Skip to main content

Table 1 Trial schedule procedures

From: Use of probiotics to reduce infections and death and prevent colonization with extended-spectrum beta-lactamase (ESBL)-producing bacteria among newborn infants in Tanzania (ProRIDE Trial): study protocol for a randomized controlled clinical trial

Study period
  Enrolment Allocation Post-allocation
Timepoint Screening Baseline 7 days* 6 weeks 6 months
 Informed consent mother/caretaker x     
 Eligibility screening newborn   x    
 Randomization newborn   x    
 Probiotics   x x   
 Placebo   x x   
 Rates of confirmed sepsis episodes     x x
 Rates of hospitalization     x x
 Growth by height and weight     x x
 Stool microbiota composition and resistome     x x
 Stool metabolome composition     x x
 Stool inflammatory markers      x
 Genetic characteristics of ESBL-E and other MDR isolates     x x
 Prevalence ESBL-E carriage     x x
  1. Abbreviations: ESBL-E extended-spectrum beta-lactamase Enterobacteriaceae, MDR multidrug resistant
  2. *Observe for adherence and discuss issues with care takers