Single vs split dose of prednisolone in the treatment relapses of childhood nephrotic syndrome: A Randomized Controlled Trial

Category Primary study
Registry of TrialsSLCTR
Year 2019
INTERVENTION: 1. Study setting The paediatric nephrology section of the Professorial Paediatric Unit at Teaching Hospital Peradeniya 2. Method of randomization Block randomization. Study group and control. Each arm of the study will contain 4 blocks that are randomly selected utilizing random number generator software. (1‐4,4‐7,7‐10,10‐14) according to the age and the sample size will be 60 per group 3. Intervention Patients randomized to Group A will be given oral prednisolne at 60mg/m2 (dose rounded off to the nearest 5mg) as a single morning dose, while Group B will be given the same total dose as two divided doses, of which 2/3 will be given in the morning and the rest in the evening (all doses rounded up to the nearest 5mg). This will be continued until remission is achieved (nil or trace proteinuria for 3 consecutive days) following which all patients will be switched to alternate day prednisolne at 60mg/m2 which will be given as a single morning dose. Crushing of tablet may be done by a nursing officer when required for some paediatric patients. CONDITION: Nephrotic syndrome PRIMARY OUTCOME: Remission is defined as a urine test with nil or trace proteinuria for 3 consecutive days. ; Urine albumin test will be checked every day only from early morning urine sample for assessment of remission; ; Number of days until a remission will be used to compare the test group and the control group; [Daily urine analysis and date of remission (for number of days for remission after introducing the intervention) ]; SECONDARY OUTCOME: Proportion of patients on second line medicine/s who achieved remissions in < 5 days ; ; Proportion of patients not on second line medicine/s who achieved remissions in < 5 days [At study completion]; INCLUSION CRITERIA: • Male and female • Between 1 and 14 years of age • With idiopathic nephrotic syndrome • Admitted to the unit with a relapse
Epistemonikos ID: dbbab8b75565ac7519dc3ff0fd48d333a051e689
First added on: Aug 24, 2024