| Title: |
Daily low-dose prednisolone to prevent relapse of steroid-sensitive nephrotic syndrome in children with an upper respiratory tract infection: PREDNOS2 RCT |
| Authors: |
Christian, Martin T; Webb, Nicholas Ja; Woolley, Rebecca L; Afentou, Nafsika; Mehta, Samir; Frew, Emma; Brettell, Elizabeth A; Khan, Adam R; Milford, David V; Bockenhauer, Detlef; Saleem, Moin A; Hall, Angela S; Koziell, Ania; Maxwell, Heather; Hegde, Shivaram; Finlay, Eric R; Gilbert, Rodney D; Jones, Caroline; McKeever, Karl; Cook, Wendy; Ives, Natalie |
| Source: |
Health Technology Assessment , 26 (3) pp. 1-94. (2022) |
| Publisher Information: |
National Institute for Health Research |
| Publication Year: |
2022 |
| Collection: |
University College London: UCL Discovery |
| Description: |
BACKGROUND: Most children with steroid-sensitive nephrotic syndrome have relapses that are triggered by upper respiratory tract infections. Four small trials, mostly in children already taking maintenance corticosteroid in countries of different upper respiratory tract infection epidemiology, showed that giving daily low-dose prednisone/prednisolone for 5-7 days during an upper respiratory tract infection reduces the risk of relapse. OBJECTIVES: To determine if these findings were replicated in a large UK population of children with relapsing steroid-sensitive nephrotic syndrome on different background medication or none. DESIGN: A randomised double-blind placebo-controlled trial, including a cost-effectiveness analysis. SETTING: A total of 122 UK paediatric departments, of which 91 recruited patients. PARTICIPANTS: A total of 365 children with relapsing steroid-sensitive nephrotic syndrome (mean age 7.6 ± 3.5 years) were randomised (1 : 1) according to a minimisation algorithm based on background treatment. Eighty children completed 12 months of follow-up without an upper respiratory tract infection. Thirty-two children were withdrawn from the trial (14 prior to an upper respiratory tract infection), leaving a modified intention-to-treat analysis population of 271 children (134 and 137 children in the prednisolone and placebo arms, respectively). INTERVENTIONS: At the start of an upper respiratory tract infection, children received 6 days of prednisolone (15 mg/m2) or an equivalent dose of placebo. MAIN OUTCOME MEASURES: The primary outcome was the incidence of first upper respiratory tract infection-related relapse following any upper respiratory tract infection over 12 months. The secondary outcomes were the overall rate of relapse, changes in background treatment, cumulative dose of prednisolone, rates of serious adverse events, incidence of corticosteroid adverse effects, change in Achenbach Child Behaviour Checklist score and quality of life. Analysis was by intention-to-treat principle. The ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| Relation: |
https://discovery.ucl.ac.uk/id/eprint/10142810/1/3038459.pdf; https://discovery.ucl.ac.uk/id/eprint/10142810/ |
| Availability: |
https://discovery.ucl.ac.uk/id/eprint/10142810/1/3038459.pdf; https://discovery.ucl.ac.uk/id/eprint/10142810/ |
| Rights: |
open |
| Accession Number: |
edsbas.DD006ABC |
| Database: |
BASE |