Effect of community-based behaviour change management on neonatal mortality in Shivgarh, Uttar Pradesh, India: a cluster-randomised controlled trial

Kumar, Vishwajeet; Mohanty, S.; Kumar, Aarti; Misra, R; Santosham, Mathuram; Awasthi, Sanjay; Baqui, Abdullah H; Singh, Pramod Kumar; Singh, Vivek; Ahuja, Ramesh C.; Singh, Jai Vir; Malik, G. K.; Ahmed, Saifuddin; Black, Robert E.; Bhandari, Mahendra; Darmstadt, Gary L.

doi:10.1016/s0140-6736(08)61483-x

Cited by 432 publications

(544 citation statements)

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“…To date, in program design and intervention research, operational definitions of birth preparedness have varied widely, with some such interventions focused primarily on preparations for any delivery (normal or complicated) and other interventions focusing primarily on readiness for both maternal and newborn complications. Research and evaluations related to BP/CR interventions have yielded mixed evidence on the efficacy of such interventions; while some studies have indicated that BP/CR interventions are effective in increasing use of skilled delivery care (Magoma et al, 2013), others-and particularly studies of interventions that focused primarily on complications readiness-have not shown any positive association with institutional delivery (Kumar et al, 2008;McPherson et al, 2006). Nonetheless, many researchers call for increased attention to educating pregnant women about obstetric risks and danger signs in order to increase their use of skilled maternity care and to prevent delays in careseeking for complications (Ekabua et al, 2011, Hailu et al, 2011, Kabakyenga et al, 2012Kakaire et al, 2011;Mutiso et al, 2008).…”

Section: Discussionmentioning

confidence: 99%

“…Evidence on the association between BP/CR and women's care-seeking during childbirth from other research, however, is inconclusive. The results of other intervention studies, which used measures of BP/CR such as women's knowledge about danger signs/risks, their use of antenatal care during pregnancy, and their preparation for newborn care and items for the newborn, showed that there was weak or no association between BP/CR interventions and women's use of skilled maternity care (Kumar et al, 2008;McPherson et al, 2006;Mullany et al, 2007).…”

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confidence: 99%

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Rethinking How to Promote Maternity Care-Seeking: Factors Associated With Institutional Delivery in Guinea

Brazier¹,

Fiorentino²,

Barry³

et al. 2014

Health Care for Women International

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Rethinking How to Promote Maternity Care-Seeking: Factors Associated With Institutional Delivery in Guinea

Brazier¹,

Fiorentino²,

Barry³

et al. 2014

Health Care for Women International

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“…Data on impact of the device on care practices in rural India is forthcoming. 87 Another variant of liquid crystal thermometry is in the form of a calibrated reusable strip that allows visual recognition of temperature in 1 1C gradations between 30 and 41 1C. 73 Prevention and management of hypothermia Many of the warming technologies that are routinely used in highresource settings, including incubators, cannot be feasibly adapted to settings that are without reliable infrastructure or power sources.…”

Section: Recognition Of Hypothermia Measurement and Detectionmentioning

confidence: 99%

Neonatal hypothermia in low resource settings: a review

et al. 2009

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Background: Hypothermia is increasingly recognized as a major cause of neonatal morbidity and mortality in resource poor settings. High prevalence of hypothermia has been reported widely from warmer high mortality regions of Africa and South Asia. The World Health Organization recognizes newborn thermal care as a critical and essential component of essential newborn care; however, hypothermia continues to remain under-documented, under-recognized and under-managed.Objective: This review aims to provide a thorough patho-physioepidemiological discussion of neonatal hypothermia applied to local risk factors within the developing country context with particular emphasis on prevention, recognition and management.Method: All available published literature on neonatal hypothermia relevant to resource poor settings were reviewed. Studies from the developing country settings were primarily reviewed for epidemiology, domiciliary risk factors as well as potential interventions for thermal care.Result and Discussion: Functional integrity and efficiency of biological systems is critically dependent on an optimal and very narrow range of core body temperature. Risk factors for neonatal hypothermia differ markedly within low resource settings. A combination of physiological, behavioral and environmental factors universally put all newborns, irrespective of birth weight, at risk of hypothermia. The knowledge deficit along the continuum from health providers to primary care givers has sustained the silent epidemic of hypothermia. The challenges of recognition, understanding of local risk factors and communication have meant a lack of informed thermal care for newborns. Simple, feasible interventions exist, but need to be applied, based on local risk factors that disrupt the warm chain. Further research is needed to document local risk factors, develop better techniques for recognition, evaluation of thermal care within essential newborn care and communication strategies for program effectiveness. Keywords: hypothermia; skin-to-skin care; warm chain; community; newborn; neonatal health Introduction 'If a definition of life were required, it must be most clearly on that capacity, by which the animal preserves its proper heat under the various degrees of temperature of the medium in which it livesy a few degrees of increase or diminution of the heat of the system, produces disease and death' said James Currie some two centuries ago, recognizing the central importance of temperature regulation in health. 1 Although folklore associated with increased temperature or fever has been recorded throughout history across virtually every culture and civilization, a recognition of hypothermia and its clinical significance, particularly for newborn health is a relatively recent advance. 1,2 Moreover, progress toward thermal care of newborns in developed countries has far outstripped knowledge and practice in developing country settings, where 99% of global neonatal deaths occur. 3,4 Hypothermia during the newborn period is widely regarded as a...

