begins, the gauze will be removed from the vagina and then immediately contaminated by a swab carrying maternal fecal microbiota. The swab is contaminated by introducing it 3 cm into the anal canal and by rotating it for 10-20 s.~Immediately after birth, the study midwife will swab the neonate with the gauze in multiple body sites by a standardized manner and then swab maternal breasts and chest skin. The neonate will then be placed on the maternal chest to initiate breast-feeding.
Placebo_comparator: CS placebo
See above - the gauze will be exchanged to a clean gauze (soaked with saline). Immediately after birth, the study midwife will swab the neonate with the gauze in multiple body sites by a standardized manner and then swab maternal breasts and chest skin. The neonate will then be placed on the maternal chest to initiate breast-feeding.
Related Therapeutic Areas
Sponsors
Collaborators: Linkoeping University, Umeå University, Uppsala University, Jonkoping University, Örebro University, Sweden
Leads: Karolinska Institutet