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Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial.

ABSTRACT: BACKGROUND:Therapeutic hypothermia reduces death and disability after moderate or severe neonatal encephalopathy in high-income countries and is used as standard therapy in these settings. However, the safety and efficacy of cooling therapy in low- and middle-income countries (LMICs), where 99% of the disease burden occurs, remains unclear. We will examine whether whole body cooling reduces death or neurodisability at 18-22 months after neonatal encephalopathy, in LMICs. METHODS:We will randomly allocate 408 term or near-term babies (aged???6 h) with moderate or severe neonatal encephalopathy admitted to public sector neonatal units in LMIC countries (India, Bangladesh or Sri Lanka), to either usual care alone or whole-body cooling with usual care. Babies allocated to the cooling arm will have core body temperature maintained at 33.5 °C using a servo-controlled cooling device for 72 h, followed by re-warming at 0.5 °C per hour. All babies will have detailed infection screening at the time of recruitment and 3 Telsa cerebral magnetic resonance imaging and spectroscopy at 1-2 weeks after birth. Our primary endpoint is death or moderate or severe disability at the age of 18 months. DISCUSSION:Upon completion, HELIX will be the largest cooling trial in neonatal encephalopathy and will provide a definitive answer regarding the safety and efficacy of cooling therapy for neonatal encephalopathy in LMICs. The trial will also provide important data about the influence of co-existent perinatal infection on the efficacy of hypothermic neuroprotection. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02387385 . Registered on 27 February 2015.

SUBMITTER: Thayyil S

PROVIDER: S-EPMC5604260 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial.

Thayyil Sudhin S Oliveira Vania V Lally Peter J PJ Swamy Ravi R Bassett Paul P Chandrasekaran Mani M Mondkar Jayashree J Mangalabharathi Sundaram S Benkappa Naveen N Seeralar Arasar A Shahidullah Mohammod M Montaldo Paolo P Herberg Jethro J Manerkar Swati S Kumaraswami Kumutha K Kamalaratnam Chinnathambi C Prakash Vinayagam V Chandramohan Rema R Bandya Prathik P Mannan Mohammod Abdul MA Rodrigo Ranmali R Nair Mohandas M Ramji Siddarth S Shankaran Seetha S

Trials 20170918 1

<h4>Background</h4>Therapeutic hypothermia reduces death and disability after moderate or severe neonatal encephalopathy in high-income countries and is used as standard therapy in these settings. However, the safety and efficacy of cooling therapy in low- and middle-income countries (LMICs), where 99% of the disease burden occurs, remains unclear. We will examine whether whole body cooling reduces death or neurodisability at 18-22 months after neonatal encephalopathy, in LMICs.<h4>Methods</h4>W ...[more]

