Implementation research to increase treatment coverage of possible serious bacterial infections in young infants when a referral is not feasible: lessons learnt.

BACKGROUND: The objective was to achieve high coverage of possible serious bacterial infections (PSBI) treatment using the World Health Organization (WHO) guideline for managing it on an outpatient basis when referral to a hospital is not feasible. METHODS: We implemented this guideline in the programme settings at 10 Basic Health Units (BHU) in two rural districts of Sindh in Pakistan using implementation research. A Technical Support Unit supported the programme to operationalize guidelines, built capacity of health workers through training, monitored their clinical skills, mentored them and assured quality. The community-based health workers visited households to identify sick infants and referred them to the nearest BHU for further management. The research team collected data. RESULTS: Of 17 600 identified livebirths, 1860 young infants with any sign of PSBI sought care at BHUs and 1113 (59.8%) were brought by families. We achieved treatment coverage of 95%, assuming an estimated 10% incidence of PSBI in the first 2 months of life and that 10% of young infants came from outside the study catchment area. All 923 infants (49%; 923/1860) 7-59 days old with only fast breathing (pneumonia) treated with outpatient oral amoxicillin were cured. Hospital referral was refused by 83.4% (781/937) families who accepted outpatient treatment; 92.2% (720/781) were cured and 0.8% (6/781) died. Twelve (7.6%; 12/156) died among those treated in a hospital. CONCLUSION: It is feasible to achieve high coverage by implementing WHO PSBI management guidelines in a programmatic setting when a referral is not feasible.

A multi-country implementation research initiative to jump-start scale-up of outpatient management of possible serious bacterial infections (PSBI) when a referral is not feasible: Summary findings and implications for programs.

INTRODUCTION: Research on simplified antibiotic regimens for outpatient treatment of 'Possible Serious Bacterial Infection' (PSBI) and the subsequent World Health Organization (WHO) guidelines provide an opportunity to increase treatment coverage. This multi-country implementation research initiative aimed to learn how to implement the WHO guideline in diverse contexts. These experiences have been individually published; this overview paper provides a summary of results and lessons learned across sites. METHODS SUMMARY: A common mixed qualitative and quantitative methods protocol for implementation research was used in eleven sites in the Democratic Republic of Congo (Equateur province), Ethiopia (Tigray and Oromia regions), India (Haryana, Himachal Pradesh, Maharashtra, and Uttar Pradesh states), Malawi (Central Region), Nigeria (Kaduna and Oyo states), and Pakistan (Sindh province). Key steps in implementation research were: i) policy dialogue with the national government and key stakeholders, ii) the establishment of a 'Technical Support Unit' with the research team and district level managers, and iii) development of an implementation strategy and its refinement using an iterative process of implementation, programme learning and evaluation. RESULTS SUMMARY: All sites successfully developed and evaluated an implementation strategy to increase coverage of PSBI treatment. During the study period, a total of 6677 young infants from the study catchment area were identified and treated at health facilities in the study area as inpatients or outpatients among 88179 live births identified. The estimated coverage of PSBI treatment was 75.7% (95% CI 74.8% to 78.6%), assuming a 10% incidence of PSBI among all live births. The treatment coverage was variable, ranging from 53.3% in Lucknow, India to 97.3% in Ibadan, Nigeria. The coverage of inpatient treatment ranged from 1.9% in Zaria, Nigeria, to 33.9% in Tigray, Ethiopia. The outpatient treatment coverage ranged from 30.6% in Pune, India, to 93.6% in Zaria, Nigeria. Overall, the case fatality rate (CFR) was 14.6% (95% CI 11.5% to 18.2%) for 0-59-day old infants with critical illness, 1.9% (95% CI 1.5% to 2.4%) for 0-59-day old infants with clinical severe infection and 0.1% for fast breathing in 7-59 days old. Among infants treated as outpatients, CFR was 13.7% (95% CI 8.7% to 20.2%) for 0-59-day old infants with critical illness, 0.9% (95% CI 0.6% to 1.2%) for 0-59-day old infants with clinical severe infection, and 0.1% for infants 7-59 days old with fast breathing. CONCLUSION: Important lessons on how to conduct each step of implementation research, and the challenges and facilitators for implementation of PSBI management guideline in routine health systems are summarised and discussed. These lessons will be used to introduce and scale-up implementation in relevant Low- and middle-income countries.

Unpacking cesarean in rural Bangladesh: Who, what, when, and where.

