A research agenda to improve incidence and outcomes of assisted vaginal birth.

Access to emergency obstetric care, including assisted vaginal birth and caesarean birth, is crucial for improving maternal and childbirth outcomes. However, although the proportion of births by caesarean section has increased during the last few decades, the use of assisted vaginal birth has declined. This is particularly the case in low- and middle-income countries, despite an assisted vaginal birth often being less risky than caesarean birth. We therefore conducted a three-step process to identify a research agenda necessary to increase the use of, or reintroduce, assisted vaginal birth: after conducting an evidence synthesis, which informed a consultation with technical experts who proposed an initial research agenda, we sought and incorporated the views of women's representatives of this agenda. This process has allowed us to identify a comprehensive research agenda, with topics categorized as: (i) the need to understand women's perceptions of assisted vaginal birth, and provide appropriate and reliable information; (ii) the importance of training health-care providers in clinical skills but also in respectful care, effective communication, shared decision-making and informed consent; and (iii) the barriers to and facilitators of implementation and sustainability. From women's feedback, we learned of the urgent need to recognize labour, childbirth and postpartum experiences as inherently physiological and dignified human processes, in which interventions should only be implemented if necessary. The promotion and/or reintroduction of assisted vaginal birth in low-resource settings requires governments, policy-makers and hospital administrators to support skilled health-care providers who can, in turn, respectfully support women in labour and childbirth.

L'accès aux soins obstétriques d'urgence, y compris l'accouchement vaginal assisté et la césarienne, est essentiel pour améliorer les effets de la maternité et de l'accouchement. Toutefois, bien que la proportion de césariennes ait augmenté ces dernières décennies, le recours à l'accouchement vaginal assisté a diminué. C'est particulièrement le cas dans les pays à revenu faible ou intermédiaire, bien que l'accouchement vaginal assisté soit souvent moins risqué qu'une césarienne. Nous avons donc mené un processus en trois étapes afin d'imaginer un programme de recherche qui permettrait d'augmenter le recours à l'accouchement vaginal assisté ou de le réintroduire. Après avoir réalisé une synthèse des données probantes, qui a servi de base à une consultation avec des experts techniques qui ont proposé un programme de recherche initial, nous avons sollicité et incorporé les avis des représentantes des femmes pour ce programme. Ce processus nous a permis d'imaginer un programme de recherche complet, avec des sujets classés comme suit: (i) la nécessité de comprendre la perception qu'ont les femmes de l'accouchement vaginal assisté et de fournir des informations appropriées et fiables; (ii) l'importance de la formation des prestataires de soins de santé en matière de compétences cliniques, mais aussi de respect dans les soins de santé, de communication efficace, de prise de décision partagée et de consentement éclairé; ou (iii) les obstacles à la mise en œuvre et à la durabilité et les facteurs qui les facilitent. Les réactions de femmes nous ont appris qu'il était urgent de reconnaître que l'accouchement, la naissance et le post-partum sont des processus humains intrinsèquement physiologiques et dignes au cours desquels les interventions ne devraient être mises en œuvre qu'en cas de nécessité. La promotion et/ou la réintroduction de l'accouchement vaginal assisté dans les régions à faibles ressources nécessitent que les pouvoirs publics, les décideurs politiques et les administrations d'hôpitaux soutiennent les prestataires de soins de santé qualifiés, qui pourront à leur tour soutenir respectueusement les femmes pendant l'accouchement.