PMID: 28923118

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Project description:BackgroundAlthough therapeutic hypothermia reduces death or disability after neonatal encephalopathy in high-income countries, its safety and efficacy in low-income and middle-income countries is unclear. We aimed to examine whether therapeutic hypothermia alongside optimal supportive intensive care reduces death or moderate or severe disability after neonatal encephalopathy in south Asia.MethodsWe did a multicountry open-label, randomised controlled trial in seven tertiary neonatal intensive care units in India, Sri Lanka, and Bangladesh. We enrolled infants born at or after 36 weeks of gestation with moderate or severe neonatal encephalopathy and a need for continued resuscitation at 5 min of age or an Apgar score of less than 6 at 5 min of age (for babies born in a hospital), or both, or an absence of crying by 5 min of age (for babies born at home). Using a web-based randomisation system, we allocated infants into a group receiving whole body hypothermia (33·5°C) for 72 h using a servo-controlled cooling device, or to usual care (control group), within 6 h of birth. All recruiting sites had facilities for invasive ventilation, cardiovascular support, and access to 3 Tesla MRI scanners and spectroscopy. Masking of the intervention was not possible, but those involved in the magnetic resonance biomarker analysis and neurodevelopmental outcome assessments were masked to the allocation. The primary outcome was a combined endpoint of death or moderate or severe disability at 18-22 months, assessed by the Bayley Scales of Infant and Toddler Development (third edition) and a detailed neurological examination. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT02387385.FindingsWe screened 2296 infants between Aug 15, 2015, and Feb 15, 2019, of whom 576 infants were eligible for inclusion. After exclusions, we recruited 408 eligible infants and we assigned 202 to the hypothermia group and 206 to the control group. Primary outcome data were available for 195 (97%) of the 202 infants in the hypothermia group and 199 (97%) of the 206 control group infants. 98 (50%) infants in the hypothermia group and 94 (47%) infants in the control group died or had a moderate or severe disability (risk ratio 1·06; 95% CI 0·87-1·30; p=0·55). 84 infants (42%) in the hypothermia group and 63 (31%; p=0·022) infants in the control group died, of whom 72 (36%) and 49 (24%; p=0·0087) died during neonatal hospitalisation. Five serious adverse events were reported: three in the hypothermia group (one hospital readmission relating to pneumonia, one septic arthritis, and one suspected venous thrombosis), and two in the control group (one related to desaturations during MRI and other because of endotracheal tube displacement during transport for MRI). No adverse events were considered causally related to the study intervention.InterpretationTherapeutic hypothermia did not reduce the combined outcome of death or disability at 18 months after neonatal encephalopathy in low-income and middle-income countries, but significantly increased death alone. Therapeutic hypothermia should not be offered as treatment for neonatal encephalopathy in low-income and middle-income countries, even when tertiary neonatal intensive care facilities are available.FundingNational Institute for Health Research, Garfield Weston Foundation, and Bill & Melinda Gates Foundation.TranslationsFor the Hindi, Malayalam, Telugu, Kannada, Singhalese, Tamil, Marathi and Bangla translations of the abstract see Supplementary Materials section.

Project description:Summary Background Surgical site infection (SSI) is the most common postoperative complication worldwide. WHO guidelines to prevent SSI recommend alcoholic chlorhexidine skin preparation and fascial closure using triclosan-coated sutures, but called for assessment of both interventions in low-resource settings. This study aimed to test both interventions in low-income and middle-income countries. Methods FALCON was a 2 × 2 factorial, randomised controlled trial stratified by whether surgery was clean-contaminated, or contaminated or dirty, including patients undergoing abdominal surgery with a skin incision of 5 cm or greater. This trial was undertaken in 54 hospitals in seven countries (Benin, Ghana, India, Mexico, Nigeria, Rwanda, and South Africa). Patients were computer randomised 1:1:1:1 to: (1) 2% alcoholic chlorhexidine and non-coated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone–iodine and non-coated suture, or (4) 10% aqueous povidone–iodine and triclosan-coated suture. Patients and outcome assessors were masked to intervention allocation. The primary outcome was SSI, reported by trained outcome assessors, and presented using adjusted relative risks and 95% CIs. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03700749. Findings Between Dec 10, 2018, and Sept 7, 2020, 5788 patients (3091 in clean-contaminated stratum, 2697 in contaminated or dirty stratum) were randomised (1446 to alcoholic chlorhexidine and non-coated suture, 1446 to alcoholic chlorhexidine and triclosan-coated suture, 1447 to aqueous povidone–iodine and non-coated suture, and 1449 to aqueous povidone–iodine and triclosan-coated suture). 14·0% (810/5788) of patients were children and 66·9% (3873/5788) had emergency surgery. The overall SSI rate was 22·0% (1163/5284; clean-contaminated stratum 15·5% [454/2923], contaminated or dirty stratum 30·0% [709/2361]). For both strata, there was no evidence of a difference in the risk of SSI with alcoholic chlorhexidine versus povidone–iodine (clean-contaminated stratum 15·3% [223/1455] vs 15·7% [231/1468], relative risk 0·97 [95% CI 0·82–1·14]; contaminated or dirty stratum 28·3% [338/1194] vs 31·8% [371/1167], relative risk 0·91 [95% CI 0·81–1·02]), or with triclosan-coated sutures versus non-coated sutures (clean-contaminated stratum 14·7% [215/1459] vs 16·3% [239/1464], relative risk 0·90 [95% CI 0·77–1·06]; contaminated or dirty stratum 29·4% [347/1181] vs 30·7% [362/1180], relative risk 0·98 [95% CI 0·87–1·10]). With both strata combined, there were no differences using alcoholic chlorhexidine or triclosan-coated sutures. Interpretation This trial did not show benefit from 2% alcoholic chlorhexidine skin preparation compared with povidone–iodine, or with triclosan-coated sutures compared with non-coated sutures, in preventing SSI in clean-contaminated or contaminated or dirty surgical wounds. Both interventions are more expensive than alternatives, and these findings do not support recommendations for routine use. Funding National Institute for Health Research (NIHR) Global Health Research Unit Grant, BD.

