The effects of ventilation tubes versus no ventilation tubes for recurrent acute otitis media or chronic otitis media with effusion in 9 to 36 month old Greenlandic children, the SIUTIT trial: study protocol for a randomized controlled trial

Table 1 Participant timeline, Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram

	Study period
Time point	Enrolment	Allocation				Close-out
Enrolment:	−t ₁	0	t ₁	t ₁ + 3 months	t ₁ + 1 year	t ₁ + 2 years
Eligibility screen	X
Informed consent	X
Allocation	X
Interventions:		X
Ventilation tube insertion			X		X
No ventilation tube insertion			X		X
Assessments:
Sex, age, ethnicity, socioeconomic factors	X
Number of visits to health clinic						X
Questionnaires: Otitis Media-6 and Caregiver impact		X	X	X	X	X
Safety variables						X

ISSN: 1745-6215