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“…An example is a study of interventions to reduce neonatal mortality. 18 The intervention, which consisted primarily of education on newborn care, was randomly assigned to whole villages at a time, but in principle individuals could opt out of receiving it. Sim and Dawson argue that omission of informed consent in such cases is justifiable if consent would be Bincompatible with the methodological integrity of the study,^a determination that they suggest should be made by IRBs on a case-by-case basis.…”

Section: Designs Based On Infeasibility Of Informed Consentmentioning

confidence: 99%

“…Although the Zelen design is often associated with oncology trials, examples exist in other therapeutic areas: for There would be no other means of conducting this research, and the research is considered important for public health Individual-cluster cluster randomization 17 Routinely used A randomized intervention occurs at the individual level, but effect is studied at the community, or cluster level Site-randomized trial of behavior change intervention reducing neonatal mortality 18 While possible, individual consent would be Bdeemed incompatible with the methodological integrity of the studyĈ luster-cluster cluster randomization 17 Routinely used A randomized intervention, such as an environmental management trial, occurs at the community level and is also studied at that level Site-randomized trial of an integrated community-based environmental management strategy to prevent dengue fever 19 Individual consent is clearly infeasible: "On both logical and logistical grounds, individual informed consent is difficult if not impossible in a cluster-cluster randomized trialT …”

Section: Esigns That Omit Informed Consent For Control Groupsmentioning

confidence: 99%

Proposals to Conduct Randomized Controlled Trials Without Informed Consent: a Narrative Review

2016

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BACKGROUND: Individual informed consent from all participants is required for most randomized clinical trials (RCTs). However, some exceptions-for example, emergency research-are widely accepted. METHODS: The literature on various approaches to randomization without consent (RWOC) has never been systematically reviewed. Our goal was to provide a survey and narrative synthesis of published proposals for RWOC. We focused on proposals to randomize at least some participants in a study without first obtaining consent to randomization. This definition included studies that omitted informed consent entirely, omitted informed consent for selected patients (e.g., the control group), obtained informed consent to research but not to randomization, or only obtained informed consent to randomization after random assignment had already occurred. It omitted oral and staged consent processes that still obtain consent to randomization from all participants before randomization occurs. RESULTS: We identified ten different proposals for RWOC: two variants of cluster randomization, two variants of the Zelen design, consent to postponed information, two-stage randomized consent, cohort multiple RCT, emergency research, prompted optional randomization trials, and low-risk pragmatic RCTs without consent. CONCLUSION: Of all designs discussed here, only cluster randomized designs and emergency research are routinely used, with the justification that informed consent is infeasible in those settings. Other designs have raised concerns that they do not appropriately respect patient autonomy. Recent proposals have emphasized the importance for RWOC of demonstrating such respect through systematic patient engagement, transparency, and accountability, potentially in the context of learning health care systems. INTRODUCTIONRandomized controlled trials (RCTs) are the gold standard for clinical research. 1 Informed consent, including disclosure of randomization, is an ethical requirement for most RCTs. 2 This principle, intended to protect participants' autonomy and dignity, is firmly embedded in guidelines and regulations. [3][4][5][6] But, critics have argued that modern consent processes often fail to convey information well, can confuse or distress participants, and may even hinder legitimate research endeavors to the point where patients are paradoxically harmed by the lack of research on the safety and effectiveness of commonly used therapies. 7,8 These arguments have led to calls to relax or eliminate informed consent requirements in certain circumstances. An example is the exception for emergency medicine studies in which it is deemed impossible to obtain informed consent and still test an emergent intervention. 9 More broadly, US Federal regulations allow a waiver of informed consent requirements for clinical research given that four requirements are met: (1) Bthe research involves no more than minimal risk to the subjects,^(2) Bthe waiver or alteration will not adversely affect the rights and welfare of the subjects,^(3) Bthe researc...

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Effect of community-based behaviour change management on neonatal mortality in Shivgarh, Uttar Pradesh, India: a cluster-randomised controlled trial

Cited by 432 publications

References 37 publications

Rethinking How to Promote Maternity Care-Seeking: Factors Associated With Institutional Delivery in Guinea

Rethinking How to Promote Maternity Care-Seeking: Factors Associated With Institutional Delivery in Guinea

Neonatal hypothermia in low resource settings: a review

Proposals to Conduct Randomized Controlled Trials Without Informed Consent: a Narrative Review

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