El acceso a la atención obstétrica de emergencia, incluido el parto vaginal asistido y el parto por cesárea, es crucial para mejorar los resultados de la maternidad y el parto. No obstante, aunque el porcentaje de partos por cesárea ha aumentado en las últimas décadas, el uso del parto vaginal asistido ha disminuido. Esto ocurre especialmente en los países de ingresos bajos y medios, a pesar de que un parto vaginal asistido suele ser menos arriesgado que un parto por cesárea. Por lo tanto, llevamos a cabo un proceso de tres pasos para identificar un programa de investigación necesario para aumentar el uso del parto vaginal asistido o volver a incorporarlo: tras realizar una síntesis de la evidencia, que sirvió de base para una consulta con expertos técnicos que propusieron un programa de investigación inicial, buscamos e integramos las opiniones de las representantes de las mujeres sobre este programa. Este proceso nos ha permitido identificar un programa de investigación exhaustivo, con temas categorizados como: (i) la necesidad de comprender las percepciones de las mujeres sobre el parto vaginal asistido, y proporcionar información adecuada y fiable; (ii) la importancia de formar a los profesionales sanitarios en habilidades clínicas, pero también en atención respetuosa, comunicación efectiva, toma de decisiones compartida y consentimiento informado; o (iii) las barreras y los facilitadores de la implementación y la sostenibilidad. A partir de las opiniones de las mujeres, nos enteramos de la urgente necesidad de reconocer las experiencias del parto, el alumbramiento y el posparto como procesos humanos inherentemente fisiológicos y dignos, en los que las intervenciones solo deben aplicarse si son necesarias. La promoción o la reincoporación del parto vaginal asistido en regiones de escasos recursos exige que los gobiernos, los responsables de formular políticas y los administradores de hospitales apoyen a los profesionales sanitarios capacitados que, a su vez, pueden ayudar a las mujeres en el trabajo de parto y el alumbramiento de manera respetuosa.

Uptake of, barriers and enablers to the utilization of postnatal care services in Thyolo, Malawi.

BACKGROUND: Postnatal care (PNC) ensures early assessments for danger signs during the postpartum period and is to be provided within 24 h of birth, 48-72 h, 7-14 days, and six weeks after birth. This study assessed the uptake of and the barriers and facilitators to receiving PNC care among mothers and babies. METHODS: A concurrent mixed-method study employing a retrospective register review and a qualitative descriptive study was conducted in Thyolo from July to December 2020. Postnatal registers of 2019 were reviewed to estimate the proportion of mothers and newborns that received PNC respectively. Focus Group Discussions (FGDs) among postnatal mothers, men, health care workers, and elderly women and in-depth interviews with midwives, and key health care workers were conducted to explore the barriers and enablers to PNC. Observations of the services that mothers and babies received within 24 h of birth, at 48-72 h, 7-14 days, and six weeks after birth were conducted. Descriptive statistics were tabulated for the quantitative data using Stata while the qualitative data were managed using NVivo and analysed following a thematic approach. RESULTS: The uptake of PNC services was at 90.5%, 30.2%, and 6.1% among women and 96.5%, 78.8%, and 13.7% among babies within 48 h of birth, 3 to 7 and 8 to 42 days respectively. The barriers to PNC services included the absence of a baby or mother, limited understanding of PNC services, lack of male involvement, and economic challenges. Cultural and religious beliefs, advice from community members, community activities, distance, lack of resources, and poor attitude of health care workers also impeded the utilisation of PNC services. The enablers included the mother's level of education, awareness of the services, economic resources, community-based health support, adequacy and attitude of health workers, seeking treatment for other conditions, and other clinic activities. CONCLUSION: Optimisation of uptake and utilization of PNC services for mothers and neonates will require the involvement of all stakeholders. The success of PNC services lies in the communities, health services, and mothers understanding the relevance, time points, and services that need to be delivered to create demand for the services. There is a need to assess the contextual factors for a better response in improving the uptake of PNC services and in turn inform the development of strategies for optimizing the uptake of PNC services.

Perspectives of stakeholders regarding the value of maternal and newborn health interventions and practices supported by UNICEF and other partners in the West Nile region of Uganda: a qualitative study.