BACKGROUND: Bangladesh has experienced an alarming increase in birth through cesarean over the last decade. In this article, we examine rural Bangladeshi women's reporting of why they underwent cesarean, who proposed the cesarean, and when in the process, the decision for a surgical birth was made. METHODS: We conducted a cross-sectional household survey of 2299 women in Kushtia district. Of these, 1233 who gave birth through cesarean completed a supplemental questionnaire. Descriptive statistics were used to report cesarean rates, which were disaggregated by sociodemographic characteristics and by antenatal care contacts with health services. We analyzed women's reported reasons for having a cesarean, when the decision was taken, and who proposed the intervention. FINDINGS: Over half (54%) of women gave birth through cesarean. The proportion of cesareans was significantly higher among women with higher educational attainment, higher socioeconomic status, and increased antenatal care during pregnancy, particularly if this care was sought in private facilities (P < .05). Women reported that health service providers primarily proposed the cesarean (73%), followed by family members (21%) and finally, the birthing person themselves (6%). With respect to the reasons for cesarean, 34% of women reported nonmedical reasons (convenience and avoidance of labor pain), and 44% mentioned only medical reasons. Over half of the women reported that the decision to undergo a cesarean was made on the day of birth. CONCLUSIONS: Women in rural Bangladesh often report avoidable reasons for cesarean. Better regulation of cesarean services in both public and private health services, as well as improved counseling of women with respect to cesarean indications and their consequences, is recommended.

Monitoring the implementation and scale-up of a life-saving intervention for preterm and small babies: Facility-based Kangaroo Mother Care.

BACKGROUND: Kangaroo mother care (KMC) is an evidence-based intervention with large protective effects on neonatal mortality and morbidity, especially among small babies. Despite the available evidence, KMC adoption, implementation and scale-up has lagged. The purpose of this paper is to inform current and future KMC implementation by identifying achievements and challenges in countries that are in the process of scaling up KMC. METHODS: We collected and analyzed information to track the status of facility-based KMC in countries identified by the KMC Acceleration Partnership. We assessed the status of the scale-up in six priority countries (Ethiopia, Malawi, Nigeria and Rwanda in Africa, and Bangladesh and India in Asia) for three periods: 2014 and prior, 2015-2017 and 2017-2019 across six strategic areas: national policy, country implementation, research, knowledge management, monitoring and evaluation and advocacy. We collected information through in-depth interviews with key participants, quantitative data extraction from the Demographic Health Survey and secondary data extraction from policies, briefs, program reports and other documents. RESULTS: Progress in terms of national policy and advocacy appeared to occur quite quickly and evenly across the six priority countries, despite being at different stages during the first assessment. In the areas of country implementation support and research, progress occurred more slowly and results were more variable across countries. It was noted that the number of health facilities offering KMC services increased in all six priority countries, but coverage of KMC was difficult to estimate, demonstrating the ongoing challenges in the area of monitoring and evaluation despite progress made in integrating KMC indicators into national health information systems in five countries. Among the six priority countries - Malawi and Bangladesh had fully achieved at least four the first time six conditions were introduced. CONCLUSIONS: We documented notable achievements in the dimensions of policy and country implementation across the six countries, which were likely driven by government engagement to prioritize newborn care services and the promotion of KMC as a core intervention for small babies. We noted challenges in critical areas such as ambulatory KMC, follow-up, and monitoring and evaluation. Addressing these gaps while securing funding to allocate human resources adequately, promoting acceptance of KMC for demand creation and facilitating the use of data for decision making will be vital to ensure effective coverage at scale.

Changes in attitudes and behaviors supportive of maternal and newborn health in Ethiopia: an evaluative case study.

