Fractional Doses of Pneumococcal Conjugate Vaccine - A Noninferiority Trial.

BACKGROUND: Pneumococcal conjugate vaccines are an expensive component of the routine immunization schedule. Fractional-dose regimens may be one option to increase the sustainability of the vaccine program. METHODS: We assessed whether the immunogenicity of fractional doses of the 10-valent and 13-valent pneumococcal conjugate vaccines (PCV10 [GSK] and PCV13 [Pfizer], respectively) would be noninferior to that of the full doses and analyzed the prevalence of vaccine-serotype carriage. We randomly assigned healthy infants in Kenya to one of seven equal-sized trial groups. Participants in groups A through F were assigned to receive either a fractional or full dose of PCV10 or PCV13, administered as two primary doses plus one booster dose. In group A, participants received a full dose of PCV13; group B, a 40% dose of PCV13; group C, a 20% dose of PCV13; group D, a full dose of PCV10; group E, a 40% dose of PCV10; and group F, a 20% dose of PCV10. Participants in the seventh group (group G) received a full dose of PCV10 as three primary doses without a booster. Immunogenicity was assessed 4 weeks after the primary series of doses and 4 weeks after the booster dose. Noninferiority could be declared 4 weeks after the primary series if the difference in the percentage of participants with a threshold response was not more than 10% and 4 weeks after administration of the booster if the ratio of the geometric mean concentration (GMC) of IgG was more than 0.5. A vaccine dose was prespecified as noninferior if it met the noninferiority criterion for at least 8 of the 10 vaccine types in the PCV10 groups or at least 10 of the 13 vaccine types in the PCV13 groups. Carriage was assessed when participants were 9 months and 18 months of age. RESULTS: In the per-protocol analysis, 40% of a full dose of PCV13 met the noninferiority criterion for 12 of 13 serotypes after the primary series and for 13 of 13 serotypes after the booster. The immunogenicity of the 20% dose of PCV13 and of the 40% and 20% doses of PCV10 was not noninferior to that of the full doses. Vaccine serotype-type carriage prevalence was similar across the PCV13 groups at 9 months and 18 months of age. CONCLUSIONS: In a three-dose schedule (two primary doses and a booster), 40% doses of PCV13 were noninferior to full doses for all included serotypes. Lower doses of PCV13 and PCV10 did not meet the criteria for noninferiority. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov number, NCT03489018; Pan African Clinical Trial Registry number, PACTR202104717648755.).

Mechanisms associated with maternal adverse childhood experiences on offspring's mental health in Nairobi informal settlements: a mediational model testing approach.

BACKGROUND: Adverse childhood experiences (ACEs) is a significant public health and social welfare problem in low-and middle income countries (LMICs). However, most ACEs research is based on developed countries, and little is known about mechanisms of early ACEs on adulthood health and offspring's wellbeing for populations in LMICs. This area is needed to guide social welfare policy and intervention service planning. This study addresses these research gaps by examining patterns of ACEs and understanding the role of ACEs on adulthood health (i.e., physical, mental health, experience of underage pregnancy) and offspring's mental health in Kenya. The study was guided by an Integrated Family Stress and Adverse Childhood Experiences Mediation Framework. METHODS: Three hundred ninety four mothers from two informal communities in Kariobangi and Kangemi in Nairobi were included in this study. The Adverse Childhood Experiences International Questionnaire (ACE-IQ), the Kessler Psychological Distress Scale (K10), Overall Health and Quality of Life items, and Child Behavior Checklist were used to study research questions. Data was gathered through a one-time interview with mothers. Structural Equational Modeling (SEM) was applied for mediational mechanism testing. RESULTS: Among 13 ACE areas, most mothers experienced multiple adversity during their childhood (Mean (SD) = 4.93 (2.52)), with household member treated violently (75%) as the most common ACE. SEM results showedthat all domains of ACEs were associated with some aspects of maternal health, and all three domains of maternal health (maternal mental health, physical health, and adolescent pregnancy) were significantly associated with development of offspring's mental health problems. CONCLUSION: ACEs are highly prevalent in Kenyan informal settlements. Consistent with cross cultural literature on family stress model, maternal ACEs are robust predictors for poor child mental health. Preventive interventions for child mental health need to address maternal adverse childhood traumatic experiences as well as their current health in order to effectively promote child mental health.