INTRODUCTION: Uganda has high maternal, neonatal, and under-five mortality rates. This study documents stakeholder perspectives on best practices in a maternal and newborn health (MNH) quality-improvement programme implemented in the West Nile region of Uganda to improve delivery and utilisation of MNH services. METHODS: This exploratory cross-sectional qualitative study, conducted at the end of 2021, captured the perspectives of stakeholders representing the different levels of the healthcare system. Data were collected in four districts through: interviews with key informants working at all levels of the health system; focus group discussions with parents and caretakers and with community health workers; and interviews with individual community members whose lives had been impacted by the MNH programme. The initial content analysis was followed by a deductive synthesis pitched according to the different levels of the health system and the health-systems building blocks. RESULTS: The findings are summarised according to the health-systems building blocks and an account is given of three of the interventions most valued by participants: (1) data use for evidence-based decision making (with regard to human resources, essential reproductive health commodities, and financing); (2) establishment of special newborn care units and high-dependency maternity units at district hospitals and training of the health workforce (also with reference to other infrastructural improvements such as the provision of water, sanitation and hygiene facilities at health facilities); and (3) community referral of pregnant women through a commercial motorcycle voucher referral system. CONCLUSION: The MNH programme in the West Nile region adopted a holistic and system-wide approach to addressing the key bottlenecks in the planning, delivery, and monitoring of quality MNH services. There was general stakeholder appreciation across the board that the interventions had the potential to improve quality of care and newborn and maternal health outcomes. However, as the funding was largely donor-driven, questions about government ownership and sustainability in the context of limited resources remain.

Implementation of distance learning IMCI training in rural districts of Tanzania.

BACKGROUND: The standard face-to-face training for the integrated management of childhood illness (IMCI) continues to be plagued by concerns of low coverage of trainees, the prolonged absence of trainees from the health facility to attend training and the high cost of training. Consequently, the distance learning IMCI training model is increasingly being promoted to address some of these challenges in resource-limited settings. This paper examines participants' accounts of the paper-based IMCI distance learning training programme in three district councils in Mbeya region, Tanzania. METHODS: A cross-sectional qualitative descriptive design was employed as part of an endline evaluation study of the management of possible serious bacterial infection in Busokelo, Kyela and Mbarali district councils of Mbeya Region in Tanzania. Key informant interviews were conducted with purposefully selected policymakers, partners, programme managers and healthcare workers, including beneficiaries and training facilitators. RESULTS: About 60 key informant interviews were conducted, of which 53% of participants were healthcare workers, including nurses, clinicians and pharmacists, and 22% were healthcare administrators, including district medical officers, reproductive and child health coordinators and programme officers. The findings indicate that the distance learning IMCI training model (DIMCI) was designed to address concerns about the standard IMCI model by enhancing efficiency, increasing outputs and reducing training costs. DIMCI included a mix of brief face-to-face orientation sessions, several weeks of self-directed learning, group discussions and brief face-to-face review sessions with facilitators. The DIMCI course covered topics related to management of sick newborns, referral decisions and reporting with nurses and clinicians as the main beneficiaries of the training. The problems with DIMCI included technological challenges related to limited access to proper learning technology (e.g., computers) and unfriendly learning materials. Personal challenges included work-study-family demands, and design and coordination challenges, including low financial incentives, which contributed to participants defaulting, and limited mentorship and follow-up due to limited funding and transport. CONCLUSION: DIMCI was implemented successfully in rural Tanzania. It facilitated the training of many healthcare workers at low cost and resulted in improved knowledge, competence and confidence among healthcare workers in managing sick newborns. However, technological, personal, and design and coordination challenges continue to face learners in rural areas; these will need to be addressed to maximize the success of DIMCI.

Comment: silent burden no more: a global call to action to prioritize perinatal mental health.

Common perinatal mental disorders are the most frequent complications of pregnancy, childbirth and the postpartum period, and the prevalence among women in low- and middle-income countries is the highest at nearly 20%. Women are the cornerstone of a healthy and prosperous society and until their mental health is taken as seriously as their physical wellbeing, we will not improve maternal mortality, morbidity and the ability of women to thrive. On the heels of several international efforts to put perinatal mental health on the global agenda, we propose seven urgent actions that the international community, governments, health systems, academia, civil society, and individuals should take to ensure that women everywhere have access to high-quality, respectful care for both their physical and mental wellbeing. Addressing perinatal mental health promotion, prevention, early intervention and treatment of common perinatal mental disorders must be a global priority.

Antibiotic use for inpatient newborn care with suspected infection: EN-BIRTH multi-country validation study.