BACKGROUND: Ethiopia's high neonatal mortality rate led to the government's 2013 introduction of Community-Based Newborn Care (CBNC) to bring critical prevention and treatment interventions closer to communities in need. However, complex behaviors that are deeply embedded in social and cultural norms continue to prevent women and newborns from getting the care they need. A demand creation strategy was designed to create an enabling environment to support appropriate maternal, newborn, and child health (MNCH) behaviors and CBNC. We explored the extent to which attitudes and behaviors during the prenatal and perinatal periods varied by the implementation strength of the Demand Creation Strategy for MNCH-CBNC. METHODS: Using an embedded, multiple case study design, we purposively selected four kebeles (villages) from two districts with different levels of implementation strength of demand creation activities. We collected information from a total of 150 key stakeholders across kebeles using multiple qualitative methods including in-depth interviews, focus group discussions, and illness narratives; sessions were transcribed into English and coded using NVivo 10.0. We developed case reports for each kebele and a final cross-case report to compare results from high and low implementation strength kebeles. RESULTS: We found that five MNCH attitudes and behaviors varied by implementation strength. In high implementation strength kebeles women felt more comfortable disclosing their pregnancy early, women sought antenatal care (ANC) in the first trimester, families did not have fatalistic ideas about newborn survival, mothers sought care for sick newborns in a timely manner, and newborns received care at the health facility in less than an hour. We also found changes across all kebeles that did not vary by implementation strength, including male engagement during pregnancy and a preference for giving birth at a health facility. CONCLUSIONS: Findings suggest that a demand creation approach-combining participatory approaches with community empowering strategies-can promote shifts in behaviors and attitudes to support the health of mothers and newborns, including use of MNCH services. Future studies need to consider the most efficient level of intervention intensity to make the greatest impact on MNCH attitudes and behaviors.

The availability of global guidance for the promotion of women's, newborns', children's and adolescents' health and nutrition in conflicts.

BACKGROUND: Significant global gains in sexual, reproductive, maternal, newborn, child and adolescent health and nutrition (SRMNCAH&N) will be difficult unless conflict settings are adequately addressed. We aimed to determine the amount, scope and quality of publically available guidance documents, to characterise the process by which agencies develop their guidance and to identify gaps in guidance on SRMNCAH&N promotion in conflicts. METHODS: We identified guidance documents published between 2008 and 2018 through English-language Internet sites of humanitarian response organisations, reviewed them for their scope and assessed their quality with the AGREE II (Appraisal of Guidelines for REsearch and Evaluation II) tool. Additionally, we interviewed 22 key informants on guidance development, dissemination processes, perceived guidance gaps and applicability. FINDINGS: We identified 105 conflict-relevant guidance documents from 75 organisations. Of these, nine were specific to conflicts, others were applicable also to other humanitarian settings. Fifteen documents were technical normative guidelines, others were operational guides (67), descriptive documents (21) or advice on legal, human rights or ethics questions (2). Nutrition was the most addressed health topic, followed by communicable diseases and violence. The documents rated high quality in their 'scope and purpose' and 'clarity of presentation' and low for 'rigour of development' and 'editorial independence'. Key informants reported end user need as the primary driver for guideline development and WHO technical guidelines as their main evidence base. Insufficient local contextualisation, lack of inter-agency coordination and lack of systematic implementation were considered problems in guideline development. Several guidance gaps were noted, including abortion care, newborn care, early child development, mental health, adolescent health beyond sexual and reproductive health and non-communicable diseases. INTERPRETATION: Organisations are motivated and actively producing guidance for SRMNCAH&N promotion in humanitarian settings, but few documents address conflicts specifically and there are important guidance gaps. Improved inter-organisation collaboration for guidance on SRMNCAH&N promotion in conflicts and other humanitarian settings is needed.

Early implementation of guidelines for managing young infants with possible serious bacterial infection in Bangladesh.

Neonatal infections remain a leading cause of newborn deaths globally. In 2015, WHO issued guidelines for managing possible serious bacterial infection (PSBI) in young infants (0-59 days) with simpler antibiotic regimens if hospital referral is not feasible. Bangladesh was one of the first countries to adapt WHO guidance into national guidelines for implementation in primary healthcare facilities. Early implementation was led by the Ministry of Health and Family Welfare (MOHFW) in 10 subdistricts of Bangladesh with support from USAID's MaMoni Health System Strengthening project. This mixed methods implementation research case study explores programme feasibility and acceptability through analysis of service delivery data from 4590 sick young infants over a 15-month period, qualitative interviews with providers and MOHFW managers and documentation by project staff. Multistakeholder collaboration was key to ensuring facility readiness and feasibility of programme delivery. For the 514 (11%) infants classified as PSBI, provider adherence to prereferral treatment and follow-up varied across infection subcategories. Many clinical severe infection cases for whom referral was not feasible received the recommended two doses of injectable gentamicin and follow-up, suggesting delivery of simplified antibiotic treatment is feasible. However, prereferral antibiotic treatment was low for infants whose families accepted hospital referral, which highlights the need for additional focus on managing these cases in training and supervision. Systems for tracking sick infants that accept hospital referral are needed, and follow-up of all PSBI cases requires strengthening to ensure sick infants receive the recommended treatment, to monitor outcomes and assess the effectiveness of the programme. Only 11.2% (95% CI 10.3 to 12.1) of the expected PSBI cases sought care from the selected service delivery points in the programme period. However, increasing trends in utilisation suggest improved awareness and acceptability of services among families of young infants as the programme matured. Future programme activities should include interviews with caregivers to explore the complexities around referral feasibility and acceptability of simplified antibiotic treatment.

