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Table 1 Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT) schedule of enrollment, interventions, and assessments

From: Stress ulcer prophylaxis versus placebo—a blinded randomized control trial to evaluate the safety of two strategies in critically ill infants with congenital heart disease (SUPPRESS-CHD)

Time point   Study period
Enrollment Allocation Post-allocation Close-out
Pre-study Study day #1 Study day #2 through up to 14 24 h after respiratory support discontinued Hospital discharge
Enrollment Eligibility screen    
Informed consent    
Allocation      
Intervention H2 blocker or placebo     
Assessments Demographics    
Laboratory data    
Antibiotic exposure    
Inotrope and vasoactive use    
Nutritional support    
Gastrointestinal bleeding  
Necrotizing enterocolitis  
Infectious complications  
Adverse event  
Oral, gastric, blood, and urine samples    
Stool samples  
Length of stay     
Mortality