Complementary Feeding: Beyond Nutrition.

In this article, we will summarize the key non-nutritional aspects of the introduction of complementary feeding. Intestinal maturation related to starch digestion is relatively complete by the time complementary feeding is recommended to be initiated. A much more complex maturation is needed, however, from the neurodevelopmental standpoint as the infants need to be able to hold their head and trunk and be able to coordinate tongue movement followed by swallowing. Issues can arise in infants with a history of medical problems as well as when caretakers cannot handle the initial difficulties or want to impose certain rigidity to the learning process. The introduction of complementary feedings is also part of the early steps in introduction to human socialization. In that regard, it sets up the infant to internalize and accept the diversity of food textures and food choices. Early refusal of some food items is common and should not be interpreted as being disliked. Multiple attempts should be made to incorporate new food items. To accomplish these dynamics, caregivers need comprehensive education and relevant information.

Correlates of isoniazid preventive therapy failure in child household contacts with infectious tuberculosis in high burden settings in Nairobi, Kenya - a cohort study.

BACKGROUND: Sub-Saharan Africa continues to document high pediatric tuberculosis (TB) burden, especially among the urban poor. One recommended preventive strategy involves tracking and isoniazid preventive therapy (IPT) for children under 5 years in close contact with infectious TB. However, sub-optimal effectiveness has been documented in diverse settings. We conducted a study to elucidate correlates to IPT strategy failure in children below 5 years in high burden settings. METHODS: A prospective longitudinal cohort study was done in informal settlings in Nairobi, where children under 5 years in household contact with recently diagnosed smear positive TB adults were enrolled. Consent was sought. Structured questionnaires administered sought information on index case treatment, socio-demographics and TB knowledge. Contacts underwent baseline clinical screening exclude TB and/or pre-existing chronic conditions. Contacts were then put on daily isoniazid for 6 months and monitored for new TB disease, compliance and side effects. Follow-up continued for another 6 months. RESULTS: At baseline, 428 contacts were screened, and 14(3.2%) had evidence of TB disease, hence excluded. Of 414 contacts put on IPT, 368 (88.8%) completed the 1 year follow-up. Operational challenges were reported by 258(70%) households, while 82(22%) reported side effects. Good compliance was documented in 89% (CI:80.2-96.2). By endpoint, 6(1.6%) contacts developed evidence of new TB disease and required definitive anti-tuberculosis therapy. The main factor associated with IPT failure was under-nutrition of contacts (p = 0.023). CONCLUSION: Under-nutrition was associated with IPT failure for child contacts below 5 years in high burden, resource limited settings. IPT effectiveness could be optimized through nutrition support of contacts.

What do we think we are doing? How might a clinical information network be promoting implementation of recommended paediatric care practices in Kenyan hospitals?

BACKGROUND: The creation of a clinical network was proposed as a means to promote implementation of a set of recommended clinical practices targeting inpatient paediatric care in Kenya. The rationale for selecting a network as a strategy has been previously described. Here, we aim to describe network activities actually conducted over its first 2.5 years, deconstruct its implementation into specific components and provide our 'insider' interpretation of how the network is functioning as an intervention. METHODS: We articulate key activities that together have constituted network processes over 2.5 years and then utilise a recently published typology of implementation components to give greater granularity to this description from the perspective of those delivering the intervention. Using the Behaviour Change Wheel we then suggest how the network may operate to achieve change and offer examples of change before making an effort to synthesise our understanding in the form of a realist context-mechanism-outcome configuration. RESULTS: We suggest our network is likely to comprise 22 from a total of 73 identifiable intervention components, of which 12 and 10 we consider major and minor components, respectively. At the policy level, we employed clinical guidelines, marketing and communication strategies with intervention characteristics operating through incentivisation, persuasion, education, enablement, modelling and environmental restructuring. These might influence behaviours by enhancing psychological capability, creating social opportunity and increasing motivation largely through a reflective pathway. CONCLUSIONS: We previously proposed a clinical network as a solution to challenges implementing recommended practices in Kenyan hospitals based on our understanding of theory and context. Here, we report how we have enacted what was proposed and use a recent typology to deconstruct the intervention into its elements and articulate how we think the network may produce change. We offer a more generalised statement of our theory of change in a context-mechanism-outcome configuration. We hope this will complement a planned independent evaluation of 'how things work', will help others interpret results of change reported more formally in the future and encourage others to consider further examination of networks as means to scale up improvement practices in health in lower income countries.

