Search

Objective: To assess the availability of resources that support the provision of basic neonatal care in eight first-referral level (district) hospitals in Kenya.Methods: We selected two hospitals each from four of Kenya's eight provinces with the aim of representing the diversity of this part of the health system in Kenya. We created a checklist of 53 indicator items necessary for providing essential basic care to newborns and assessed their availability at each of the eight hospitals by direct observation, and then compared our observations with the opinions of health workers providing care to newborns on recent availability for some items, using a self-administered structured questionnaire.Results: The hospitals surveyed were often unable to maintain a safe hygienic environment for patients and health care workers; staffing was insufficient and sometimes poorly organised to support the provision of care; some key equipment, laboratory tests, drugs and consumables were not available while patient management guidelines were missing in all sites.Conclusion: Hospitals appear relatively poorly prepared to fill their proposed role in ensuring newborn survival. More effective interventions are needed to improve them to meet the special needs of this at-risk group. [ABSTRACT FROM AUTHOR]

Abstract Background We have reported the results of a cluster randomized trial of rural Kenyan hospitals evaluating the effects of an intervention to introduce care based on best-practice guidelines. In parallel work we described the context of the study, explored the process and perceptions of the intervention, and undertook a discrete study on health worker motivation because this was felt likely to be an important contributor to poor performance in Kenyan public sector hospitals. Here, we use data from these multiple studies and insights gained from being participants in and observers of the intervention process to provide our explanation of how intervention effects were achieved as part of an effort to better understand implementation in low-income hospital settings. Methods Initial hypotheses were generated to explain the variation in intervention effects across place, time, and effect measure (indicator) based on our understanding of theory and informed by our implementation experience and participant observations. All data sources available for hospitals considered as cases for study were then examined to determine if hypotheses were supported, rejected, or required modification. Data included transcriptions of interviews and group discussions, field notes and that from the detailed longitudinal quantitative investigation. Potentially useful explanatory themes were identified, discussed by the implementing and research team, revised, and merged as part of an iterative process aimed at building more generic explanatory theory. At the end of this process, findings were mapped against a recently reported comprehensive framework for implementation research. Results A normative re-educative intervention approach evolved that sought to reset norms and values concerning good practice and promote 'grass-roots' participation to improve delivery of correct care. Maximal effects were achieved when this strategy and external support supervision helped create a soft-contract with senior managers clarifying roles and expectations around desired performance. This, combined with the support of facilitators acting as an expert resource and 'shop-floor' change agent, led to improvements in leadership, accountability, and resource allocation that enhanced workers' commitment and capacity and improved clinical microsystems. Provision of correct care was then particularly likely if tasks were simple and a good fit to existing professional routines. Our findings were in broad agreement with those defined as part of recent work articulating a comprehensive framework for implementation research. Conclusions Using data from multiple studies can provide valuable insight into how an intervention is working and what factors may explain variability in effects. Findings clearly suggest that major intervention strategies aimed at improving child and newborn survival in low-income settings should go well beyond the fixed inputs (training, guidelines, and job aides) that are typical of many major programmes. Strategies required to deliver good care in low-income settings should recognize that this will need to be co-produced through engagement often over prolonged periods and as part of a directive but adaptive, participatory, information-rich, and reflective process.

Abstract 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.

