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Evaluation of Daily Low-Dose Prednisolone During Upper Respiratory Tract Infection to Prevent Relapse in Children With Relapsing Steroid-Sensitive Nephrotic Syndrome: The PREDNOS 2 Randomized Clinical Trial.
Christian, Martin T; Webb, Nicholas J A; Mehta, Samir; Woolley, Rebecca L; Afentou, Nafsika; 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; Prajapati, Hitesh; Gilbert, Rodney D; Jones, Caroline; McKeever, Karl; Cook, Wendy; Ives, Natalie.
Afiliação
  • Christian MT; Department of Paediatric Nephrology, Nottingham Children's Hospital, Nottingham, UK.
  • Webb NJA; Department of Paediatric Nephrology, University of Manchester, Manchester Academic Health Science Centre, Royal Manchester Children's Hospital, Manchester, UK.
  • Mehta S; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
  • Woolley RL; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
  • Afentou N; Health Economics Unit, University of Birmingham, Birmingham, UK.
  • Frew E; Health Economics Unit, University of Birmingham, Birmingham, UK.
  • Brettell EA; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
  • Khan AR; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
  • Milford DV; Department of Paediatric Nephrology, Birmingham Children's Hospital, Birmingham, UK.
  • Bockenhauer D; Department of Renal Medicine, University College London, London, UK.
  • Saleem MA; Department of Paediatric Nephrology, Great Ormond Street Hospital for Children, London, UK.
  • Hall AS; Department of Glomerular Cell Biology, Bristol Medical School, University of Bristol, Bristol, UK.
  • Koziell A; Department of Paediatric Nephrology, Bristol Royal Hospital for Children, Bristol, UK.
  • Maxwell H; Leicester Children's Hospital, Leicester, UK.
  • Hegde S; Child Health Clinical Academic Group, King's College London, London, UK.
  • Prajapati H; Department of Paediatric Nephrology, Evelina Children's Hospital, London, UK.
  • Gilbert RD; Department of Paediatric Nephrology, Royal Hospital for Sick Children, Glasgow, UK.
  • Jones C; Department of Paediatric Nephrology, University Hospital of Wales, Cardiff, UK.
  • McKeever K; Department of Paediatric Nephrology, Leeds Children's Hospital, Leeds, UK.
  • Cook W; Department of Paediatric Nephrology, Southampton Children's Hospital, Southampton, UK.
  • Ives N; Department of Paediatric Nephrology, Alder Hey Children's Hospital, Liverpool, UK.
JAMA Pediatr ; 176(3): 236-243, 2022 Mar 01.
Article em En | MEDLINE | ID: mdl-34928294
IMPORTANCE: In children with corticosteroid-sensitive nephrotic syndrome, many relapses are triggered by upper respiratory tract infections. Four small studies found that administration of daily low-dose prednisolone for 5 to 7 days at the time of an upper respiratory tract infection reduced the risk of relapse, but the generalizability of their findings is limited by location of the studies and selection of study population. OBJECTIVE: To investigate the use of daily low-dose prednisolone for the treatment of upper respiratory tract infection-related relapses. DESIGN, SETTING, AND PARTICIPANTS: This double-blind, placebo-controlled randomized clinical trial (Prednisolone in Nephrotic Syndrome [PREDNOS] 2) evaluated 365 children with relapsing steroid-sensitive nephrotic syndrome with and without background immunosuppressive treatment at 122 pediatric departments in the UK from February 1, 2013, to January 31, 2020. Data from the modified intention-to-treat population were analyzed from July 1, 2020, to December 31, 2020. INTERVENTIONS: At the start of an upper respiratory tract infection, children received 6 days of prednisolone, 15 mg/m2 daily, or matching placebo preparation. Those already taking alternate-day prednisolone rounded their daily dose using trial medication to the equivalent of 15 mg/m2 daily or their alternate-day dose, whichever was greater. MAIN OUTCOMES AND MEASURES: The primary outcome was the incidence of first upper respiratory tract infection-related relapse. Secondary outcomes included overall rate of relapse, changes in background immunosuppressive treatment, cumulative dose of prednisolone, rates of serious adverse events, incidence of corticosteroid adverse effects, and quality of life. RESULTS: The modified intention-to-treat analysis population comprised 271 children (mean [SD] age, 7.6 [3.5] years; 174 [64.2%] male), with 134 in the prednisolone arm and 137 in the placebo arm. The number of patients experiencing an upper respiratory tract infection-related relapse was 56 of 131 (42.7%) in the prednisolone arm and 58 of 131 (44.3%) in the placebo arm (adjusted risk difference, -0.02; 95% CI, -0.14 to 0.10; P = .70). No evidence was found that the treatment effect differed according to background immunosuppressive treatment. No significant differences were found in secondary outcomes between the treatment arms. A post hoc subgroup analysis assessing the primary outcome in 54 children of South Asian ethnicity (risk ratio, 0.66; 95% CI, 0.40-1.10) vs 208 children of other ethnicity (risk ratio, 1.11; 95% CI, 0.81-1.54) found no difference in efficacy of intervention in those of South Asian ethnicity (test for interaction P = .09). CONCLUSIONS AND RELEVANCE: The results of PREDNOS 2 suggest that administering 6 days of daily low-dose prednisolone at the time of an upper respiratory tract infection does not reduce the risk of relapse of nephrotic syndrome in children in the UK. Further work is needed to investigate interethnic differences in treatment response. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN10900733; EudraCT 2012-003476-39.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Infecções Respiratórias / Síndrome Nefrótica Tipo de estudo: Clinical_trials / Diagnostic_studies / Prognostic_studies Limite: Child / Humans / Male Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Infecções Respiratórias / Síndrome Nefrótica Tipo de estudo: Clinical_trials / Diagnostic_studies / Prognostic_studies Limite: Child / Humans / Male Idioma: En Ano de publicação: 2022 Tipo de documento: Article