Building Learning Health Systems to Accelerate Research and Improve Outcomes of Clinical Care in Low- and Middle-Income Countries.

Mike English and colleagues argue that as efforts are made towards achieving universal health coverage it is also important to build capacity to develop regionally relevant evidence to improve healthcare.

Evaluation of a training DVD on pneumococcal conjugate vaccine for Kenyan EPI healthcare workers.

BACKGROUND: The Kenyan Ministry of Public Health and Sanitation was the first in Africa to introduce the new 10-valent Pneumococcal Conjugate Vaccine, PCV-10, in 2011. For successful implementation and to avoid adverse events following immunisation, specific training on handling and storage of the PCV-10 vaccine was required. Therefore, a training DVD was recorded in English and partly in Kiswahili to be used in combination with in-classroom training. Since the Kenyan Immunisation Programme was the first to use a DVD for training healthcare workers, an evaluation was done to obtain feedback on content, format and use, and propose suggestions to improve quality and uptake of the DVD. METHODS: Feedback was obtained from nurses and vaccinology course participants through the completion of a questionnaire. Nurses also participated in focus group discussions and trainers in key informant interviews. RESULTS: Twelve trainers, 72 nurses and 26 international vaccinology course participants provided feedback, with some notable differences between the three study groups. The survey results confirmed the acceptability of the content and format, and the feasibility of using the DVD in combination with in-classroom teaching. To improve the quality and adoption of the DVD, key suggestions were: Inclusion of all EPI vaccines and other important health issues; broad geographic distribution of the DVD; and bilingual English/Kiswahili use of languages or subtitles. DISCUSSION: The Kenyan DVD is appreciated by a heterogeneous and international audience rendering the DVD suitable for other Anglophone African countries. Differences between feedback from nurses and vaccinology course participants can be explained by the practical approach of the DVD and the higher education and service level of the latter. A drawback is the use of DVD players and televisions due to lack of electricity, but it is a matter of time before all rural health facilities in Africa will have access to electricity and modern technology.

Urine neutrophil gelatinase-associated lipocalin in asphyxiated neonates: a prospective cohort study.

BACKGROUND: Acute kidney injury (AKI) is the most common complication of perinatal asphyxia. Recent research indicates that urine neutrophil gelatinase-associated lipocalin (NGAL) is an early marker for AKI; yet, there is a paucity of data about its use in term neonates with perinatal asphyxia. METHODS: A prospective cohort study was conducted on 108 term babies in the new-born unit of Pumwani Maternity Hospital and Kenyatta National Hospital. Urine NGAL and serum creatinine were measured in 108 term asphyxiated neonates on days 1 and 3 of life. RESULTS: One-hundred and eight patients were recruited (male:female 1.4:1). At a cut-off of 250 ng/ml, urine NGAL had an acceptable discriminative capability of predicting AKI (area under the curve 0.724). The sensitivity, specificity, positive and negative predictive value and likelihood ratios were 88, 56, 30, 95%, 2 and 0.2 respectively. Urine NGAL levels were significantly higher in patients with AKI compared with those without AKI. An NGAL level greater than 250 ng/ml on day 1 was significantly associated with severe hypoxic ischaemic encephalopathy (HIE); odds ratio = 8.9 (95% CI 1.78-37.69) and mortality; odds ratio = 8.9 (95% CI 1.78-37.69). CONCLUSION: Urine NGAL is a good screening test for the early diagnosis of AKI. It is also a predictor of mortality and severity of HIE in asphyxiated neonates.

