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.

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.

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 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.

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.

Vayu bubble continuous positive airway pressure is a promising solution with favorable treatment outcomes for respiratory distress syndrome in newborns: a qualitative study in Bangladesh.

Background: According to Bangladesh Demographic and Health Survey (2022), neonatal mortality, comprising 67% of under-5 deaths in Bangladesh, is significantly attributed to prematurity and low birth weight (LBW), accounting for 32% of neonatal deaths. Respiratory distress syndrome (RDS) is a prevalent concern among preterm and LBW infants, leading to substantial mortality. The World Health Organization (WHO) recommends bubble continuous positive airway pressure (bCPAP) therapy, but the affordability and accessibility of conventional bCPAP devices for a large number of patients become major hurdles in Bangladesh due to high costs and resource intensiveness. The Vayu bCPAP, a simple and portable alternative, offers a constant flow of oxygen-enriched, filtered, humidified, and pressurized air. Our study, conducted in five health facilities, explores the useability, acceptability, and perceived treatment outcome of Vayu bCPAP in the local context of Bangladesh. Methods: A qualitative approach was employed in special care newborn units (SCANUs) of selected facilities from January to March 2023. Purposive sampling identified nine key informants, 40 in-depth interviews with service providers, and 10 focus group discussions. Data collection and analysis utilized a thematic framework approach led by trained anthropologists and medical officers. Results: Service providers acknowledged Vayu bCPAP as a lightweight, easily movable, and cost-effective device requiring minimal training. Despite challenges such as consumable shortages and maintenance issues, providers perceived the device as user-friendly, operable with oxygen cylinders, and beneficial during referral transportation. Treatment outcomes indicated effective RDS management, reduced hospital stays, and decreased referrals. Though challenges existed, healthcare providers and facility managers expressed enthusiasm for Vayu bCPAP due to its potential to simplify advanced neonatal care delivery. Conclusions: The Vayu bCPAP device demonstrated useability, acceptability, and favorable treatment outcomes in the care of neonates with RDS. However, sustained quality service necessitates continuous monitoring, mentoring and retention of knowledge and skills. Despite challenges, the enthusiasm among healthcare providers underscores the potential of Vayu bCPAP to save lives and simplify neonatal care delivery. Development of Standard Operating procedure on Vayu bCPAP is required for systematic implementation. Further research is needed to determine how the utilization of Vayu bCPAP devices enhances accessibility to efficient bCPAP therapy for neonates experiencing RDS.

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.

Improvement of perinatal and newborn care in rural Pakistan through community-based strategies: a cluster-randomised effectiveness trial.

BACKGROUND: Newborn deaths account for 57% of deaths in children younger than 5 years in Pakistan. Although a large programme of trained lady health workers (LHWs) exists, the effectiveness of this training on newborn outcomes has not been studied. We aimed to evaluate the effectiveness of a community-based intervention package, principally delivered through LHWs working with traditional birth attendants and community health committees, for reduction of perinatal and neonatal mortality in a rural district of Pakistan. METHODS: We undertook a cluster randomised trial between February, 2006, and March, 2008, in Hala and Matiari subdistricts, Pakistan. Catchment areas of primary care facilities and all affiliated LHWs were used to define clusters, which were allocated to intervention and control groups by restricted, stratified randomisation. The intervention package delivered by LHWs through group sessions consisted of promotion of antenatal care and maternal health education, use of clean delivery kits, facility births, immediate newborn care, identification of danger signs, and promotion of careseeking; control clusters received routine care. Independent data collectors undertook quarterly household surveillance to capture data for births, deaths, and household practices related to maternal and newborn care. Data collectors were masked to cluster allocation; those analysing data were not. The primary outcome was perinatal and all-cause neonatal mortality. Analysis was by intention to treat. This trial is registered, ISRCTN16247511. FINDINGS: 16 clusters were assigned to intervention (23,353 households, 12,391 total births) and control groups (23,768 households, 11,443 total births). LHWs in the intervention clusters were able to undertake 4428 (63%) of 7084 planned group sessions, but were only able to visit 2943 neonates (24%) of a total 12,028 livebirths in their catchment villages. Stillbirths were reduced in intervention clusters (39·1 stillbirths per 1000 total births) compared with control (48·7 per 1000; risk ratio [RR] 0·79, 95% CI 0·68-0·92; p=0·006). The neonatal mortality rate was 43·0 deaths per 1000 livebirths in intervention clusters compared with 49·1 per 1000 in control groups (RR 0·85, 0·76-0·96; p=0·02). INTERPRETATION: Our results support the scale-up of preventive and promotive maternal and newborn interventions through community health workers and emphasise the need for attention to issues of programme management and coverage for such initiatives to achieve maximum potential. FUNDING: WHO; Saving Newborn Lives Program of Save the Children USA, funded by the Bill & Melinda Gates Foundation.

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.

Clean birth and postnatal care practices to reduce neonatal deaths from sepsis and tetanus: a systematic review and Delphi estimation of mortality effect.

