Infection prevention and control and related practices in African neonatal units: The Pan-African neonatal care assessment study (PANCAS).

BACKGROUND: The burden of neonatal mortality is primarily borne by low- and middle-income countries (LMICs), including deaths due to healthcare-associated infections (HAIs). Few studies have assessed infection prevention and control (IP&C) practices in African units caring for small and/or sick newborns aimed to reduce HAIs. METHODS: We performed a mixed-methods study composed of a survey and virtual tour to assess IP&C and related practices. We created a survey composed of multiple-choice and open-ended questions delivered to site respondents via Zoom or video equivalent. Respondents provided a virtual tour of their unit via video and the study team used a checklist to evaluate specific practices. RESULTS: We recruited 45 units caring for small and sick newborns in 20 African countries. Opportunities to optimize hand hygiene, Water, Sanitation and Hygiene (WASH) practices, Kangaroo Mother Care, and IP&C training were noted. The virtual tour offered further understanding of IP&C challenges unique to individual sites. All respondents expressed the need for additional space, equipment, supplies, education, and IP&C staff and emphasized that attention to maternal comfort was important to IP&C success. DISCUSSION: This study identified opportunities to improve IP&C practices using low-cost measures including further education and peer support through learning collaboratives. Virtual tours can be used to provide site-specific assessment and feedback from peers, IP&C specialists and environmental engineering experts.

Delayed and Interrupted Ventilation with Excess Suctioning after Helping Babies Breathe with Congolese Birth Attendants.

There is a substantial gap in our understanding of resuscitation practices following Helping Babies Breathe (HBB) training. We sought to address this gap through an analysis of observed resuscitations following HBB 2nd edition training in the Democratic Republic of the Congo. This is a secondary analysis of a clinical trial evaluating the effect of resuscitation training and electronic heart rate monitoring on stillbirths. We included in-born, liveborn neonates ≥28 weeks gestation whose resuscitation care was directly observed and documented. For the 2592 births observed, providers dried/stimulated before suctioning in 97% of cases and suctioned before ventilating in 100%. Only 19.7% of newborns not breathing well by 60 s (s) after birth ever received ventilation. Providers initiated ventilation at a median 347 s (>five minutes) after birth; no cases were initiated within the Golden Minute. During 81 resuscitations involving ventilation, stimulation and suction both delayed and interrupted ventilation with a median 132 s spent drying/stimulating and 98 s suctioning. This study demonstrates that HBB-trained providers followed the correct order of resuscitation steps. Providers frequently failed to initiate ventilation. When ventilation was initiated, it was delayed and interrupted by stimulation and suctioning. Innovative strategies targeting early and continuous ventilation are needed to maximize the impact of HBB.

Adaptation of Essential Care for Every Baby educational program to improve infant outcomes in the context of Zika.

BACKGROUND: The outbreak and ongoing transmission of Zika virus provided an opportunity to strengthen essential newborn care and early childhood development systems through collaboration with the US Agency for International Development Applying Science to Strengthen and Improve Systems (USAID ASSIST). The objective was to create a system of sustainable training dissemination which improves newborn care-related quality indicators in the context of Zika. METHODS: From 2018-19, USAID ASSIST supported a series of technical assistance visits by the American Academy of Pediatrics (AAP) in four Caribbean countries to strengthen the clinical capacity in care of children potentially affected by Zika through dissemination of Essential Care for Every Baby (ECEB), teaching QI methodology, coaching visits, and development of clinical care guidelines. ECEB was adapted to emphasize physical exam findings related to Zika. The first series of workshops were facilitated by AAP technical advisors and the second series were facilitated by the newly trained local champions. Quality of care was monitored with performance indicators at 134 health facilities. RESULTS: A repeated measures (pre-post) ANOVA was conducted, revealing significant pre-post knowledge gains [F(1) = 197.9, p < 0.001] on knowledge check scores. Certain performance indicators related to ECEB practices demonstrated significant changes and midline shift on the run chart in four countries. CONCLUSION: ECEB can be adapted to incorporate important local practices, causes of neonatal morbidity and mortality, and differing healthcare system structures, which, as one part of a larger technical assistance package, leads to improved performance of health systems.

