TIMEPOINT | STUDY PERIOD | |||||||
---|---|---|---|---|---|---|---|---|
Prenatal enrollment | Postnatal enrollment | Allocation | Post-allocation | Close-out | ||||
 |  | 4 h after delivery | 2 h | 24 h | 36 h | 48 h | >48 h | |
ENROLLMENT: | Â | Â | Â | Â | Â | Â | Â | Â |
Eligibility screen | X | X | Â | Â | Â | Â | Â | Â |
Informed consent | X | X | Â | Â | Â | Â | Â | Â |
Allocation | Â | Â | X | Â | Â | Â | Â | Â |
Study drug administration | Â | Â | Â | X | X | X | X | Â |
INTERVENTIONS: | ||||||||
 Empiric antibiotics |  |  |  | X | X | X | X |  |
 Placebo |  |  |  | X | X | X | X |  |
 Rescue antibiotics |  |  |  | * | * | * | * |  |
ASSESSMENTS: | ||||||||
 Demographic variables | X | X | X |  |  |  |  |  |
 Incidence of NEC, LOS, death |  |  | X | X | X | X | X | X |
 Infant fecal samples |  |  |  |  | X |  |  | X |
 Infant blood sample |  |  |  |  | X |  |  |  |
 Maternal fecal samples |  |  |  |  | X |  |  |  |
 Maternal vaginal swab |  |  |  |  | X |  |  |  |
 Infant weight and length measurements |  |  |  |  | X |  |  | X |