BACKGROUND: An estimated 30 million neonates require inpatient care annually, many with life-threatening infections. Appropriate antibiotic management is crucial, yet there is no routine measurement of coverage. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study aimed to validate maternal and newborn indicators to inform measurement of coverage and quality of care. This paper reports validation of reported antibiotic coverage by exit survey of mothers for hospitalized newborns with clinically-defined infections, including sepsis, meningitis, and pneumonia. METHODS: EN-BIRTH study was conducted in five hospitals in Bangladesh, Nepal, and Tanzania (July 2017-July 2018). Neonates were included based on case definitions to focus on term/near-term, clinically-defined infection syndromes (sepsis, meningitis, and pneumonia), excluding major congenital abnormalities. Clinical management was abstracted from hospital inpatient case notes (verification) which was considered as the gold standard against which to validate accuracy of women's report. Exit surveys were conducted using questions similar to The Demographic and Health Surveys (DHS) approach for coverage of childhood pneumonia treatment. We compared survey-report to case note verified, pooled across the five sites using random effects meta-analysis. RESULTS: A total of 1015 inpatient neonates admitted in the five hospitals met inclusion criteria with clinically-defined infection syndromes. According to case note verification, 96.7% received an injectable antibiotic, although only 14.5% of them received the recommended course of at least 7 days. Among women surveyed (n = 910), 98.8% (95% CI: 97.8-99.5%) correctly reported their baby was admitted to a neonatal ward. Only 47.1% (30.1-64.5%) reported their baby's diagnosis in terms of sepsis, meningitis, or pneumonia. Around three-quarters of women reported their baby received an injection whilst in hospital, but 12.3% reported the correct antibiotic name. Only 10.6% of the babies had a blood culture and less than 1% had a lumbar puncture. CONCLUSIONS: Women's report during exit survey consistently underestimated the denominator (reporting the baby had an infection), and even more so the numerator (reporting known injectable antibiotics). Admission to the neonatal ward was accurately reported and may have potential as a contact point indicator for use in household surveys, similar to institutional births. Strengthening capacity and use of laboratory diagnostics including blood culture are essential to promote appropriate use of antibiotics. To track quality of neonatal infection management, we recommend using inpatient records to measure specifics, requiring more research on standardised inpatient records.

Kangaroo mother care: EN-BIRTH multi-country validation study.

BACKGROUND: Kangaroo mother care (KMC) reduces mortality among stable neonates ≤2000 g. Lack of data tracking coverage and quality of KMC in both surveys and routine information systems impedes scale-up. This paper evaluates KMC measurement as part of the Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study. METHODS: The EN-BIRTH observational mixed-methods study was conducted in five hospitals in Bangladesh, Nepal and Tanzania from 2017 to 2018. Clinical observers collected time-stamped data as gold standard for mother-baby pairs in KMC wards/corners. To assess accuracy, we compared routine register-recorded and women's exit survey-reported coverage to observed data, using different recommended denominator options (≤2000 g and ≤ 2499 g). We analysed gaps in quality of provision and experience of KMC. In the Tanzanian hospitals, we assessed daily skin-to-skin duration/dose and feeding frequency. Qualitative data were collected from health workers and data collectors regarding barriers and enablers to routine register design, filling and use. RESULTS: Among 840 mother-baby pairs, compared to observed 100% coverage, both exit-survey reported (99.9%) and register-recorded coverage (92.9%) were highly valid measures with high sensitivity. KMC specific registers outperformed general registers. Enablers to register recording included perceptions of data usefulness, while barriers included duplication of data elements and overburdened health workers. Gaps in KMC quality were identified for position components including wearing a hat. In Temeke Tanzania, 10.6% of babies received daily KMC skin-to-skin duration/dose of ≥20 h and a further 75.3% received 12-19 h. Regular feeding ≥8 times/day was observed for 36.5% babies in Temeke Tanzania and 14.6% in Muhimbili Tanzania. Cup-feeding was the predominant assisted feeding method. Family support during admission was variable, grandmothers co-provided KMC more often in Bangladesh. No facility arrangements for other family members were reported by 45% of women at exit survey. CONCLUSIONS: Routine hospital KMC register data have potential to track coverage from hospital KMC wards/corners. Women accurately reported KMC at exit survey and evaluation for population-based surveys could be considered. Measurement of content, quality and experience of KMC need consensus on definitions. Prioritising further KMC measurement research is important so that high quality data can be used to accelerate scale-up of high impact care for the most vulnerable.

