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      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

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          Abstract

          Background

          Relapses 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/design

          The 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 registration

          Current Controlled Trials (ISRCTN10900733).

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          Most cited references 4

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          Time trends and ethnic patterns of childhood nephrotic syndrome in Yorkshire, UK.

          Against the background of the increasing incidence of many immune mediated childhood conditions, this study aimed to identify recent time trends and ethnic patterns of childhood nephrotic syndrome. A population-based cohort of children (0-15 years) diagnosed according to strict criteria with nephrotic syndrome (NS) was ascertained within the northern UK region of Yorkshire between 1987 and 1998. South Asian ethnicity was assigned based on the child's full name using a dedicated computer algorithm and expert individual checks. NS was diagnosed in 194 children, 170 (88%) of whom were steroid sensitive. The incidence of steroid sensitive NS was 2.0/100,000 pyrs (95% CI 1.7-2.3), peaking in 1-4 year olds (4.1/100,000 pyrs). Over the 12-year study period incidence rates of steroid sensitive NS were fairly stable although south Asian children displayed significantly higher rates than non-south Asians (P<0.01). The size of our population-based series reflects the relative rarity of paediatric nephrotic syndrome but is nonetheless recent and includes larger numbers than previous reports. The absence of any increase in incidence over the last decade contrasts with other paediatric immune mediated conditions such as asthma and diabetes.
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            Long-term outcome for children with minimal-change nephrotic syndrome.

            A retrospective study was undertaken to assess the outcome of a cohort of 183 unselected children who presented with the nephrotic syndrome between 1963 and 1969. All subjects showed minimal glomerular changes in biopsy samples and were given conventional steroid therapy. Information was available on 152 children, now aged 14-32 years. Activity persisted longer in patients presenting at an early age. The outcome for most of the children was favourable. Only 10 patients (5.5%), all of whom presented with initial symptoms before their 6th birthday, continued to have steroid-responsive relapses in adult life. There were 11 deaths, of which 7 (4% of the series) were from avoidable complications of the disorder.
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              The effects of corticosteroids on behavior in children with nephrotic syndrome.

              The objective of this study was to measure the frequency and severity of the behavioral effects of high-dose oral steroid therapy in children with nephrotic syndrome. We conducted a prospective assessment of the behavior of 12 children using a standardized psychological questionnaire at the time of diagnosis and again after 4 weeks of steroid therapy. A group of control children was also assessed. There was a significant increase in the total behavior score ( P=0.03) and specifically in aggressive and poor attention behavior items in the group of nephrotic children compared with the control group. Four of the children with nephrotic syndrome developed abnormal behavior in the clinical range compared with none of the controls. In conclusion, children with nephrotic syndrome treated with high-dose oral steroids are at risk of developing clinically relevant behavioral changes.
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                Author and article information

                Contributors
                Journal
                Trials
                Trials
                Trials
                BioMed Central
                1745-6215
                2014
                27 April 2014
                : 15
                : 147
                Affiliations
                [1 ]Department 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
                [2 ]Health Economics Unit, University of Birmingham, Birmingham, UK
                [3 ]Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK
                [4 ]Department of Paediatric Nephrology, Birmingham Children’s Hospital, Birmingham, UK
                [5 ]Department of Paediatric Nephrology, Great Ormond Street Hospital, London, UK
                [6 ]Children’s and Academic Renal Unit, University of Bristol, Bristol, UK
                [7 ]Department of Paediatric Nephrology, Nottingham Children’s Hospital, Nottingham, UK
                [8 ]Children’s Hospital, University Hospitals of Leicester, Leicester, UK
                [9 ]Department of Paediatric Nephrology, Evelina Children’s Hospital, London, UK
                [10 ]Renal Unit, Royal Hospital for Sick Children, Glasgow, UK
                [11 ]Children's Kidney Centre, University Hospital of Wales, Cardiff, UK
                [12 ]Department of Paediatric Nephrology, Leeds Children’s Hospital, Leeds, UK
                [13 ]Department of Paediatric Nephrology, University Hospital Southampton, Southampton, UK
                [14 ]Department of Paediatric Nephrology, Great North Children’s Hospital, Newcastle upon Tyne, UK
                [15 ]Department of Paediatric Nephrology, Alder Hey Children’s Hospital, Liverpool, UK
                [16 ]Department of Paediatric Nephrology, Royal Belfast Hospital for Sick Children, Belfast, UK
                [17 ]Nephrotic Syndrome Trust, Bristol, UK
                [18 ]National Institute for Health Research Medicines for Children Research Network Nephrology Clinical Studies Group, UK
                Author notes
                On behalf of the PREDNOS 2 study group
                Article
                1745-6215-15-147
                10.1186/1745-6215-15-147
                4030532
                24767719
                Copyright © 2014 Webb et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Categories
                Study Protocol

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