Abstract Background There are few reports of interventions to reduce the common but irrational use of antibiotics for acute non-bloody diarrhoea amongst hospitalised children in low-income settings. We undertook a secondary analysis of data from an intervention comprising training of health workers, facilitation, supervision and face-to-face feedback, to assess whether it reduced inappropriate use of antibiotics in children with non-bloody diarrhoea and no co-morbidities requiring antibiotics, compared to a partial intervention comprising didactic training and written feedback only. This outcome was not a pre-specified end-point of the main trial. Methods Repeated cross-sectional survey data from a cluster-randomised controlled trial of an intervention to improve management of common childhood illnesses in Kenya were used to describe the prevalence of inappropriate antibiotic use in a 7-day period in children aged 2-59 months with acute non-bloody diarrhoea. Logistic regression models with random effects for hospital were then used to identify patient and clinician level factors associated with inappropriate antibiotic use and to assess the effect of the intervention. Results 9, 459 admission records of children were reviewed for this outcome. Of these, 4, 232 (44.7%) were diagnosed with diarrhoea, with 130 of these being bloody (dysentery) therefore requiring antibiotics. 1, 160 children had non-bloody diarrhoea and no co-morbidities requiring antibiotics-these were the focus of the analysis. 750 (64.7%) of them received antibiotics inappropriately, 313 of these being in the intervention hospitals vs. 437 in the controls. The adjusted logistic regression model showed the baseline-adjusted odds of inappropriate antibiotic prescription to children admitted to the intervention hospitals was 0.30 times that in the control hospitals (95%CI 0.09-1.02). Conclusion We found some evidence that the multi-faceted, sustained intervention described in this paper led to a reduction in the inappropriate use of antibiotics in treating children with non-bloody diarrhoea. Trial registration International Standard Randomised Controlled Trial Number Register ISRCTN42996612

Abstract Background It is increasingly appreciated that the interpretation of health systems research studies is greatly facilitated by detailed descriptions of study context and the process of intervention. We have undertaken an 18-month hospital-based intervention study in Kenya aiming to improve care for admitted children and newborn infants. Here we describe the baseline characteristics of the eight hospitals as environments receiving the intervention, as well as the general and local health system context and its evolution over the 18 months. Methods Hospital characteristics were assessed using previously developed tools assessing the broad structure, process, and outcome of health service provision for children and newborns. Major health system or policy developments over the period of the intervention at a national level were documented prospectively by monitoring government policy announcements, the media, and through informal contacts with policy makers. At the hospital level, a structured, open questionnaire was used in face-to-face meetings with senior hospital staff every six months to identify major local developments that might influence implementation. These data provide an essential background for those seeking to understand the generalisability of reports describing the intervention's effects, and whether the intervention plausibly resulted in these effects. Results Hospitals had only modest capacity, in terms of infrastructure, equipment, supplies, and human resources available to provide high-quality care at baseline. For example, hospitals were lacking between 30 to 56% of items considered necessary for the provision of care to the seriously ill child or newborn. An increase in spending on hospital renovations, attempts to introduce performance contracts for health workers, and post-election violence were recorded as examples of national level factors that might influence implementation success generally. Examples of factors that might influence success locally included frequent and sometimes numerous staff changes, movements of senior departmental or administrative staff, and the presence of local 'donor' partners with alternative priorities. Conclusion The effectiveness of interventions delivered at hospital level over periods realistically required to achieve change may be influenced by a wide variety of factors at national and local levels. We have demonstrated how dynamic such contexts are, and therefore the need to consider context when interpreting an intervention's effectiveness.

Abstract Background We have conducted an intervention study aiming to improve hospital care for children and newborns in Kenya. In judging whether an intervention achieves its aims, an understanding of how it is delivered is essential. Here, we describe how the implementation team delivered the intervention over 18 months and provide some insight into how health workers, the primary targets of the intervention, received it. Methods We used two approaches. First, a description of the intervention is based on an analysis of records of training, supervisory and feedback visits to hospitals, and brief logs of key topics discussed during telephone calls with local hospital facilitators. Record keeping was established at the start of the study for this purpose with analyses conducted at the end of the intervention period. Second, we planned a qualitative study nested within the intervention project and used in-depth interviews and small group discussions to explore health worker and facilitators' perceptions of implementation. After thematic analysis of all interview data, findings were presented, discussed, and revised with the help of hospital facilitators. Results Four hospitals received the full intervention including guidelines, training and two to three monthly support supervision and six monthly performance feedback visits. Supervisor visits, as well as providing an opportunity for interaction with administrators, health workers, and facilitators, were often used for impromptu, limited refresher training or orientation of new staff. The personal links that evolved with senior staff seemed to encourage local commitment to the aims of the intervention. Feedback seemed best provided as open meetings and discussions with administrators and staff. Supervision, although sometimes perceived as fault finding, helped local facilitators become the focal point of much activity including key roles in liaison, local monitoring and feedback, problem solving, and orientation of new staff to guidelines. In four control hospitals receiving a minimal intervention, local supervision and leadership to implement new guidelines, despite their official introduction, were largely absent. Conclusion The actual content of an intervention and how it is implemented and received may be critical determinants of whether it achieves its aims. We have carefully described our intervention approach to facilitate appraisal of the quantitative results of the intervention's effect on quality of care. Our findings suggest ongoing training, external supportive supervision, open feedback, and local facilitation may be valuable additions to more typical in-service training approaches, and may be feasible.