Perceptions and experiences of Congolese midwives implementing a low-cost battery-operated heart rate meter during newborn resuscitation.

Background: 900,000 newborns die from respiratory depression each year; nearly all of these deaths occur in low- and middle-income countries. Deaths from respiratory depression are reduced by evidence-based resuscitation. Electronic heart rate monitoring provides a sensitive indicator of the neonate's status to inform resuscitation care, but is infrequently used in low-resource settings. In a recent trial in the Democratic Republic of the Congo, midwives used a low-cost, battery-operated heart rate meter (NeoBeat) to continuously monitor heart rate during resuscitations. We explored midwives' perceptions of NeoBeat including its utility and barriers and facilitators to use. Methods: After a 20-month intervention in which midwives from three facilities used NeoBeat during resuscitations, we surveyed midwives and conducted focus group discussions (FGDs) regarding the incorporation of NeoBeat into clinical care. FGDs were conducted in Lingala, the native language, then transcribed and translated from Lingala to French to English. We analyzed data by: (1) coding of transcripts using Nvivo, (2) comparison of codes to identify patterns in the data, and (3) grouping of codes into categories by two independent reviewers, with final categories determined by consensus. Results: Each midwife from Facility A used NeoBeat on an estimated 373 newborns, while each midwife at facilities B and C used NeoBeat an average 24 and 47 times, respectively. From FGDs with 30 midwives, we identified five main categories of perceptions and experiences regarding the use of NeoBeat: (1) Providers' initial skepticism evolved into pride and a belief that NeoBeat was essential to resuscitation care, (2) Providers viewed NeoBeat as enabling their resuscitation and increasing their capacity, (3) NeoBeat helped providers identify flaccid newborns as liveborn, leading to hope and the perception of saving of lives, (4) Challenges of use of NeoBeat included cleaning, charging, and insufficient quantity of devices, and (5) Providers desired to continue using the device and to expand its use beyond resuscitation and their own facilities. Conclusion: Midwives perceived that NeoBeat enabled their resuscitation practices, including assisting them in identifying non-breathing newborns as liveborn. Increasing the quantity of devices per facility and developing systems to facilitate cleaning and charging may be critical for scale-up.

Role of Pediatricians, Pediatric Associations, and Academic Departments in Ensuring Optimal Early Childhood Development Globally: Position Paper of the International Pediatric Association.

ABSTRACT: Early childhood (birth-8 years), particularly the first 3 years, is the most critical time in development because of the highly sensitive developing brain. Providing appropriate developmental care (i.e., nurturing care, as defined by the World Health Organization [WHO]) during early childhood is key to ensuring a child's holistic development. Pediatricians are expected to play a critical role in supporting early childhood development (ECD) through providing developmental services such as developmental monitoring, anticipatory guidance, screening, and referral to medical and/or community-based services when delay is identified. Pediatricians are also expected to serve as advocates within their clinics and communities for improved delivery of ECD services, such as advocating for increasing funding for ECD initiatives, increasing insurance coverage of ECD services, and working to increase other pediatricians' awareness of the principles of ECD and how to deliver developmental services. However, this does not always occur. Typically, pediatricians' training and practice emphasizes treating disease rather than enhancing ECD. Pediatricians are further hindered by a lack of uniformity across nations in guidelines for developmental monitoring and screening. In this article, we present the vision of the International Pediatric Association (IPA) of the roles that pediatricians, academic departments, medical training programs, and pediatric associations should fulfill to help support ECD, including raising ECD to higher levels of priority in routine pediatric care. First, we present the challenges that face these goals in supporting ECD. We then propose, with supportive literature, strategies and resources to overcome these challenges in collaboration with local and international stakeholders, including the IPA, the WHO, UNICEF, and the World Bank.