Project description:IntroductionLow-income and middle-income settings like India have large treatment gaps in mental healthcare. People with severe mental disorders face impediments to their clinical and functional recovery, and have large unmet needs. The infrastructure and standards of care are poor in colonial period psychiatric hospitals, with no clear pathways to discharge and successfully integrate recovered individuals into the community. Our aim is to study the impact of psychiatric hospital reform on individual patient outcomes in a psychiatric hospital in India.Methods and analysisStructured Individualised inTervention And Recovery (SITAR) is a two-arm pragmatic randomised controlled trial, focusing on patients aged 18-60 years with a hospital stay of 12-120 months and a primary diagnosis of psychosis. It tests the effectiveness of structural and process reform with and without an individually tailored recovery plan on patient outcomes of disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life. A computer-generated permuted block randomisation schedule will allocate recruited subjects to the two study arms. We aim to recruit 100 people into each trial arm. Baseline and outcome measures will be undertaken by trained researchers independent to the case managers providing the individual intervention. A health economic analysis will determine the costing of implementing the individually tailored recovery plan.Ethics and disseminationThe study will provide answers to important questions around the nature and process of reforms in institutional care that promote recovery while being cognizant of protecting human rights, and dignity. Ethical approval for SITAR was obtained from a registered ethics committee in India (Institutional Ethics Committee VikasAnvesh Foundation, VAF/2018-19/012 dated 6 December 2018) and the University of Warwick's Biomedical and Scientific Research Ethics Committee (REGO-2019-2332, dated 21 March 2019), and registered on the Central Trial Registry of India (CTRI/2019/01/017267). Trial results will be published in accordance to CONSORT guidelines.

Project description:IntroductionHealth-related data collection tools, including digital ones, have become more prevalent across clinical studies in the last number of years. However, using digital data collection tools in low-income and middle-income countries presents unique challenges. In this review, we aim to provide an overview of the data collection tools currently being used in randomised controlled trials (RCTs) conducted in low-resource settings and evaluate the tools based on the characteristics outlined in the modified Mobile Survey Tool framework. These include functionality, reliability, usability, efficiency, maintainability, portability, effectiveness, cost-benefit, satisfaction, freedom from risk and context coverage. This evidence may provide a guide to selecting a suitable data collection tool for researchers planning to conduct research in low-income and middle-income countries for future studies.Methods and analysisSearches will be conducted in four electronic databases: PubMed, CINAHL, Web of Science and EMBASE. For inclusion, studies must be a RCT, mention a health-related data collection tool and conducted in a low- and middle-income country. Only studies with available full-text and written in English will be included. The search was restricted to studies published between January 2005 and June 2023. This systematic review will use the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) tool. Two review authors will screen the titles and abstracts of search results independently for inclusion. In the initial screening process, the full-text articles will be retrieved if the abstract contains limited information about the study. Disagreements will be resolved through discussion. If the disagreement cannot be resolved, a third author (JO'D) will adjudicate. The study selection process will be outlined in a PRISMA flow-diagram. Data will be analysed using a narrative synthesis approach. The included studies and their outcomes will be presented in a table.Ethics and disseminationFormal ethical approval is not required as primary data will not be collected in this study. The findings from this systematic review will be published in a peer-reviewed journal.Prospero registration numberCRD42023405738.