Background: Progress in neonatal care has resulted in a 51% decrease in global neonatal mortality rates from 1990 to 2017. Enhanced survival will put pressure on health care systems to provide appropriate post-discharge, follow-up care but the scale of need for such care is poorly defined., Methods: We conducted a retrospective cohort study of newborns discharged from 23 public hospital neonatal units (NBUs) in Kenya between January 2018 and June 2023 to identify initial follow-up needs. We first determined pragmatic follow-up categories based on survivors' clinical conditions and morbidities. We then used individual phenotypes of individual babies to assign them to needing one or more forms of specialized clinical follow-up. We use descriptive statistics to estimate proportions of those with specific needs and patterns of need., Findings: Among 136,249/159,792 (85.3%) neonates discharged, around one-third (33%) were low birth weight (<2,500 g), and a similar 33.4% were preterm (<37 weeks). We estimated 131,351 initial episodes of follow-up would be needed across nine distinct follow-up categories: general pediatrics, nutrition, growth & development (40.4%), auditory screening (38.8%), ophthalmology for retinopathy of prematurity (9.6%), neurology (8.0%), occupational therapy (1.3%), specialized nutrition (0.9%), surgery (0.8%), cardiology (0.2%), and pulmonary (<0.1%). Most neonates met the criteria for two (52.3%, 28,733), followed by three (39.6%, 21,738) and one follow-up episodes (5.6%, 3,098). In addition to prematurity and very low birth weight (≤1,500 g), severe infections with extended gentamicin treatment, severe jaundice managed with phototherapy, and hypoxic-ischemic encephalopathy (HIE) contributed substantially to the pattern of need for post-discharge follow-up., Conclusions: Almost half of surviving NBU infants have multiple specialty post-discharge follow-up needs. More urgent attention needs to be focused on healthcare planning now to guide strategies to address the varied medical and developmental needs that we outline in resource-constrained contexts like Kenya., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Wainaina, Lee, Irimu, Aluvaala, English and The Clinical Information Network Author Group.)