The Nonsurgical Management of Orbital Dystopia Using Refractive Lenses and Prosthetic Shells.

Surgical rehabilitation of orbital dystopia can be challenging. The authors demonstrate the effective use of spectacle lenses to visually correct misalignments of the globe and the orbit. Presented is a retrospective review of 4 patients undergoing aesthetic rehabilitation through use of spectacle lenses and in a number patients a cosmetic shell.Two patients with neurofibromatosis presented with inferior dystopia of the globe and orbit. A base-down prismatic lens applied to the spectacles in conjunction with a prosthetic shell successfully visually corrected the facial asymmetry and improved patients' aesthetic appearance. One patient with a history of traumatic retinal detachment, who did not want any surgical intervention, a "plus" (hypermetropic) lens was used to magnify the perceived image of an enophthalmic and phthisical globe, to enhance appearance and improve symmetry. In the fourth patient, with Goldenhar syndrome, the appearance of a hypotropia and concurrent esotropia was successfully treated with a Fresnel prism and a prosthetic shell.This case series illustrates the successful role of various refractive lenses often in conjunction with prosthetic shells in patients with reduced vision and orbital dystopia to improve facial symmetry. This conservative treatment is especially useful when surgery is not a desired or not considered a suitable option for the patient.

Bolivia programme evaluation of a package to reach an underserved population: Community-based maternal and newborn care economic analysis.

To address inequitable access to health services of indigenous communities in the Bolivian highlands, the Bolivian Ministry of Health, with the support of Save the Children-Saving Newborn Lives, conducted operational research to identify, implement and test a package of maternal and newborn interventions using locally recruited, volunteer Community Health Workers (vCHW) between 2008 and 2010. The additional annual economic and financial costs of the intervention were estimated from the perspective of the Bolivian Ministry of Health in two municipalities. The cost of intervention-stimulated increases in facility attendance was estimated with national surveillance data using a pre-post comparison, adjusted for secular trends in facility attendance. Three scale-up scenarios were modelled by varying the levels of coverage and the number (per mother and child pair) and frequency of home visits. Average cost per mother and average cost per home visit are presented in constant 2015 US$. Eighteen per cent of expectant mothers in the catchment area were visited at least once. The annualized additional financial cost of the community-based intervention across both municipalities was $43 449 of which 3% ($1324) was intervention design, 20% ($8474) set-up and 77% ($33 651) implementation. Drivers of additional costs were additional paid staff (68%), 81% of which was for management and support by local implementing partner and 19% of which was for vCHW supervision. The annual financial cost per vCHW was $595. Modelled scale-up scenarios highlight potential efficiency gains. Recognizing local imperatives to reduce inequalities by targeting underserved populations, the observed low coverage by vCHWs resulted in a high cost per mother and child pair ($296). This evaluation raises important questions about this model's ability to achieve its ultimate goals of reducing neonatal mortality and inequalities through behaviour change and increased care seeking and has served to inform innovative alternative models, better equipped to tackle stagnant inequitable access to care.

Effect of provision of home-based curative health services by public sector health-care providers on neonatal survival: a community-based cluster-randomised trial in rural Pakistan.

