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

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

Tests	Screening	First visit prior to extubation	Visits 2 to 8
Assessment of eligibility
Informed consent	X
Inclusion and exclusion criteria	X
Anamnesis	X
Assessment of safety
Physical examination	X	X	X
Vital signs	X	X	X
Assessment of adverse events		X	X
Previous and current medications	X	X	X
Assessment of efficacy
Vital signs	X	X	X
Stridor	X	X	X
Taussig scale	X	X	X
Reintubation		X	X
Other assessments
Other medications		X	X
Deliveries of medication
Randomization and dispensing of the medication		X	X
Contact with the randomized-dispensing center	X	X	X

Visits 2 to 8, respectively: 15 min, 1 h, 2 h, 6 h, 12 h, 24 h, and 48 h after extubation

ISSN: 1745-6215