Background: The emergence of COVID-19 precipitated containment policies (e.g., lockdowns, school closures, etc.). These policies disrupted healthcare, potentially eroding gains for Sustainable Development Goals including for neonatal mortality. Our analysis aimed to evaluate indirect effects of COVID-19 containment policies on neonatal admissions and mortality in 67 neonatal units across Kenya, Malawi, Nigeria, and Tanzania between January 2019 and December 2021., Methods: The Oxford Stringency Index was applied to quantify COVID-19 policy stringency over time for Kenya, Malawi, Nigeria, and Tanzania. Stringency increased markedly between March and April 2020 for these four countries (although less so in Tanzania), therefore defining the point of interruption. We used March as the primary interruption month, with April for sensitivity analysis. Additional sensitivity analysis excluded data for March and April 2020, modelled the index as a continuous exposure, and examined models for each country. To evaluate changes in neonatal admissions and mortality based on this interruption period, a mixed effects segmented regression was applied. The unit of analysis was the neonatal unit (n = 67), with a total of 266,741 neonatal admissions (January 2019 to December 2021)., Results: Admission to neonatal units decreased by 15% overall from February to March 2020, with half of the 67 neonatal units showing a decline in admissions. Of the 34 neonatal units with a decline in admissions, 19 (28%) had a significant decrease of ≥ 20%. The month-to-month decrease in admissions was approximately 2% on average from March 2020 to December 2021. Despite the decline in admissions, we found no significant changes in overall inpatient neonatal mortality. The three sensitivity analyses provided consistent findings., Conclusion: COVID-19 containment measures had an impact on neonatal admissions, but no significant change in overall inpatient neonatal mortality was detected. Additional qualitative research in these facilities has explored possible reasons. Strengthening healthcare systems to endure unexpected events, such as pandemics, is critical in continuing progress towards achieving Sustainable Development Goals, including reducing neonatal deaths to less than 12 per 1000 live births by 2030., (© 2024. The Author(s).)

Background: Reports on hypothermia from high-burden countries like Kenya amongst sick newborns often include few centers or relatively small sample sizes., Objectives: This study endeavored to describe: (i) the burden of hypothermia on admission across 21 newborn units in Kenya, (ii) any trend in prevalence of hypothermia over time, (iii) factors associated with hypothermia at admission, and (iv) hypothermia's association with inpatient neonatal mortality., Methods: A retrospective cohort study was conducted from January 2020 to March 2023, focusing on small and sick newborns admitted in 21 NBUs. The primary and secondary outcome measures were the prevalence of hypothermia at admission and mortality during the index admission, respectively. An ordinal logistic regression model was used to estimate the relationship between selected factors and the outcomes cold stress (36.0°C-36.4°C) and hypothermia (<36.0°C). Factors associated with neonatal mortality, including hypothermia defined as body temperature below 36.0°C, were also explored using logistic regression., Results: A total of 58,804 newborns from newborn units in 21 study hospitals were included in the analysis. Out of these, 47,999 (82%) had their admission temperature recorded and 8,391 (17.5%) had hypothermia. Hypothermia prevalence decreased over the study period while admission temperature documentation increased. Significant associations were found between low birthweight and very low (0-3) APGAR scores with hypothermia at admission. Odds of hypothermia reduced as ambient temperature and month of participation in the Clinical Information Network (a collaborative learning health platform for healthcare improvement) increased. Hypothermia at admission was associated with 35% (OR 1.35, 95% CI 1.22, 1.50) increase in odds of neonatal inpatient death., Conclusions: A substantial proportion of newborns are admitted with hypothermia, indicating a breakdown in warm chain protocols after birth and intra-hospital transport that increases odds of mortality. Urgent implementation of rigorous warm chain protocols, particularly for low-birth-weight babies, is crucial to protect these vulnerable newborns from the detrimental effects of hypothermia., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The reviewer LD declared shared affiliation with one of the authors MO to the handling editor at the time of the review., (© 2024 Wainaina, Ogero, Mumelo, Wairoto, Mbevi, Tuti, Mwaniki, Irimu, English, Aluvaala and The Clinical Information Network Author Group.)