BACKGROUND: Annually over 520,000 newborns die from neonatal sepsis, and 60,000 more from tetanus. Estimates of the effect of clean birth and postnatal care practices are required for evidence-based program planning. OBJECTIVE: To review the evidence for clean birth and postnatal care practices and estimate the effect on neonatal mortality from sepsis and tetanus for the Lives Saved Tool (LiST). METHODS: We conducted a systematic review of multiple databases. Data were abstracted into standard tables and assessed by GRADE criteria. Where appropriate, meta-analyses were undertaken. For interventions with low quality evidence but a strong GRADE recommendation, a Delphi process was conducted. RESULTS: Low quality evidence supports a reduction in all-cause neonatal mortality (19% (95% c.i. 1-34%)), cord infection (30% (95% c.i. 20-39%)) and neonatal tetanus (49% (95% c.i. 35-62%)) with birth attendant handwashing. Very low quality evidence supports a reduction in neonatal tetanus mortality with a clean birth surface (93% (95% c.i. 77-100%)) and no relationship between a clean perineum and tetanus. Low quality evidence supports a reduction of neonatal tetanus with facility birth (68% (95% c.i. 47-88%). No relationship was found between birth place and cord infections or sepsis mortality. For postnatal clean practices, all-cause mortality is reduced with chlorhexidine cord applications in the first 24 hours of life (34% (95% c.i. 5-54%, moderate quality evidence) and antimicrobial cord applications (63% (95% c.i. 41-86%, low quality evidence). One study of postnatal maternal handwashing reported reductions in all-cause mortality (44% (95% c.i. 18-62%)) and cord infection ((24% (95% c.i. 5-40%)).Given the low quality of evidence, a Delphi expert opinion process was undertaken. Thirty experts reached consensus regarding reduction of neonatal sepsis deaths by clean birth practices at home (15% (IQR 10-20)) or in a facility (27% IQR 24-36)), and by clean postnatal care practices (40% (IQR 25-50)). The panel estimated that neonatal tetanus mortality was reduced by clean birth practices at home (30% (IQR(20-30)), or in a facility (38% (IQR 34-40)), and by clean postnatal care practices (40% (IQR 30-50)). CONCLUSION: According to expert opinion, clean birth and particularly postnatal care practices are effective in reducing neonatal mortality from sepsis and tetanus. Further research is required regarding optimal implementation strategies.

What are the effects of metopic synostosis on visual function?

Metopic synostosis is a premature fusion of the metopic cranial suture. Small case studies into the effects on vision have suggested that there is a raised incidence of astigmatic refractive error with increased risk of failure to develop normal vision if reconstructive surgery is delayed beyond 7 months of age. The aim of this study was to look at a much larger group of patients to give more statistical significance on the incidence of significant refractive error and strabismus in cases of metopic synostosis and compare this with that known for the general population of children at a similar age. A secondary objective was to look at the age at surgery and the visual outcome. A retrospective analysis of case notes was carried out for 64 children with a confirmed diagnosis of metopic synostosis attending the Oxford Craniofacial Unit. Twenty children (31%) were found to have a visual problem, with 18 needing glasses to correct a refractive error and 10 having strabismus. The nature of refractive error was generally hypermetropia, in some cases combined with low astigmatism (1.5 diopters [D] or less). Only 1 child was recorded as having more than 1.5 D of astigmatism. The age at surgery did not seem to influence visual outcome. The incidence of significant refractive error requiring correction and strabismus across the metopic group (31%) was higher than that found in the general population of children at a similar age (5%-11%). This reinforces the importance of orthoptic/ophthalmic surveillance in metopic synostosis.

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.

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.

The increase of metopic synostosis: a pan-European observation.

Metopic synostosis is thought to have an incidence of about 1 in 15,000 births. Traditionally, this makes it the third most frequent single-suture craniosynostosis, after scaphocephaly (1 in 4200-8500) and plagiocephaly (1 in 11,000). Our units have, independently from each other, noted a marked increase in the number of metopic synostosis over the recent years. This is a pan-European, retrospective epidemiological study on the number of cases with metopic synostosis born between January 1, 1997, and January 1, 2006. This number was compared to the prevalence of scaphocephaly, the most frequently seen craniosynostosis. In the 7 units, a total of 3240 craniosynostosis were seen from 1997 until 2006. Forty-one percent (n = 1344) of those were sagittal synostosis, and 23% (n = 756) were metopic synostosis. There was a significant increase of the absolute number as well as of the percentage of metopic synostosis over these years (regression analysis, P = 0.017, R2 = 0.578) as opposed to a nonsignificant increase in the percentage of sagittal synostosis (P > 0.05, R2 = 0.368). The most remarkable increase occurred around 2000-2001, with the average of metopics being 20.1% from 1997 to 2000 and 25.5% from 2001 to 2005 (independent t-test, P = 0.002). The sagittal synostosis showed a smaller and nonsignificant increase in the same years: from 39.9% in 1997-2000 leading up to 42.5% in 2001-2005 (independent t-test, P > 0.05). The number of metopic synostosis has significantly increased over the reviewed period in all of our units, both in absolute numbers as in comparison to the total number of craniosynostosis.

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.

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.