BACKGROUND: Although the effectiveness of community mobilisation and promotive care delivered by community health workers in reducing perinatal and neonatal mortality is well established, evidence in support of home-based neonatal resuscitation and infection management is mixed. We assessed the effectiveness of adding training in neonatal bag and mask resuscitation and oral antibiotic therapy for suspected neonatal infections to a basic preventive and promotive interventions package delivered by public sector community-based lady health workers (LHWs) in rural Pakistan. METHODS: We did a cluster-randomised controlled trial in two subdistricts of Naushahro Feroze in rural Sindh, Pakistan, between April 15, 2009, and Dec 10, 2012. LHWs, trained in basic newborn resuscitation and in recognition and treatment (with oral amoxicillin) of suspected neonatal respiratory infections, were linked with traditional birth attendants and encouraged to attend home births. Control clusters received routine care through the existing national programme. The primary outcome was all-cause neonatal mortality. Independent data collection teams recorded data for all pregnancies and their outcomes, morbidity, mortality, and household practices related to maternal and newborn care. FINDINGS: Of the 27 randomised clusters with functional LHW programmes, 13 were allocated to the intervention group (n=242 749) and 14 to the control group (n=256 985). In the intervention group, LHWs did 80% of the planned community mobilisation sessions, but were able to attend only 1184 (14%) of 8425 deliveries and 4318 (25%) of 17 288 neonatal visits within 72 h of birth (p<0·0001 for both variables compared with the control group). The neonatal mortality rate was 42 deaths per 1000 livebirths in intervention clusters compared with 55 per 1000 in the control group (risk ratio 0·80, 95% CI 0·68-0·93; p=0·005). INTERPRETATION: The reduction in neonatal mortality in intervention clusters occurred against a background of improvements in domiciliary practices for maternal and newborn care. However, the poor reach of LHWs in accessing newborn infants at birth and in the early postnatal period underscores the limitations of tasking community health workers in public sector programmes working in similar circumstances with such complex interventions. Such community-based interventions in health systems should be accompanied by concerted efforts to improve quality of care in facilities and referral systems. FUNDING: Saving Newborn Lives, Save the Children USA.

Effect on Neonatal Mortality of Newborn Infection Management at Health Posts When Referral Is Not Possible: A Cluster-Randomized Trial in Rural Ethiopia.

BACKGROUND: The World Health Organization recently provided guidelines for outpatient treatment of possible severe bacterial infections (PSBI) in young infants, when referral to hospital is not feasible. This study evaluated newborn infection treatment at the most peripheral level of the health system in rural Ethiopia. METHODS: We performed a cluster-randomized trial in 22 geographical clusters (11 allocated to intervention, 11 to control). In both arms, volunteers and government-employed Health Extension Workers (HEWs) conducted home visits to pregnant and newly delivered mothers; assessed newborns; and counseled caregivers on prevention of newborn illness, danger signs, and care seeking. Volunteers referred sick newborns to health posts for further assessment; HEWs referred newborns with PSBI signs to health centers. In the intervention arm only, between July 2011 and June 2013, HEWs treated newborns with PSBI with intramuscular gentamicin and oral amoxicillin for 7 days at health posts when referral to health centers was not possible or acceptable to caregivers. Intervention communities were informed of treatment availability at health posts to encourage care seeking. Masking was not feasible. The primary outcome was all-cause mortality of newborns 2-27 days after birth, measured by household survey data. Baseline data were collected between June 2008 and May 2009; endline data, between February 2013 and June 2013. We sought to detect a 33% mortality reduction. Analysis was by intention to treat. (ClinicalTrials.gov registry: NCT00743691). RESULTS: Of 1,011 sick newborns presenting at intervention health posts, 576 (57%) were identified by HEWs as having at least 1 PSBI sign; 90% refused referral and were treated at the health post, with at least 79% completing the antibiotic regimen. Estimated treatment coverage at health posts was in the region of 50%. Post-day 1 neonatal mortality declined more in the intervention arm (17.9 deaths per 1,000 live births at baseline vs. 9.4 per 1,000 at endline) than the comparison arm (14.4 per 1,000 vs. 11.2 per 1,000, respectively). After adjusting for baseline mortality and region, the estimated post-day 1 mortality risk ratio was 0.83, but the result was not statistically significant (95% confidence interval, 0.55 to 1.24; P=.33). INTERPRETATION: When referral to higher levels of care is not possible, HEWs can deliver outpatient antibiotic treatment of newborns with PSBI, but estimated treatment coverage in a rural Ethiopian setting was only around 50%. While our data suggest a mortality reduction consistent with that which might be expected at this level of coverage, they do not provide conclusive results.

Treatment of neonatal infections: a multi-country analysis of health system bottlenecks and potential solutions.

