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Table 2 Procedures and intervention in the RCT

From: Study protocol: DexaDays-2, hydrocortisone for treatment of dexamethasone-induced neurobehavioral side effects in pediatric leukemia patients: a double-blind placebo controlled randomized intervention study with cross-over design

Day

1 / 43

2 / 44

3 / 45

4 / 46

5 / 47

6 / 48

7 / 49

22 / 64

23 /

24 /

25 /

26 /

27 / 69

85

Timepoint Procedure

T3/T7

    

T4/T8

 

T5/T9

65

66

67

68

T6/T10

T11

Standard medication

 Dexamethasone

X

X

X

X

X

  

X

X

X

X

X

 

X

 Vincristine

X

      

X

     

X

 Methotrexate

X

      

X

     

X

Study medication

 Hydrocortisone or placebo

X

X

X

X

X

  

X

X

X

X

X

  

Questionnaires

 SDQ

X

    

X

 

X

    

X

X

 SDSC

X

    

X

        

 PedsQL generic

X

    

X

        

 DT (short)

X

    

X

        

 Eating thermometer

X

    

X

        

Sleep diary

X

X

X

X

X

X

X

       

Actigraphy

X

X

X

X

X

X

X

       

Somatic parameters

 Weight

X

    

X

 

X

     

X

 Height

X

    

X

 

X

     

X

 Blood pressure

X

      

X

     

X

Done at (h = home / H = hospital)

H

h

h

h

h

h

h

H

h

h

h

h

h

H

  1. T3/T7 & T5/T9 = start of dexamethasone and study medication. T4/T8 & T6/T10 = after 5 days of dexamethasone and study medication. T11 = closing visit. See Fig. 1 for a schematic overview
  2. RCT Randomized controlled trial, SDQ Strengths and difficulties questionnaire, SDSC Sleep disturbance scale for children, PedsQL Pediatric quality of life questionnaire, DT Distress thermometer
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BMC Pediatrics

ISSN: 1471-2431

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