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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