Effect of Training Healthcare Providers in Helping Babies Breathe Program on Neonatal Mortality Rates.

Background: Training in the Helping Babies Breathe (HBB) Program has been associated with a reduction in early neonatal mortality rate (ENMR), the neonatal mortality rate (NMR), and fresh stillbirth rate (FSBR) in low- and middle-income countries (LMICs). This program was implemented in five different healthcare facilities in the Oliver Reginald Tambo (ORT) District, South Africa from September 2015 to December 2020. Objective: To determine and compare the FSBR, ENMR, and NMR between 2015 before initiation of the program (baseline) and subsequent years up to 2020 following the implementation of facility-based training of HBB in five hospitals in ORT District. Methods: Records of perinatal statistics from January 2015 to December 2020 were reviewed to calculate FSBR, ENMR, and NMR. Data were collected from the five healthcare facilities which included two district hospitals (Hospital A&B), two regional hospitals (Hospital C&D), and one tertiary hospital (Hospital E). Comparisons were made between pre- (2015) and post- (2016-2020) HBB implementation periods. Differences in changes over time were also assessed using linear regression analysis. Results: There were 19,275 births in 2015, increasing to 22,192 in 2020 with the majority (55.3%) of births occurring in regional hospitals. There were significant reductions in ENMR (OR-0.78, 95% CI 0.70-0.87) and NMR (OR-0.81, 95% CI 0.73-0.90), but not in FSBR, in the five hospitals combined when comparing the two time periods. Significant reduction was also noted in trends over time in ENMR (r 2 = 0.45, p = 0.001) and NMR (r 2 = 0.23, p = 0.026), but not in FSBR (r 2 = 0.0, p = 0.984) with all hospitals combined. In looking at individual hospitals, Hospital A (r 2 = 0.61, p < 0.001) and Hospital E (r 2 = 0.19, p = 0.048) showed a significant reduction in ENMR over time, but there were no significant changes in all mortality rates for Hospitals B, C, and D, and for the district or regional hospitals combined. Conclusion: There was an overall reduction of 22% and 19% in ENMR and NMR, respectively, from pre- to post-HBB implementation periods, although there were variations from year to year over the 5-year period and, across hospitals. These differences suggest that there were other factors that affected the perinatal/neonatal outcomes in the hospital sites in addition to the implementation of training in HBB.

Telementoring initiative for newborn care providers in Kenya, Pakistan and Tanzania.

OBJECTIVES: To support governments' efforts at neonatal mortality reduction, UNICEF and the American Academy of Pediatrics launched a telementoring project in Kenya, Pakistan and Tanzania. METHODS: In Fall 2019, an individualised 12-session telementoring curriculum was created for East Africa and Pakistan after site visits that included care assessment, patient data review and discussion with faculty and staff. After the programme, participants, administrators and UNICEF staff were surveyed and participated in focus group discussions. RESULTS: Participants felt the programme improved knowledge and newborn care. Qualitative analysis found three common themes of successful telementoring: local buy-in, use of existing training or clinical improvement structures, and consideration of technology needs. CONCLUSIONS: Telementoring has potential as a powerful tool in newborn education. It offers more flexibility and easier access than in-person sessions. This project has the potential for scale-up, particularly when physical distancing and travel restrictions are the norm.

Effect of resuscitation training and implementation of continuous electronic heart rate monitoring on identification of stillbirth.