Background: Service readiness tools are important for assessing hospital capacity to provide quality small and sick newborn care (SSNC). Lack of summary scoring approaches for SSNC service readiness means we are unable to track national targets such as the Every Newborn Action Plan targets., Methods: A health facility assessment (HFA) tool was co-designed by Newborn Essential Solutions and Technologies (NEST360) and UNICEF with four African governments. Data were collected in 68 NEST360-implementing neonatal units in Kenya, Malawi, Nigeria, and Tanzania (September 2019-March 2021). Two summary scoring approaches were developed: a) standards-based, including items for SSNC service readiness by health system building block (HSBB), and scored on availability and functionality, and b) level-2 + , scoring items on readiness to provide WHO level-2 + clinical interventions. For each scoring approach, scores were aggregated and summarised as a percentage and equally weighted to obtain an overall score by hospital, HSBB, and clinical intervention., Results: Of 1508 HFA items, 1043 (69%) were included in standards-based and 309 (20%) in level-2 + scoring. Sixty-eight neonatal units across four countries had median standards-based scores of 51% [IQR 48-57%] at baseline, with variation by country: 62% [IQR 59-66%] in Kenya, 49% [IQR 46-51%] in Malawi, 50% [IQR 42-58%] in Nigeria, and 55% [IQR 53-62%] in Tanzania. The lowest scoring was family-centred care [27%, IQR 18-40%] with governance highest scoring [76%, IQR 71-82%]. For level-2 + scores, the overall median score was 41% [IQR 35-51%] with variation by country: 50% [IQR 44-53%] in Kenya, 41% [IQR 35-50%] in Malawi, 33% [IQR 27-37%] in Nigeria, and 41% [IQR 32-52%] in Tanzania. Readiness to provide antibiotics by culture report was the highest-scoring intervention [58%, IQR 50-75%] and neonatal encephalopathy management was the lowest-scoring [21%, IQR 8-42%]. In both methods, overall scores were low (< 50%) for 27 neonatal units in standards-based scoring and 48 neonatal units in level-2 + scoring. No neonatal unit achieved high scores of > 75%., Discussion: Two scoring approaches reveal gaps in SSNC readiness with no neonatal units achieving high scores (> 75%). Government-led quality improvement teams can use these summary scores to identify areas for health systems change. Future analyses could determine which items are most directly linked with quality SSNC and newborn outcomes., (© 2024. The Author(s).)

Background: Each year an estimated 2.3 million newborns die in the first 28 days of life. Most of these deaths are preventable, and high-quality neonatal care is fundamental for surviving and thriving. Service readiness is used to assess the capacity of hospitals to provide care, but current health facility assessment (HFA) tools do not fully evaluate inpatient small and sick newborn care (SSNC)., Methods: Health systems ingredients for SSNC were identified from international guidelines, notably World Health Organization (WHO), and other standards for SSNC. Existing global and national service readiness tools were identified and mapped against this ingredients list. A novel HFA tool was co-designed according to a priori considerations determined by policymakers from four African governments, including that the HFA be completed in one day and assess readiness across the health system. The tool was reviewed by > 150 global experts, and refined and operationalised in 64 hospitals in Kenya, Malawi, Nigeria, and Tanzania between September 2019 and March 2021., Results: Eight hundred and sixty-six key health systems ingredients for service readiness for inpatient SSNC were identified and mapped against four global and eight national tools measuring SSNC service readiness. Tools revealed major content gaps particularly for devices and consumables, care guidelines, and facility infrastructure, with a mean of 13.2% (n = 866, range 2.2-34.4%) of ingredients included. Two tools covered 32.7% and 34.4% (n = 866) of ingredients and were used as inputs for the new HFA tool, which included ten modules organised by adapted WHO health system building blocks, including: infrastructure, pharmacy and laboratory, medical devices and supplies, biomedical technician workshop, human resources, information systems, leadership and governance, family-centred care, and infection prevention and control. This HFA tool can be conducted at a hospital by seven assessors in one day and has been used in 64 hospitals in Kenya, Malawi, Nigeria, and Tanzania., Conclusion: This HFA tool is available open-access to adapt for use to comprehensively measure service readiness for level-2 SSNC, including respiratory support. The resulting facility-level data enable comparable tracking for Every Newborn Action Plan coverage target four within and between countries, identifying facility and national-level health systems gaps for action., (© 2024. The Author(s).)