Delivery outcomes and patterns of morbidity and mortality for neonatal admissions in five Kenyan hospitals.

A cross-sectional survey was conducted in neonatal and maternity units of five Kenyan district public hospitals. Data for 1 year were obtained: 3999 maternal and 1836 neonatal records plus tallies of maternal deaths, deliveries and stillbirths. There were 40 maternal deaths [maternal mortality ratio: 276 per 100 000 live births, 95% confidence interval (CI): 197-376]. Fresh stillbirths ranged from 11 to 43 per 1000 births. A fifth (19%, 263 of 1384, 95% CI: 11-30%) of the admitted neonates died. Compared with normal birth weight, odds of death were significantly higher in all of the low birth weight (LBW, <2500 g) categories, with the highest odds for the extremely LBW (<1000 g) category (odds ratio: 59, 95% CI: 21-158, p < 0.01). The observed maternal mortality, stillbirths and neonatal mortality call for implementation of the continuum of care approach to intervention delivery with particular emphasis on LBW babies.

Medical device regulation and oversight in African countries: a scoping review of literature and development of a conceptual framework.

Regulatory and other governance arrangements influence the introduction of medical devices into health systems and are essential for ensuring their effective and safe use. Challenges with medical device safety, quality and use are documented globally, with evidence suggesting these are linked to poor governance. Yet, medical device regulation and oversight remain inadequately defined and described, particularly in low-income and middle-income settings. Through this review, we sought to examine the literature available on regulatory and oversight processes for medical devices in African countries.Following a systematic approach, we searched academic databases including PubMed, Embase (Ovid) and MEDLINE (Ovid), supplemented by search for grey literature and relevant organisational websites, for documents describing medical device regulation and oversight in African countries. We summarised the data to present key actors, areas for regulation and oversight and challenges.A total of 39 documents reporting regulation and oversight of medical devices were included for analysis. Regulatory and oversight guidelines and processes were reported as inadequate, including limited pre-market testing, reliance on international certifications and limited processes for post-market monitoring and reporting of adverse events. Challenges for regulation and oversight reported included inadequate funding, personnel and technical expertise to perform regulatory functions. The literature highlighted gaps in guidelines for donated medical devices and in information on governance processes at the national level.The current literature provides a general overview of medical device regulatory guidelines and limited evidence on the implementation of regulatory/oversight processes at national and especially subnational levels. We recommend further research to elucidate existing governance arrangements for medical devices within African countries and propose a conceptual framework to inform future studies. The framework provides entry points for careful examination of governance and oversight in policy and practice, the exploration of governance realities across the health system and the influence of wider system dynamics.

Institutionalizing the Management of Sick Young Infants: Kenya's Experience in Revising National Guidelines on Integrated Management of Newborn and Childhood Illnesses.

INTRODUCTION: In 2015, the World Health Organization (WHO) developed guidelines for the management of sick young infants (SYIs) with possible serious bacterial infection (PSBI) where referral is not feasible. The Ponya Mtoto project was designed as an implementation research project to demonstrate how to adopt the WHO PSBI guidelines in the Kenyan context. PONYA MTOTO PROJECT DESCRIPTION: Between October 2017 and June 2021, Ponya Mtoto was implemented in 4 Kenyan counties with higher infant and newborn mortality rates than the national mean. A total of 48 health facilities stratified by level of services were selected as study sites. IMPLEMENTATION APPROACH: The following activities were done to institutionalize the management of SYIs with PSBI where referral is not feasible in Kenya's health system: (1) participating in a cocreation workshop and development of a theory of change; (2) revising the national integrated management of newborn and childhood illnesses guidelines to incorporate the management of PSBI where referral is not feasible; (3) improving availability of essential commodities; (4) strengthening provider confidence in the management of SYIs; (5) strengthening awareness about PSBI services for SYIs at the community level; and (6) harmonizing the national integrated management of newborn and childhood illnesses guidelines to address discrepancies in the content on the management of PSBI. In addition, the project focused on strengthening quality of care for SYIs and using implementation research to track progress in achieving project targets and outcomes. CONCLUSION: Using an implementation research approach to introduce new WHO guidelines on PSBI where referral is not feasible into Kenya's health care service was critical to fostering engagement of a diverse range of stakeholders, monitoring provider skills and confidence-building, strengthening provision of key commodities for managing SYIs with PSBI, and sustaining community-facility linkages.