AIM: To evaluate the effect of resuscitation training and continuous electronic heart rate (HR) monitoring of non-breathing newborns on identification of stillbirth. METHODS: We conducted a pre-post interventional trial in three health facilities in the Democratic Republic of the Congo. We collected data on a retrospective control group of newborns that reflected usual resuscitation practice (Epoch 1). In the prospective, interventional group, skilled birth attendants received resuscitation training in Helping Babies Breathe and implemented continuous electronic HR monitoring of non-breathing newborns (Epoch 2). Our primary outcome was the incidence of stillbirth with secondary outcomes of fresh or macerated stillbirth, neonatal death before discharge and perinatal death. Among a subset, we conducted expert review of electronic HR data to estimate misclassification of stillbirth in Epoch 2. We used a generalized estimating equation, adjusted for variation within-facility, to compare risks between EPOCHs. RESULTS: There was no change in total stillbirths following resuscitation training and continuous electronic HR monitoring of non-breathing newborns (aRR 1.15 [0.95, 1.39]). We observed an increased rate of macerated stillbirth (aRR 1.58 [1.24, 2.02]), death before discharge (aRR 3.31 [2.41, 4.54]), and perinatal death (aRR 1.61 [1.38, 1.89]) during the intervention period. In expert review, 20% of newborns with electronic HR data that were classified by SBAs as stillborn were liveborn. CONCLUSION: Resuscitation training and use of continuous electronic HR monitoring did not reduce stillbirths nor eliminate misclassification.

Chlamydia, Gonorrhea, and Incident HIV Infection During Pregnancy Predict Preterm Birth Despite Treatment.

BACKGROUND: Identifying predictors of preterm birth (PTB) in high-burden regions is important as PTB is the leading cause of global child mortality. METHODS: This analysis was nested in a longitudinal study of human immunodeficiency virus (HIV) incidence in Kenya. HIV-seronegative women enrolled in pregnancy had nucleic acid amplification tests (chlamydia and gonorrhea), rapid plasma reagin (syphilis), wet mount microscopy (Trichomonas and yeast), and Gram stain (bacterial vaginosis); sexually transmitted infection (STI) treatment was provided. PTB predictors were determined using log-binomial regression. RESULTS: Among 1244 mothers of liveborn infants, median gestational age at enrollment was 26 weeks (IQR, 22-31), and at delivery was 39.1 weeks (IQR, 37.1-40.9). PTB occurred in 302 women (24.3%). Chlamydia was associated with a 1.59-fold (P = .006), gonorrhea a 1.62-fold (P = .04), and incident HIV a 2.08-fold (P = .02) increased PTB prevalence. Vaginal discharge and cervical inflammation were associated with PTB, as were age ≤21 (prevalence ratio [PR] = 1.39, P = .001) and any STI (PR = 1.47, P = .001). Associations with chlamydia and incident HIV remained in multivariable models. CONCLUSIONS: STIs and incident HIV in pregnancy predicted PTB despite treatment, suggesting the need for earlier treatment and interventions to decrease genital inflammation.

Helping Babies Breathe Global Development Alliance and the Power of Partnerships.

The Helping Babies Breathe Global Development Alliance (GDA) was a public-private partnership created simultaneously with the launch of the educational program Helping Babies Breathe to accelerate dissemination and implementation of neonatal resuscitation in low- and middle-income countries with the goal of reducing the global burden of neonatal mortality and morbidity related to birth asphyxia. Representatives from 6 organizations in the GDA highlight the recognized needs that motivated their participation and how they built on one another's strengths in resuscitation science and education, advocacy, frontline implementation, health system strengthening, and implementation research to achieve common goals. Contributions of time, talent, and financial resources from the community, government, and private corporations and foundations powered an initiative that transformed the landscape for neonatal resuscitation in low- and middle-income countries. The organizations describe the power of partnerships, the challenges they faced, and how each organization was shaped by the collaboration. Although great progress was achieved, lessons learned through the GDA and additional efforts must still be applied to the remaining challenges of prevention, widespread implementation, improvement in the quality of care, and sustainable integration of neonatal resuscitation and essential newborn care into the fabric of health care systems.

Global immunization systems strengthening through pediatric societies: the promise of private-public partnerships in Indonesia.

