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Table 1 SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Schedule of Events Timeline: enrolment, assessment of safety, assessment of efficacy, and dispensing of the medicine

From: Effectiveness of steroids versus placebo in preventing upper airway obstruction after extubation in critically ill children: rationale and design of a multicentric, double-blind, randomized study

TestsScreeningFirst visit prior to extubationVisits
2 to 8
Assessment of eligibility
 Informed consentX  
 Inclusion and exclusion criteriaX  
 AnamnesisX  
Assessment of safety
 Physical examinationXXX
 Vital signsXXX
 Assessment of adverse events XX
 Previous and current medicationsXXX
Assessment of efficacy
 Vital signsXXX
 StridorXXX
 Taussig scaleXXX
 Reintubation XX
Other assessments
 Other medications XX
Deliveries of medication
 Randomization and dispensing of the medication XX
 Contact with the randomized-dispensing centerXXX
  1. Visits 2 to 8, respectively: 15 min, 1 h, 2 h, 6 h, 12 h, 24 h, and 48 h after extubation