Characterising Kenyan hospitals' suitability for medical officer internship training: a secondary data analysis of a cross-sectional study.

OBJECTIVE: To characterise the capacity of Kenya internship hospitals to understand whether they are suitable to provide internship training for medical doctors. DESIGN: A secondary data analysis of a cross-sectional health facility assessment (Kenya Harmonized Health Facility Assessment (KHFA) 2018). SETTING AND POPULATION: We analysed 61 out of all 74 Kenyan hospitals that provide internship training for medical doctors. OUTCOME MEASURES: Comparing against the minimum requirement outlined in the national guidelines for medical officer interns, we filtered and identified 166 indicators from the KHFA survey questionnaire and grouped them into 12 domains. An overall capacity index was calculated as the mean of 12 domain-specific scores for each facility. RESULTS: The average overall capacity index is 69% (95% CI 66% to 72%) for all internship training centres. Hospitals have moderate capacity (over 60%) for most of the general domains, although there is huge variation between hospitals and only 29 out of 61 hospitals have five or more specialists assigned, employed, seconded or part-time-as required by the national guideline. Quality and safety score was low across all hospitals with an average score of 40%. As for major specialties, all hospitals have good capacity for surgery and obstetrics-gynaecology, while mental health was poorest in comparison. Level 5 and 6 facilities (provincial and national hospitals) have higher capacity scores in all domains when compared with level 4 hospitals (equivalent to district hospitals). CONCLUSION: Major gaps exist in staffing, equipment and service availability of Kenya internship hospitals. Level 4 hospitals (equivalent to district hospitals) are more likely to have a lower capacity index, leading to low quality of care, and should be reviewed and improved to provide appropriate and well-resourced training for interns and to use appropriate resources to avoid improvising.

Devolved health system capacity in the provision of care for sick newborns and young infants in four counties serving vulnerable populations in Kenya.

Possible severe bacterial infections (PSBI) is one of the three leading causes of newborn and young infant mortality globally that can be prevented by timely diagnosis and treatment using suitable antibiotics. High impact interventions such as use of out-patient injectable gentamicin and dispersible Amoxicillin with community-based follow up have been shown to reduce mortality in clinical trials. The objective of this study was to assess the health systems' preparedness and organizational gaps that may impact execution in providing care for newborns and sick young infants. This formative research study was embedded within a three-year implementation research project in 4 Counties in Kenya. The indicators were based on facility audits for existing capacity to care for newborns and young infants as well as County organizational capacity assessment. The organizational capacity assessment domains were derived from the World Health Organization's Health Systems Building blocks for health service delivery. The scores were computed by adding average scores in each domain and calculated against the total possible scores to generate a percentage outcome. Statistical analyses were descriptive with adjustment for clustering of data. Overall, the Counties have inadequate organizational capacity for management of sick young infants with Organizational Capacity Index scores of between 61-64%. Among the domains, the highest score was in Health Management Information System and service delivery. The lowest scores were in monitoring and evaluation (M&E). Counties scored relatively low scores in human resources for health and health products and commodities with one scoring poorly for both areas while the rest scored average performance. The four counties revealed varying levels of organizational capacity deficit to effectively manage sick young infants. The key underlying issues for the below par performance include poor coordination, low funding, inadequate supportive supervision, and M&E to enable data utilisation for quality improvement. It was evident that newborn and young infant health services suffer from inadequate infrastructure, equipment, staffing, and coordination. As Kenya, continuously rolls out the guidelines on management of sick young infants, there is need to focus attention to these challenges to enhance sustainable adoption and reduction of young infant morbidity and mortality.

