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Table 1 Study visit schedule

From: Short course daily prednisolone therapy during an upper respiratory tract infection in children with relapsing steroid-sensitive nephrotic syndrome (PREDNOS 2): protocol for a randomised controlled trial

Visit 1 2 3 4 5
Month 0 3 6 9 12
Visit window   +/-2 weeks +/-2 weeks +/-2 weeks +/-2 weeks
Inclusion/exclusion criteria x     
Informed consent x     
Randomisation (post-recruitment) x     
Allocation of study number x     
Documentation of URTI   x x x x
Documentation of commencement of study drug   x x x x
Documentation of recent relapse x x x x x
Recent medical and drug history x x x x x
Adverse event documentation   x x x x
Compliance check (tablet count using counting triangle)   x x x x
Physical exam x x x x x
Assessment of steroid toxicity x x x x x
Height and weight x x x x x
Blood pressure x x x x  
Calculation of study drug dose to be administered in event of URTI and explanation and provision of documentation of this to parents and guardians – includes review of height, weight and body surface area to confirm correct dose x x x x x
If three or more courses of study drug have been administered since previous visit, confirm parental understanding of definition of URTI   x x x x
Blood sample for DNA/RNAa x x x x x
Achenbach Child Behaviour Checklist x x x x x
PedsQL questionnaire x x x x x
CHU-9D and EQ-5D questionnaires x x x x x
Study drug returned to central pharmacy for accountability      x
  1. aBlood sample to be collected on one single occasion only.
  2. URTI, upper respiratory tract infection.
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