A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adver… (NCT02477423) | Clinical Trial Compass
CompletedNot Applicable
A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
United States27 participantsStarted 2015-07
Plain-language summary
The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.
Who can participate
Age range6 Hours
SexALL
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Inclusion criteria
✓. Infant must be born between the gestational ages of 28 0/7 weeks and 34 6/7 weeks
✓AND-
✓. Infant must be born at investigator's home institution.
✓AND-
✓. Infant must be considered to have a low risk of infection by one of the following criteria:
✓. Delivered for maternal indications (Cesarean section or induction of labor for maternal health, including pre-eclampsia, placental abruption, history of intrauterine fetal demise (IUFD)/abruption, multiple gestation requiring preterm delivery, etc) -OR-
✓. Delivered due to preterm labor to a mother without the diagnosis of chorioamnionitis/maternal fever or prolonged rupture of membranes \>18 hours
Exclusion criteria
✕. Signs of clinical illness within the first 3 hours of life: