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Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial): study protocol for a randomised controlled trial

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      Abstract

      Background

      Mortality in children remains high in sub-Saharan African hospitals. While antimalarial drugs, antibiotics and other definitive treatments are well understood, the role of emergency care with supportive therapies, such as maintaining normal glucose and electrolyte balances, has been given limited attention. Hypoglycaemia is common in children admitted to hospital in low-income settings. The current definition of hypoglycaemia is a blood glucose level < 2.5 mmol/L in a well-nourished child. Outcomes for these children are poor, with a mortality rate of up to 42%. An increased mortality has also been reported among acutely ill children with low-glycaemia, defined as a blood glucose level of 2.5–5.0 mmol/L. The reason for increased mortality rates is not fully understood. This proposal is for a randomised controlled trial to determine the impact on mortality of a raised treatment cut-off level for paediatric hypoglycaemia.

      Methods

      A total of 1266 severely ill children (age range = 1 month – 5 years) admitted to Queen Elizabeth Central Hospital in Blantyre, Malawi with blood glucose in the range of 2.5–5.0 mmol/L will be randomised into intervention or control groups. The intervention group will be treated with an intravenous bolus of 10% dextrose 5 mL/kg followed by a dextrose infusion in addition to standard care while the control group will receive standard care only. Children will be followed until discharge from hospital or death.

      Discussion

      The first patient was enrolled in December 2016 and the expected trial deadline is January 2019. This study is the first to evaluate the benefits of increased dextrose administration in children presenting to hospital with low-glycaemia. The findings will inform national and international policies and guidelines for the management of children with blood sugar abnormalities.

      Trial registration

      ClinicalTrials.gov, NCT02989675. Registered on 5 December 2016.

      Electronic supplementary material

      The online version of this article (10.1186/s13063-017-2411-8) contains supplementary material, which is available to authorized users.

      Related collections

      Most cited references 21

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      SPIRIT 2013 statement: defining standard protocol items for clinical trials.

      The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
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        Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000.

        Information about the distribution of causes of and time trends for child mortality should be periodically updated. We report the latest estimates of causes of child mortality in 2010 with time trends since 2000. Updated total numbers of deaths in children aged 0-27 days and 1-59 months were applied to the corresponding country-specific distribution of deaths by cause. We did the following to derive the number of deaths in children aged 1-59 months: we used vital registration data for countries with an adequate vital registration system; we applied a multinomial logistic regression model to vital registration data for low-mortality countries without adequate vital registration; we used a similar multinomial logistic regression with verbal autopsy data for high-mortality countries; for India and China, we developed national models. We aggregated country results to generate regional and global estimates. Of 7·6 million deaths in children younger than 5 years in 2010, 64·0% (4·879 million) were attributable to infectious causes and 40·3% (3·072 million) occurred in neonates. Preterm birth complications (14·1%; 1·078 million, uncertainty range [UR] 0·916-1·325), intrapartum-related complications (9·4%; 0·717 million, 0·610-0·876), and sepsis or meningitis (5·2%; 0·393 million, 0·252-0·552) were the leading causes of neonatal death. In older children, pneumonia (14·1%; 1·071 million, 0·977-1·176), diarrhoea (9·9%; 0·751 million, 0·538-1·031), and malaria (7·4%; 0·564 million, 0·432-0·709) claimed the most lives. Despite tremendous efforts to identify relevant data, the causes of only 2·7% (0·205 million) of deaths in children younger than 5 years were medically certified in 2010. Between 2000 and 2010, the global burden of deaths in children younger than 5 years decreased by 2 million, of which pneumonia, measles, and diarrhoea contributed the most to the overall reduction (0·451 million [0·339-0·547], 0·363 million [0·283-0·419], and 0·359 million [0·215-0·476], respectively). However, only tetanus, measles, AIDS, and malaria (in Africa) decreased at an annual rate sufficient to attain the Millennium Development Goal 4. Child survival strategies should direct resources toward the leading causes of child mortality, with attention focusing on infectious and neonatal causes. More rapid decreases from 2010-15 will need accelerated reduction for the most common causes of death, notably pneumonia and preterm birth complications. Continued efforts to gather high-quality data and enhance estimation methods are essential for the improvement of future estimates. The Bill & Melinda Gates Foundation. Copyright © 2012 Elsevier Ltd. All rights reserved.
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          SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

          High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
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            Author and article information

            Affiliations
            [1 ]ISNI 0000 0004 1937 0626, GRID grid.4714.6, Global Health – Health System and Policy Research Group, Department of Public Health Sciences, , Karolinska Institutet, ; 171 77 Stockholm, Sweden
            [2 ]ISNI 0000 0004 0598 3456, GRID grid.415487.b, Department of Anaesthesia & Intensive Care, , Queen Elizabeth Central Hospital, ; Blantyre, Malawi
            [3 ]ISNI 0000 0000 9241 5705, GRID grid.24381.3c, Perioperative Medicine and Intensive Care, , Karolinska Univeristy Hospital, ; Stockholm, Sweden
            [4 ]ISNI 0000 0001 2113 2211, GRID grid.10595.38, Department of Paediatrics, College of Medicine, , University of Malawi, ; Blantyre, Malawi
            [5 ]ISNI 0000 0000 9241 5705, GRID grid.24381.3c, Astrid Lindgren Children’s Hospital, , Karolinska University Hospital, ; Stockholm, Sweden
            Contributors
            Tim.Baker@ki.se
            drdubefirst@yahoo.com
            joelangton@doctors.org.uk
            ORCID: http://orcid.org/0000-0001-7570-9792, Helena.Hildenwall@ki.se
            Journal
            Trials
            Trials
            Trials
            BioMed Central (London )
            1745-6215
            11 January 2018
            11 January 2018
            2018
            : 19
            29325595
            5765642
            2411
            10.1186/s13063-017-2411-8
            © The Author(s). 2018

            Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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.

            Funding
            Funded by: FundRef http://dx.doi.org/10.13039/501100004359, Vetenskapsrådet;
            Award ID: 348-2014-2791
            Award ID: 2016-00230
            Award Recipient :
            Funded by: FundRef http://dx.doi.org/10.13039/501100004348, Stockholms Läns Landsting;
            Categories
            Study Protocol
            Custom metadata
            © The Author(s) 2018

            Medicine

            emergency medicine, paediatrics, critical care, hypoglycaemia

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