Background: One in five newborns in Nairobi County, Kenya, may require inpatient neonatal care. We sought to examine referrals to and from three busy first-level referral public hospitals in Nairobi and what infrastructure and systems are available to support neonatal transport from these first-referral level hospitals to the main tertiary care center., Methods: Patient-level data of newborns over 12 months were retrospectively extracted from routinely collected patient data and examined to characterize those referred into and out of three newborn units in the study hospitals. Structural assessments using a checklist completed during hospital visits were used to describe hospitals' readiness to support newborn referral and transport., Results: Five percent (398/7720) of the cohort studied were either referrals into study hospitals (68%, 272/398) or referrals out (32%, 126/398). Among 397 (99%) and 268 (67%) with sex and gestation documented respectively, 63% (251) were male and 44% (118) were preterm infants (<37 weeks). Among those referred in, 26% (69/272) died and 2.6% (7/272) were further referred to a tertiary-care newborn unit. Prematurity (39%) and birth asphyxia (29%) were the main in-referral reasons from 38 different health facilities, with specialist reviews (34%) predominant for out-referrals to a tertiary center. Diverse transport methods were used for referrals to study hospitals including private and public ambulances, vehicles, and guardian's arms while onward referrals to the tertiary center were done by hospital ambulances. Drugs and medical supplies required for stabilization were well available at the study sites, however, only oxygen nasal cannula, nasal prongs, and face masks were available in ambulance of hospital 3., Conclusion: There is a need to develop, equip and maintain a high-quality referral and newborn transport system that can support the continuum of newborn care across referral care pathways into and from first-referral level hospitals., Competing Interests: No competing interests were disclosed., (Copyright: © 2023 Wainaina J et al.)

Background: Medical devices are critical to providing high-quality, hospital-based newborn care, yet many of these devices are unavailable in low- and middle-income countries (LMIC) and are not designed to be suitable for these settings. Target Product Profiles (TPPs) are often utilised at an early stage in the medical device development process to enable user-defined performance characteristics for a given setting. TPPs can also be applied to assess the profile and match of existing devices for a given context., Methods: We developed initial TPPs for 15 newborn product categories for LMIC settings. A Delphi-like process was used to develop the TPPs. Respondents completed an online survey where they scored their level of agreement with each of the proposed performance characteristics for each of the 15 devices. Characteristics with < 75% agreement between respondents were discussed and voted on using Mentimeter™ at an in-person consensus meeting., Findings: The TPP online survey was sent to 180 people, of which 103 responded (57%). The majority of respondents were implementers/clinicians (51%, 53/103), with 50% (52/103) from LMIC. Across the 15 TPPs, 403 (60%) of the 668 performance characteristics did not achieve > 75% agreement. Areas of disagreement were voted on by 69 participants at an in-person consensus meeting, with consensus achieved for 648 (97%) performance characteristics. Only 20 (3%) performance characteristics did not achieve consensus, most (15/20) relating to quality management systems. UNICEF published the 15 TPPs in April 2020, accompanied by a report detailing the online survey results and consensus meeting discussion, which has been viewed 7,039 times (as of January 2023)., Conclusions: These 15 TPPs can inform developers and enable implementers to select neonatal care products for LMIC. Over 2,400 medical devices and diagnostics meeting these TPPs have been installed in 65 hospitals in Nigeria, Tanzania, Kenya, and Malawi through the NEST360 Alliance. Twenty-three medical devices identified and qualified by NEST360 meet nearly all performance characteristics across 11 of the 15 TPPs. Eight of the 23 qualified medical devices are available in the UNICEF Supply Catalogue. Some developers have adjusted their technologies to meet these TPPs. There is potential to adapt the TPP process beyond newborn care., (© 2023. The Author(s).)