BACKGROUND: Around one-third of the world's 2.8 million neonatal deaths are caused by infections. Most of these deaths are preventable, but occur due to delays in care-seeking, and access to effective antibiotic treatment with supportive care. Understanding variation in health system bottlenecks to scale-up of case management of neonatal infections and identifying solutions is essential to reduce mortality, and also morbidity. METHODS: A standardised bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the development of the Every Newborn Action Plan. Country workshops involved technical experts to complete a survey tool, to grade health system "bottlenecks" hindering scale up of maternal-newborn intervention packages. Quantitative and qualitative methods were used to analyse the data, combined with literature review, to present priority bottlenecks and synthesise actions to improve case management of newborn infections. RESULTS: For neonatal infections, the health system building blocks most frequently graded as major or significant bottlenecks, irrespective of mortality context and geographical region, were health workforce (11 out of 12 countries), and community ownership and partnership (11 out of 12 countries). Lack of data to inform decision making, and limited funding to increase access to quality neonatal care were also major challenges. CONCLUSIONS: Rapid recognition of possible serious bacterial infection and access to care is essential. Inpatient hospital care remains the first line of treatment for neonatal infections. In situations where referral is not possible, the use of simplified antibiotic regimens for outpatient management for non-critically ill young infants has recently been reported in large clinical trials; WHO is developing a guideline to treat this group of young infants. Improving quality of care through more investment in the health workforce at all levels of care is critical, in addition to ensuring development and dissemination of national guidelines. Improved information systems are needed to track coverage and adequately manage drug supply logistics for improved health outcomes. It is important to increase community ownership and partnership, for example through involvement of community groups.

Count every newborn; a measurement improvement roadmap for coverage data.

BACKGROUND: The Every Newborn Action Plan (ENAP), launched in 2014, aims to end preventable newborn deaths and stillbirths, with national targets of ≤12 neonatal deaths per 1000 live births and ≤12 stillbirths per 1000 total births by 2030. This requires ambitious improvement of the data on care at birth and of small and sick newborns, particularly to track coverage, quality and equity. METHODS: In a multistage process, a matrix of 70 indicators were assessed by the Every Newborn steering group. Indicators were graded based on their availability and importance to ENAP, resulting in 10 core and 10 additional indicators. A consultation process was undertaken to assess the status of each ENAP core indicator definition, data availability and measurement feasibility. Coverage indicators for the specific ENAP treatment interventions were assigned task teams and given priority as they were identified as requiring the most technical work. Consultations were held throughout. RESULTS: ENAP published 10 core indicators plus 10 additional indicators. Three core impact indicators (neonatal mortality rate, maternal mortality ratio, stillbirth rate) are well defined, with future efforts needed to focus on improving data quantity and quality. Three core indicators on coverage of care for all mothers and newborns (intrapartum/skilled birth attendance, early postnatal care, essential newborn care) have defined contact points, but gaps exist in measuring content and quality of the interventions. Four core (antenatal corticosteroids, neonatal resuscitation, treatment of serious neonatal infections, kangaroo mother care) and one additional coverage indicator for newborns at risk or with complications (chlorhexidine cord cleansing) lack indicator definitions or data, especially for denominators (population in need). To address these gaps, feasible coverage indicator definitions are presented for validity testing. Measurable process indicators to help monitor health service readiness are also presented. A major measurement gap exists to monitor care of small and sick babies, yet signal functions could be tracked similarly to emergency obstetric care. CONCLUSIONS: The ENAP Measurement Improvement Roadmap (2015-2020) outlines tools to be developed (e.g., improved birth and death registration, audit, and minimum perinatal dataset) and actions to test, validate and institutionalise proposed coverage indicators. The roadmap presents a unique opportunity to strengthen routine health information systems, crosslinking these data with civil registration and vital statistics and population-based surveys. Real measurement change requires intentional transfer of leadership to countries with the greatest disease burden and will be achieved by working with centres of excellence and existing networks.

Economic evaluation of neonatal care packages in a cluster-randomized controlled trial in Sylhet, Bangladesh.

OBJECTIVE: To evaluate and compare the cost-effectiveness of two strategies for neonatal care in Sylhet division, Bangladesh. METHODS: In a cluster-randomized controlled trial, two strategies for neonatal care--known as home care and community care--were compared with existing services. For each study arm, economic costs were estimated from a societal perspective, inclusive of programme costs, provider costs and household out-of-pocket payments on care-seeking. Neonatal mortality in each study arm was determined through household surveys. The incremental cost-effectiveness of each strategy--compared with that of the pre-existing levels of maternal and neonatal care--was then estimated. The levels of uncertainty in our estimates were quantified through probabilistic sensitivity analysis. FINDINGS: The incremental programme costs of implementing the home-care package were 2939 (95% confidence interval, CI: 1833-7616) United States dollars (US$) per neonatal death averted and US$ 103.49 (95% CI: 64.72-265.93) per disability-adjusted life year (DALY) averted. The corresponding total societal costs were US$ 2971 (95% CI: 1844-7628) and US$ 104.62 (95% CI: 65.15-266.60), respectively. The home-care package was cost-effective--with 95% certainty--if healthy life years were valued above US$ 214 per DALY averted. In contrast, implementation of the community-care strategy led to no reduction in neonatal mortality and did not appear to be cost-effective. CONCLUSION: The home-care package represents a highly cost-effective intervention strategy that should be considered for replication and scale-up in Bangladesh and similar settings elsewhere.