WHO preferred product characteristics for monoclonal antibodies for passive immunization against respiratory syncytial virus (RSV) disease in infants - Key considerations for global use.

World Health Organization (WHO) preferred product characteristics describe preferences for product attributes that would help optimize value and use to address global public health needs, with a particular focus on low- and middle-income countries. Having previously published preferred product characteristics for both maternal and paediatric respiratory syncytial virus (RSV) vaccines, WHO recently published preferred product characteristics for monoclonal antibodies to prevent severe RSV disease in infants. This article summarizes the key attributes from the preferred product characteristics and discusses key considerations for future access and use of preventive RSV monoclonal antibodies.

A multifaceted intervention to implement guidelines and improve admission paediatric care in Kenyan district hospitals: a cluster randomised trial.

BACKGROUND: In developing countries referral of severely ill children from primary care to district hospitals is common, but hospital care is often of poor quality. However, strategies to change multiple paediatric care practices in rural hospitals have rarely been evaluated. METHODS AND FINDINGS: This cluster randomized trial was conducted in eight rural Kenyan district hospitals, four of which were randomly assigned to a full intervention aimed at improving quality of clinical care (evidence-based guidelines, training, job aides, local facilitation, supervision, and face-to-face feedback; n  =  4) and the remaining four to control intervention (guidelines, didactic training, job aides, and written feedback; n  =  4). Prespecified structure, process, and outcome indicators were measured at baseline and during three and five 6-monthly surveys in control and intervention hospitals, respectively. Primary outcomes were process of care measures, assessed at 18 months postbaseline. In both groups performance improved from baseline. Completion of admission assessment tasks was higher in intervention sites at 18 months (mean  =  0.94 versus 0.65, adjusted difference 0.54 [95% confidence interval 0.05-0.29]). Uptake of guideline recommended therapeutic practices was also higher within intervention hospitals: adoption of once daily gentamicin (89.2% versus 74.4%; 17.1% [8.04%-26.1%]); loading dose quinine (91.9% versus 66.7%, 26.3% [-3.66% to 56.3%]); and adequate prescriptions of intravenous fluids for severe dehydration (67.2% versus 40.6%; 29.9% [10.9%-48.9%]). The proportion of children receiving inappropriate doses of drugs in intervention hospitals was lower (quinine dose >40 mg/kg/day; 1.0% versus 7.5%; -6.5% [-12.9% to 0.20%]), and inadequate gentamicin dose (2.2% versus 9.0%; -6.8% [-11.9% to -1.6%]). CONCLUSIONS: Specific efforts are needed to improve hospital care in developing countries. A full, multifaceted intervention was associated with greater changes in practice spanning multiple, high mortality conditions in rural Kenyan hospitals than a partial intervention, providing one model for bridging the evidence to practice gap and improving admission care in similar settings.

Quality of hospital care for sick newborns and severely malnourished children in Kenya: a two-year descriptive study in 8 hospitals.