Vaccines are one of the most successful health interventions in history. Yet, vaccine-preventable diseases still claim the lives of 2.5 million individuals globally every year. Approximately 60% of the 19.4 million infants that did not have access to routine immunization services in 2018 live in 10 countries, one of which is Indonesia. In order to reach global targets, it is critical for countries such as Indonesia to prioritize, tailor, and operationalize vaccination strategies to address immunization gaps. Pediatricians and national pediatric societies (NPS) are trusted stakeholders in their countries and are uniquely qualified to promote vaccination programs. The American Academy of Pediatrics (AAP) partnered with the Indonesian Pediatric Society (IPS), with support from the US Centers for Disease Control and Prevention (CDC), to initiate a multiyear project to build the capacity of IPS, individual members, and other child health clinicians to strategically advocate for improved immunization services across both public and private sectors.

Major causes of death in preterm infants in selected hospitals in Ethiopia (SIP): a prospective, cross-sectional, observational study.

BACKGROUND: Neonatal deaths now account for 47% of all deaths in children younger than 5 years globally. More than a third of newborn deaths are due to preterm birth complications, which is the leading cause of death. Understanding the causes and factors contributing to neonatal deaths is needed to identify interventions that will reduce mortality. We aimed to establish the major causes of preterm mortality in preterm infants in the first 28 days of life in Ethiopia. METHODS: We did a prospective, cross-sectional, observational study in five hospitals in Ethiopia. Study participants were preterm infants born in the study hospitals at younger than 37 gestational weeks. Infants whose gestational age could not be reliably estimated and those born as a result of induced abortion were excluded from the study. Data were collected on maternal and obstetric history, clinical maternal and neonatal conditions, and laboratory investigations. For neonates who died of those enrolled, consent was requested from parents for post-mortem examinations (both complete diagnostic autopsy and minimally invasive tissue sampling). An independent panel of experts established the primary and contributory causes of preterm mortality with available data. FINDINGS: Between July 1, 2016, to May 31, 2018, 4919 preterm infants were enrolled in the study and 3852 were admitted to neonatal intensive care units. By 28 days of post-natal age, 1109 (29%) of those admitted to the neonatal intensive care unit died. Complete diagnostic autopsy was done in 441 (40%) and minimally invasive tissue sampling in 126 (11%) of the neonatal intensive care unit deaths. The main primary causes of death in the 1109 infants were established as respiratory distress syndrome (502 [45%]); sepsis, pneumonia and meningitis (combined as neonatal infections; 331 [30%]), and asphyxia (151 [14%]). Hypothermia was the most common contributory cause of preterm mortality (770 [69%]). The highest mortality occurred in infants younger than 28 weeks of gestation (89 [86%] of 104), followed by infants aged 28-31 weeks (512 [54%] of 952), 32-34 weeks (349 [18%] of 1975), and 35-36 weeks (159 [8%] of 1888). INTERPRETATION: Three conditions accounted for 89% of all deaths among preterm infants in Ethiopia. Scale-up interventions are needed to prevent or treat these conditions. Further research is required to develop effective and affordable interventions to prevent and treat the major causes of preterm death. FUNDING: Bill & Melinda Gates Foundation.

Criteria for assigning cause of death for stillbirths and neonatal deaths in research studies in low-middle income countries.

Accurate knowledge regarding cause of death (COD) for stillbirths and neonatal deaths is crucial, especially in low-income countries, in order for public health and medical officials to choose appropriate interventions likely to reduce these deaths. To date, many of the COD studies in these areas have relied only on obstetric or neonatal clinical information and the determination of COD is likely to be inaccurate. Information related to infectious COD is especially lacking. Thus, without more sophisticated testing, data as currently collected only provide a very weak approximation of the COD and may well lead to adoption of interventions of limited usefulness. In this commentary, we propose recommendations regarding the type of data needed to determine with reasonable accuracy the COD for stillbirths and neonatal deaths in low-resource settings. Using these data, and a method to determine the degree of certainty, we then propose definitions for the most common COD. Our goal is to reduce subjectivity and provide more specificity for the tests used in existing classification systems so that the methodology of COD determination is transparent and able to be replicated over time and from location to location.