An innovative multipartner research program to address detection, assessment and treatment of neonatal infections in low-resource settings.

BACKGROUND: In pursuit of innovative approaches for the management of severe infections in young infants, which is a major cause of mortality, a multipartner research program was conceptualized to provide right care in the right place. The primary objective was to generate evidence and identify a simple, safe and effective treatment regimen for young infants with severe infections that can be provided closer to home by trained health workers where referral is not possible. RESEARCH: Published and nonpublished data on community-based approaches for the management of neonatal sepsis were critically reviewed by an independent expert panel convened in 2007 by the World Health Organization in collaboration with the United States Agency for International Development and Save the Children/Saving Newborn Lives. These stakeholders agreed to 1) undertake research to improve the specificity of a diagnostic algorithm and revise World Health Organization/United Nations International Children's Emergency Fund Integrated Management of Childhood Illness guidelines to identify sick young infants for referral, 2) develop research studies with common research designs (1 site in each Bangladesh and Pakistan and a multicentre site in Democratic Republic of Congo, Kenya and Nigeria) and oversight mechanisms to evaluate antibiotic regimens (when referral is not accepted by the family) that are safe and efficacious, appropriate to the severity of infection, and deployable on a large scale and 3) utilize existing program delivery structures incorporating community health workers, skilled health workers to deliver simple antibiotic treatment when referral is not possible. CONCLUSIONS: This research program facilitated innovative research in different geographical, cultural and administrative milieus to generate recommendations for policy.

Scientific rationale for study design of community-based simplified antibiotic therapy trials in newborns and young infants with clinically diagnosed severe infections or fast breathing in South Asia and sub-Saharan Africa.

BACKGROUND: Newborns and young infants suffer high rates of infections in South Asia and sub-Saharan Africa. Timely access to appropriate antibiotic therapy is essential for reducing mortality. In an effort to develop community case management guidelines for young infants, 0-59 days old, with clinically diagnosed severe infections, or with fast breathing, 4 trials of simplified antibiotic therapy delivered in primary care clinics (Pakistan, Democratic Republic of Congo, Kenya and Nigeria) or at home (Bangladesh and Nigeria) are being conducted. METHODS: This article describes the scientific rationale for these trials, which share major elements of trial design. All the trials are in settings of high neonatal mortality, where hospitalization is not feasible or frequently refused. All use procaine penicillin and gentamicin intramuscular injections for 7 days as reference therapy and compare this to various experimental arms utilizing comparatively simpler combination regimens with fewer injections and oral amoxicillin. CONCLUSION: The results of these trials will inform World Health Organization policy regarding community case management of young infants with clinical severe infections or with fast breathing.

A conference report on prenatal corticosteroid use in low- and middle-income countries.

OBJECTIVE: To evaluate the evidence for prenatal corticosteroid use in low- and middle-income countries and to make recommendations regarding implementation and further research. METHODS: Studies and meta-analyses on prenatal corticosteroids relevant to low- and middle-income countries were identified and reviewed at the Maternal and Child Health Integrated Project (MCHIP) Antenatal Corticosteroid Conference held in Washington on October 19, 2010. RESULTS: There is strong evidence regarding the effectiveness of prenatal corticosteroid use in hospitals in high- and middle-income countries, usually in settings with high-level newborn care. For births occurring in hospitals in low-income countries without high-level neonatal care or for births outside hospitals, no studies have been conducted to evaluate prenatal corticosteroid use. The efficacy and safety of prenatal corticosteroid use in these settings must be evaluated. CONCLUSIONS: The conference working group recommended expanding the use of prenatal corticosteroids in hospitals with high-level newborn care in low-income countries. For other low-income country settings, further research regarding efficacy and safety should precede the widespread introduction of prenatal corticosteroids.