Project description:ObjectiveTo evaluate evidence from published randomised controlled trials (RCTs) for the use of task-shifting strategies for cardiovascular disease (CVD) risk reduction in low-income and middle-income countries (LMICs).DesignSystematic review of RCTs that utilised a task-shifting strategy in the management of CVD in LMICs.Data sourcesWe searched the following databases for relevant RCTs: PubMed from the 1940s, EMBASE from 1974, Global Health from 1910, Ovid Health Star from 1966, Web of Knowledge from 1900, Scopus from 1823, CINAHL from 1937 and RCTs from ClinicalTrials.gov.Eligibility criteria for selecting studiesWe focused on RCTs published in English, but without publication year. We included RCTs in which the intervention used task shifting (non-physician healthcare workers involved in prescribing of medications, treatment and/or medical testing) and non-physician healthcare providers in the management of CV risk factors and diseases (hypertension, diabetes, hyperlipidaemia, stroke, coronary artery disease or heart failure), as well as RCTs that were conducted in LMICs. We excluded studies that are not RCTs.ResultsOf the 2771 articles identified, only three met the predefined criteria. All three trials were conducted in practice-based settings among patients with hypertension (2 studies) and diabetes (1 study), with one study also incorporating home visits. The duration of the studies ranged from 3 to 12 months, and the task-shifting strategies included provision of medication prescriptions by nurses, community health workers and pharmacists and telephone follow-up posthospital discharge. Both hypertension studies reported a significant mean blood pressure reduction (2/1 mm Hg and 30/15 mm Hg), and the diabetes trial reported a reduction in the glycated haemoglobin levels of 1.87%.ConclusionsThere is a dearth of evidence on the implementation of task-shifting strategies to reduce the burden of CVD in LMICs. Effective task-shifting interventions targeted at reducing the global CVD epidemic in LMICs are urgently needed.

Project description:IntroductionGlobally, transgender and other gender diverse (trans) people face pervasive stigma, which contributes to health inequities across multiple health outcomes. Stigma is a fundamental cause of health inequities because it simultaneously limits access to resources, contributes to systemic vulnerability and generates chronic stress. Anti-trans stigma occurs across multiple socioecological levels, resulting in multiple possible definitions and measurements of trans stigma. Understanding how trans stigma has been measured in low-income and middle-income countries (LMICs) is critical to health promotion efforts for trans communities. Accordingly, this scoping review will identify and examine how anti-trans stigma has been measured in existing LMIC-specific research to inform best practices for measurement of anti-trans stigma that includes consideration of local context.Methods and analysisThis is the protocol for a scoping review of anti-trans stigma in LMICs. We will search (from January 2001 to December 2021) PubMed, WHO Global Medicus and EBSCO. Study selection will conform to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews Checklist. Original studies in English, Spanish, Arabic or Russian will be included. Reviewers will independently screen all citations, full-text articles and abstract data. Data analysis will involve quantitative and qualitative methods. A narrative summary of findings will be conducted.Ethics and disseminationAs a scoping review (no direct interaction with participants), this study is exempt from human subjects oversight. Understanding context-specific ways to measure anti-trans stigma is urgently needed to support trans health globally. The planned scoping review will help to address this gap. Results of the review will be disseminated in a peer-reviewed journal and likely in other media such as conferences, seminars and symposia. PROTOCOL REGISTRATION NUMBER: osf.io/qcs2v.

Dataset Information

Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial.

Publications

Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial.

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