The project to understand and research preterm pregnancy outcomes and stillbirths in South Asia (PURPOSe): a protocol of a prospective, cohort study of causes of mortality among preterm births and stillbirths.

BACKGROUND: In South Asia, where most stillbirths and neonatal deaths occur, much remains unknown about the causes of these deaths. About one-third of neonatal deaths are attributed to prematurity, yet the specific conditions which cause these deaths are often unclear as is the etiology of stillbirths. In low-resource settings, most women are not routinely tested for infections and autopsy is rare. METHODS: This prospective, cohort study will be conducted in hospitals in Davengere, India and Karachi, Pakistan. All women who deliver either a stillbirth or a preterm birth at one of the hospitals will be eligible for enrollment. With consent, the participant and, when applicable, her offspring, will be followed to 28-days post-delivery. A series of research tests will be conducted to determine infection and presence of other conditions which may contribute to the death. In addition, all routine clinical investigations will be documented. For both stillbirths and preterm neonates who die ≤ 28 days, with consent, a standard autopsy as well as minimally invasive tissue sampling will be conducted. Finally, an expert panel will review all available data for stillbirths and neonatal deaths to determine the primary and contributing causes of death using pre-specified guidance. CONCLUSION: This will be among the first studies to prospectively obtain detailed information on causes of stillbirth and preterm neonatal death in low-resource settings in Asia. Determining the primary causes of death will be important to inform strategies most likely to reduce the high mortality rates in South Asia. TRIAL REGISTRATION: Clinicaltrials.gov ( NCT03438110 ) Clinical Trial Registry of India ( CTRI/2018/03/012281 ).

A Prospective Study of Causes of Illness and Death in Preterm Infants in Ethiopia: The SIP Study Protocol.

BACKGROUND: With nearly 15 million annual preterm births globally, preterm birth is the most common cause of neonatal death. Forty to 60 % of neonatal deaths are directly or indirectly associated with preterm mortality. As countries aim to meet the Sustainable Development Goals to reduce neonatal mortality, significant reductions in preterm mortality are needed. This study aims to identify the common causes of preterm illness and their contribution to preterm mortality in low-resource settings. This article will describe the methods used to undertake the study. METHODS: This is a prospective, multi-centre, descriptive clinical study. Socio-demographic, obstetric, and maternal factors, and clinical and laboratory findings will be documented. The major causes of preterm mortality will be identified using clinical, laboratory, imaging, and autopsy methods and use the national Ethiopian guidelines on management of preterm infants including required investigations to reach final diagnoses. The study will document the clinical and management protocols followed in these settings. The approach consists of clinical examinations and monitoring, laboratory investigations, and determination of primary and contributory causes of mortality through both clinical means and by post-mortem examinations. An independent panel of experts will validate the primary and contributory causes of mortality. To obtain the estimated sample size of 5000 preterm births, the study will be undertaken in five hospitals in three regions of Ethiopia, which are geographically distributed across the country. All preterm infants who are either born or transferred to these hospitals will be eligible for the study. Three methods (last menstrual period, physical examination using the New Ballard Score, and ultrasound) will be used to determine gestational age. All clinical procedures will be conducted per hospital protocol and informed consent will be taken from parents or caretakers prior to their participation in the study as well as for autopsy if the infant dies. DISCUSSION: This study will determine the major causes of death and illness among hospitalized preterm infants in a low-resource setting. The result will inform policy makers and implementers of areas that can be prioritized in order to contribute to a significant reduction in neonatal mortality.

Consensus-based approach to develop a measurement framework and identify a core set of indicators to track implementation and progress towards effective coverage of facility-based Kangaroo Mother Care.