BACKGROUND: Given the high mortality associated with neonatal illnesses and severe malnutrition and the development of packages of interventions that provide similar challenges for service delivery mechanisms we set out to explore how well such services are provided in Kenya. METHODS: As a sub-component of a larger study we evaluated care during surveys conducted in 8 rural district hospitals using convenience samples of case records. After baseline hospitals received either a full multifaceted intervention (intervention hospitals) or a partial intervention (control hospitals) aimed largely at improving inpatient paediatric care for malaria, pneumonia and diarrhea/dehydration. Additional data were collected to: i) examine the availability of routine information at baseline and their value for morbidity, mortality and quality of care reporting, and ii) compare the care received against national guidelines disseminated to all hospitals. RESULTS: Clinical documentation for neonatal and malnutrition admissions was often very poor at baseline with case records often entirely missing. Introducing a standard newborn admission record (NAR) form was associated with an increase in median assessment (IQR) score to 25/28 (22-27) from 2/28 (1-4) at baseline. Inadequate and incorrect prescribing of penicillin and gentamicin were common at baseline. For newborns considerable improvements in prescribing in the post baseline period were seen for penicillin but potentially serious errors persisted when prescribing gentamicin, particularly to low-birth weight newborns in the first week of life. Prescribing essential feeds appeared almost universally inadequate at baseline and showed limited improvement after guideline dissemination. CONCLUSION: Routine records are inadequate to assess newborn care and thus for monitoring newborn survival interventions. Quality of documented inpatient care for neonates and severely malnourished children is poor with limited improvement after the dissemination of clinical practice guidelines. Further research evaluating approaches to improving care for these vulnerable groups is urgently needed. We also suggest pre-service training curricula should be better aligned to help improve newborn survival particularly.

How to do no harm: empowering local leaders to make care safer in low-resource settings.

In a companion paper, we showed how local hospital leaders could assess systems and identify key safety concerns and targets for system improvement. In the present paper, we consider how these leaders might implement practical, low-cost interventions to improve safety. Our focus is on making immediate safety improvements both to directly improve patient care and as a foundation for advancing care in the longer-term. We describe a 'portfolio' approach to safety improvement in four broad categories: prioritising critical processes, such as checking drug doses; strengthening the overall system of care, for example, by introducing multiprofessional handovers; control of known risks, such as only using continuous positive airway pressure when appropriate conditions are met; and enhancing detection and response to hazardous situations, such as introducing brief team meetings to identify and respond to immediate threats and challenges. Local clinical leaders and managers face numerous challenges in delivering safe care but, if given sufficient support, they are nevertheless in a position to bring about major improvements. Skills in improving safety and quality should be recognised as equivalent to any other form of (sub)specialty training and as an essential element of any senior clinical or management role. National professional organisations need to promote appropriate education and provide coaching, mentorship and support to local leaders.

Neonatal mortality in Kenyan hospitals: a multisite, retrospective, cohort study.

BACKGROUND: Most of the deaths among neonates in low-income and middle-income countries (LMICs) can be prevented through universal access to basic high-quality health services including essential facility-based inpatient care. However, poor routine data undermines data-informed efforts to monitor and promote improvements in the quality of newborn care across hospitals. METHODS: Continuously collected routine patients' data from structured paper record forms for all admissions to newborn units (NBUs) from 16 purposively selected Kenyan public hospitals that are part of a clinical information network were analysed together with data from all paediatric admissions ages 0-13 years from 14 of these hospitals. Data are used to show the proportion of all admissions and deaths in the neonatal age group and examine morbidity and mortality patterns, stratified by birth weight, and their variation across hospitals. FINDINGS: During the 354 hospital months study period, 90 222 patients were admitted to the 14 hospitals contributing NBU and general paediatric ward data. 46% of all the admissions were neonates (aged 0-28 days), but they accounted for 66% of the deaths in the age group 0-13 years. 41 657 inborn neonates were admitted in the NBUs across the 16 hospitals during the study period. 4266/41 657 died giving a crude mortality rate of 10.2% (95% CI 9.97% to 10.55%), with 60% of these deaths occurring on the first-day of admission. Intrapartum-related complications was the single most common diagnosis among the neonates with birth weight of 2000 g or more who died. A threefold variation in mortality across hospitals was observed for birth weight categories 1000-1499 g and 1500-1999 g. INTERPRETATION: The high proportion of neonatal deaths in hospitals may reflect changing patterns of childhood mortality. Majority of newborns died of preventable causes (>95%). Despite availability of high-impact low-cost interventions, hospitals have high and very variable mortality proportions after stratification by birth weight.