Exploring and prioritising strategies for improving uptake of postnatal care services in Thyolo, Malawi: A qualitative study.

Although postnatal care services form a critical component of the cascade of care in maternal, newborn, and child health the uptake of these services has remained low worldwide. This study explored and prioritised the strategies for optimising the uptake of postnatal care (PNC) services in Malawi. A qualitative descriptive study followed by nominal group techniques was conducted at three health facilities in Malawi from July to December 2020 and in October 2021. We conducted focus group discussions among postnatal mothers, fathers, healthcare workers, elderly women, and grandmothers. We conducted in-depth interviews with midwives and key health managers. Nominal group techniques were used to prioritise the main strategies for the provision of PNC. The demand strategies include appointment date reminders, provision of free health passport books, community awareness campaigns, and involvement of men in the services. The supply strategies included training health providers, improving clinic operations: task-shifting and hours of operation, having infrastructure for the services, and linkage to other services. Having services delivered near end-user residences was a crosscutting strategy. Refresher training and improvement in the clinic operations especially on hours of operation, appointment date reminders, and linkage to care were the prioritised strategies. There is a need to use acceptable and contextualised strategies to optimise the uptake and delivery of postnatal care services. Educating the healthcare workers and the community on postnatal services is key to increasing the demand and supply of the services.

Engaging the private sector to deliver quality maternal and newborn health services for universal health coverage: lessons from policy dialogues.

The private health sector is becoming increasingly important in discussions on improving the quality of care for maternal and newborn health (MNH). Yet information rarely addresses what engaging the private sector for MNH means and how to do it. In 2019, the Network for Improving Quality of Care for Maternal, Newborn and Child Health (the Network) initiated exploratory research to better understand how to ensure that the private sector delivers quality care and what the public sector must do to facilitate and sustain this process. This article details the approach and lessons learnt from two Network countries, Ghana and Nigeria, where teams explored the mechanisms for engaging the private sector in delivering MNH services with quality. The situational analyses in Ghana and Nigeria revealed challenges in engaging the private sector, including lack of accurate data, mistrust and an unlevel playing field. Challenging market conditions hindered a greater private sector role in delivering quality MNH services. Based on these analyses, participants at multistakeholder workshops recommended actions addressing policy/administration, regulation and service delivery. The findings from this research help strengthen the evidence base on engaging the private sector to deliver quality MNH services and show that this likely requires engagement with broader health systems factors. In recognition of this need for a balanced approach and the new WHO private sector strategy, the WHO has updated the tools and process for countries interested in conducting this research. The Nigerian Ministry of Health is stewarding additional policy dialogues to further engage the private sector.

Implementing maternal and newborn health quality of care standards in healthcare facilities to improve the adoption of respectful maternity care in Bangladesh, Ghana and Tanzania: a controlled before and after study.

INTRODUCTION: Many women worldwide cannot access respectful maternity care (RMC). We assessed the effect of implementing maternal and newborn health (MNH) quality of care standards on RMC measures. METHODS: We used a facility-based controlled before and after design in 43 healthcare facilities in Bangladesh, Ghana and Tanzania. Interviews with women and health workers and observations of labour and childbirth were used for data collection. We estimated difference-in-differences to compare changes in RMC measures over time between groups. RESULTS: 1827 women and 818 health workers were interviewed, and 1512 observations were performed. In Bangladesh, MNH quality of care standards reduced physical abuse (DiD -5.2;-9.0 to -1.4). The standards increased RMC training (DiD 59.0; 33.4 to 84.6) and the availability of policies and procedures for both addressing patient concerns (DiD 46.0; 4.7 to 87.4) and identifying/reporting abuse (DiD 45.9; 19.9 to 71.8). The control facilities showed greater improvements in communicating the delivery plan (DiD -33.8; -62.9 to -4.6). Other measures improved in both groups, except for satisfaction with hygiene. In Ghana, the intervention improved women's experiences. Providers allowed women to ask questions and express concerns (DiD 37.5; 5.9 to 69.0), considered concerns (DiD 14.9; 4.9 to 24.9), reduced verbal abuse (DiD -8.0; -12.1 to -3.8) and physical abuse (DiD -5.2; -11.4 to -0.9). More women reported they would choose the facility for another delivery (DiD 17.5; 5.5 to 29.4). In Tanzania, women in the intervention facilities reported improvements in privacy (DiD 24.2; 0.2 to 48.3). No other significant differences were observed due to improvements in both groups. CONCLUSION: Institutionalising care standards and creating an enabling environment for quality MNH care is feasible in low and middle-income countries and may facilitate the adoption of RMC.

