Evidence map›Paper›PMID 24767719›Full record

Trial reportTrials2014

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.

Nicholas J A Webb, Emma Frew, Elizabeth A Brettell, David V Milford, Detlef Bockenhauer, Moin A Saleem, Martin Christian, Angela S Hall, Ania Koziell, Heather Maxwell and 9 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 4 pooled it
2.3field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 4 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Corticosteroid therapy for nephrotic syndrome in children.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Guideline
  3. Corticosteroid therapy for nephrotic syndrome in children.The Cochrane database of systematic reviews · 2020
    Pooled it
  4. Corticosteroid therapy for nephrotic syndrome in children.The Cochrane database of systematic reviews · 2015
    Pooled it
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. The non-immunosuppressive management of childhood nephrotic syndrome.Pediatric nephrology (Berlin, Germany) · 2016
    Review
  14. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 12 institutions in 1 country.

Nicholas J A WebbDepartment of Paediatric Nephrology and NIHR/Wellcome Trust Children's Clinical Research Facility, University of Manchester, Manchester Academic Health Science Centre, Royal Manchester Children's Hospital, Manchester, UK. nicholas.webb@cmft.nhs.uk.
Emma Frew
Elizabeth A Brettell
David V Milford
Detlef Bockenhauer
Moin A Saleem
Martin Christian
Angela S Hall
Ania Koziell
Heather Maxwell
Shivram Hegde
Eric R Finlay
Rodney D Gilbert
Jenny Booth
Caroline Jones
Karl McKeever
Wendy Cook
Natalie J Ives
PREDNOS 2 study group
National Institute for Health Research · GBUniversity of Birmingham · GBAlder Hey Children's Hospital · GBBirmingham Children's Hospital · GBCancer Research UK Clinical Trials Unit · GBEvelina London Children's Healthcare · GBGreat Ormond Street Hospital · GBLeeds Teaching Hospitals NHS Trust · GBManchester Academic Health Science Centre · GBNIHR Southampton Biomedical Research Centre · GBRoyal Belfast Hospital for Sick Children · GBUniversity Hospital of Wales · GB

Funding

Department of Health 11/129/261
6 · The paper itself

Abstract

backgroundRelapses of childhood steroid-sensitive nephrotic syndrome (SSNS) are treated with a 4- to 8-week course of high-dose oral prednisolone, which may be associated with significant adverse effects. There is a clear association between upper respiratory tract infection (URTI) and relapse development. Previous studies in developing nations have suggested that introducing a 5- to 7-day course of daily prednisolone during an URTI may prevent a relapse developing and the need for a treatment course of high-dose prednisolone. The aim of PREDNOS 2 is to evaluate the effectiveness of a 6-day course of daily prednisolone therapy during an URTI in reducing the development of a subsequent relapse in a developed nation. METHODS/

designThe subjects will be 300 children with relapsing SSNS (≥2 relapses in preceding year), who will be randomised to receive either a 6-day course of daily prednisolone or no change to their current therapy (with the use of placebo to double blind) each time they develop an URTI over 12 months. A strict definition for URTI will be used. Subjects will be reviewed at 3, 6, 9 and 12 months to capture data regarding relapse history, ongoing therapy and adverse effect profile, including behavioural problems and quality of life. A formal health economic analysis will also be performed. The primary end point of the study will be the incidence of URTI-related relapse (3 days of Albustix +++) following the first infection during the 12-month follow-up period. DNA and RNA samples will be collected to identify a potential genetic cause for the disease. Subjects will be recruited from over 100 UK centres with the assistance of the Medicines for Children Research Network.PREDNOS 2 is funded by the National Institute for Health Research Health Technology Assessment Programme (11/129/261). DISCUSSION: We propose that PREDNOS 2 will be a pivotal study that will inform the future standard of care for children with SSNS. If it is possible to reduce the disease relapse rate effectively and safely, this will reduce the morbidity and cost associated with drug treatment, notwithstanding hospital admission and parental absence from employment.

trial registrationCurrent Controlled Trials (ISRCTN10900733).

Indexed as

Research DesignAdolescentChildChild, PreschoolClinical ProtocolsCost-Benefit AnalysisDouble-Blind MethodDrug Administration ScheduleDrug CostsGlucocorticoidsHumansNephrotic SyndromePrednisoloneRecurrenceRespiratory Tract InfectionsTime FactorsGlucocorticoidsPrednisolone

Identifiers

PMID24767719
PMCPMC4030532
OpenAlexW2144487897

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.