BACKGROUND: As efforts to scale up the delivery of Kangaroo Mother Care (KMC) in facilities are increasing, a standardized approach to measure implementation and progress towards effective coverage is needed. Here, we describe a consensus-based approach to develop a measurement framework and identify a core set of indicators for monitoring facility-based KMC that would be feasible to measure within existing systems. METHODS: The KMC measurement framework and core list of indicators were developed through: 1) scoping exercise to identify potential indicators through literature review and requests from researchers and program implementers; and 2) face-to-face consultations with KMC and measurement experts working at country and global levels to review candidate indicators and finalize selection and definitions. RESULTS: The KMC measurement framework includes two main components: 1) service readiness, based on the WHO building blocks framework; and 2) service delivery action sequence covering identification, service initiation, continuation to discharge, and follow-up to graduation. Consensus was reached on 10 core indicators for KMC, which were organized according to the measurement framework. We identified 4 service readiness indicators, capturing national level policy for KMC, availability of KMC indicators in HMIS, costed operational plans for KMC and availability of KMC services at health facilities with inpatient maternity services. Six indicators were defined for service delivery, including weighing of babies at birth, identification of those ≤2000 g, initiation of facility-based KMC, monitoring the quality of KMC, status of babies at discharge from the facility and levels of follow-up (according to country-specific protocol). CONCLUSIONS: These core KMC indicators, identified with input from a wide range of global and country-level KMC and measurement experts, can aid efforts to strengthen monitoring systems and facilitate global tracking of KMC implementation. As data collection systems advance, we encourage program managers and evaluators to document their experiences using this framework to measure progress and allow indicator refinement, with the overall aim of working towards sustainable, country-led data systems.

Antenatal corticosteroids for women at risk of imminent preterm birth in low-resource countries: the case for equipoise and the need for efficacy trials.

The scientific basis for antenatal corticosteroids (ACS) for women at risk of preterm birth has rapidly changed in recent years. Two landmark trials-the Antenatal Corticosteroid Trial and the Antenatal Late Preterm Steroids Trial-have challenged the long-held assumptions on the comparative health benefits and harms regarding the use of ACS for preterm birth across all levels of care and contexts, including resource-limited settings. Researchers, clinicians, programme managers, policymakers and donors working in low-income and middle-income countries now face challenging questions of whether, where and how ACS can be used to optimise outcomes for both women and preterm newborns. In this article, we briefly present an appraisal of the current evidence around ACS, how these findings informed WHO's current recommendations on ACS use, and the knowledge gaps that have emerged in the light of new trial evidence. Critical considerations in the generalisability of the available evidence demonstrate that a true state of clinical equipoise exists for this treatment option in low-resource settings. An expert group convened by WHO concluded that there is a clear need for more efficacy trials of ACS in these settings to inform clinical practice.

Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE-NI): an extension of the STROBE statement for neonatal infection research.

Neonatal infections are estimated to account for a quarter of the 2·8 million annual neonatal deaths, as well as approximately 3% of all disability-adjusted life-years. Despite this burden, few data are available on incidence, aetiology, and outcomes, particularly regarding impairment. We aimed to develop guidelines for improved scientific reporting of observational neonatal infection studies, to increase comparability and to strengthen research in this area. This checklist, Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE- NI), is an extension of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement. STROBE-NI was developed following systematic reviews of published literature (1996-2015), compilation of more than 130 potential reporting recommendations, and circulation of a survey to relevant professionals worldwide, eliciting responses from 147 professionals from 37 countries. An international consensus meeting of 18 participants (with expertise in infectious diseases, neonatology, microbiology, epidemiology, and statistics) identified priority recommendations for reporting, additional to the STROBE statement. Implementation of these STROBE-NI recommendations, and linked checklist, aims to improve scientific reporting of neonatal infection studies, increasing data utility and allowing meta-analyses and pathogen-specific burden estimates to inform global policy and new interventions, including maternal vaccines.