Institutionalising maternal and newborn quality-of-care standards in Bangladesh, Ghana and Tanzania: a quasi-experimental study.

INTRODUCTION: Facility interventions to improve quality of care around childbirth are known but need to be packaged, tested and institutionalised within health systems to impact on maternal and newborn outcomes. METHODS: We conducted cross-sectional assessments at baseline (2016) and after 18 months of provider-led implementation of UNICEF/WHO's Every Mother Every Newborn Quality Improvement (EMEN-QI) standards (preceding the WHO Standards for improving quality of maternal and newborn care in health facilities). 19 hospitals and health centres (2.8M catchment population) in Bangladesh, Ghana and Tanzania were involved and 24 from adjoining districts served for 'comparison'. We interviewed 43 facility managers and 818 providers, observed 1516 client-provider interactions, reviewed 12 020 records and exit-interviewed 1826 newly delivered women. We computed a 39-criteria institutionalisation score combining clinical, patient rights and cross-cutting domains from EMEN-QI and used routine/District Health Information System V.2 data to assess the impact on perinatal and maternal mortality. RESULTS: EMEN-QI standards institutionalisation score increased from 61% to 80% during EMEN-QI implementation, exceeding 75% target. All mortality indicators showed a downward trajectory though not all reached statistical significance. Newborn case-fatality rate fell significantly by 25% in Bangladesh (RR=0·75 (95% CI=0·59 to 0·96), p=0·017) and 85% in Tanzania (RR=0.15 (95% CI=0.08 to 0.29), p<0.001), but not in Ghana. Similarly, stillbirth (RR=0.64 (95% CI=0.45 to 0.92), p<0.01) and perinatal mortality in Tanzania reduced significantly (RR=0.59 (95% CI=0.40 to 0.87), p=0.007). Institutional maternal mortality ratios generally reduced but were only significant in Ghana: 362/100 000 to 207/100 000 livebirths (RR=0.57 (95% CI=0.33 to 0.99), p=0.046). Routine mortality data from comparison facilities were limited and scarce. Systematic death audits and clinical mentorship drove these achievements but challenges still remain around human resource management and equipment maintenance systems. CONCLUSION: Institutionalisation of the UNICEF/WHO EMEN-QI standards as a package is feasible within existing health systems and may reduce mortality around childbirth. Critical gaps around sustainability must be fundamental considerations for scale-up.

Progress and barriers towards maternal and neonatal tetanus elimination in the remaining 12 countries: a systematic review.

This systematic review assessed the progress and barriers towards maternal and neonatal tetanus elimination in the 12 countries that are yet to achieve elimination, globally. Coverage of at least 80% (the coverage level required for elimination) was assessed among women of reproductive age for five factors: (1) at least two doses of tetanus toxoid-containing vaccine, (2) protection at birth, (3) skilled birth attendance, (4) antenatal care visits, and (5) health facility delivery. A scoping review of the literature and data from Demographic and Health Surveys and Multiple Indicator Cluster Surveys provided insights into the barriers to attaining maternal and neonatal tetanus elimination. Findings showed that none of the 12 countries attained at least 80% coverage for women of reproductive age receiving at least two doses of tetanus toxoid-containing vaccine or protection at birth according to the data from Demographic and Health Surveys or Multiple Indicator Cluster Surveys. Barriers to maternal and neonatal tetanus elimination were mostly related to health systems and socioeconomic factors. Modification to existing maternal and neonatal tetanus elimination strategies, including innovations, will be required to accelerate maternal and neonatal tetanus elimination in these countries.

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.