Background: Every Newborn Action Plan (ENAP) coverage target 4 necessitates national scale-up of Level-2 Small and Sick Newborn Care (SSNC) (with Continuous Positive Airway Pressure (CPAP)) in 80% of districts by 2025. Routine neonatal inpatient data is important for improving quality of care, targeting equity gaps, and enabling data-driven decision-making at individual, district, and national-levels. Existing neonatal inpatient datasets vary in purpose, size, definitions, and collection processes. We describe the co-design and operationalisation of a core inpatient dataset for use to track outcomes and improve quality of care for small and sick newborns in high-mortality settings., Methods: A three-step systematic framework was used to review, co-design, and operationalise this novel neonatal inpatient dataset in four countries (Malawi, Kenya, Tanzania, and Nigeria) implementing with the Newborn Essential Solutions and Technologies (NEST360) Alliance. Existing global and national datasets were identified, and variables were mapped according to categories. A priori considerations for variable inclusion were determined by clinicians and policymakers from the four African governments by facilitated group discussions. These included prioritising clinical care and newborn outcomes data, a parsimonious variable list, and electronic data entry. The tool was designed and refined by > 40 implementers and policymakers during a multi-stakeholder workshop and online interactions., Results: Identified national and international datasets (n = 6) contained a median of 89 (IQR:61-154) variables, with many relating to research-specific initiatives. Maternal antenatal/intrapartum history was the largest variable category (21, 23.3%). The Neonatal Inpatient Dataset (NID) includes 60 core variables organised in six categories: (1) birth details/maternal history; (2) admission details/identifiers; (3) clinical complications/observations; (4) interventions/investigations; (5) discharge outcomes; and (6) diagnosis/cause-of-death. Categories were informed through the mapping process. The NID has been implemented at 69 neonatal units in four African countries and links to a facility-level quality improvement (QI) dashboard used in real-time by facility staff., Conclusion: The NEST360 NID is a novel, parsimonious tool for use in routine information systems to inform inpatient SSNC quality. Available on the NEST360/United Nations Children's Fund (UNICEF) Implementation Toolkit for SSNC, this adaptable tool enables facility and country-level comparisons to accelerate progress toward ENAP targets. Additional linked modules could include neonatal at-risk follow-up, retinopathy of prematurity, and Level-3 intensive care., (© 2023. The Author(s).)

Background: Apnoea of prematurity (AOP) is a common condition among preterm infants. Methylxanthines, such as caffeine and aminophylline/theophylline, can help prevent and treat AOP. Due to its physiological benefits and fewer side effects, caffeine citrate is recommended for the prevention and treatment of AOP. However, caffeine citrate is not available in most resource-constrained settings (RCS) due to its high cost. Challenges in RCS using caffeine citrate to prevent AOP include identifying eligible preterm infants where gestational age is not always known and the capability for continuous monitoring of vital signs to readily identify apnoea. We aim to develop an evidence-based care bundle that includes caffeine citrate to prevent and manage AOP in tertiary healthcare facilities in Kenya., Methods: This protocol details a prospective mixed-methods clinical feasibility study on using caffeine citrate to manage apnoea of prematurity in a single facility tertiary-care newborn unit (NBU) in Nairobi, Kenya. This study will include a 4-month formative research phase followed by the development of an AOP clinical-care-bundle prototype over 2 months. In the subsequent 4 months, implementation and improvement of the clinical-care-bundle prototype will be undertaken. The baseline data will provide contextualised insights on care practices within the NBU that will inform the development of a context-sensitive AOP clinical-care-bundle prototype. The clinical care bundle will be tested and refined further during an implementation phase of the quality improvement initiative using a PDSA framework underpinned by quantitative and qualitative clinical audits and stakeholders' engagement. The quantitative component will include all neonates born at gestation age < 34 weeks and any neonate prescribed aminophylline or caffeine citrate admitted to the NBU during the study period., Discussion: There is a need to develop evidence-based and context-sensitive clinical practice guidelines to standardise and improve the management of AOP in RCS. Concerns requiring resolution in implementing such guidelines include diagnosis of apnoea, optimal timing, dosing and administration of caffeine citrate, standardisation of monitoring devices and alarm limits, and discharge protocols. We aim to provide a feasible standardised clinical care bundle for managing AOP in low and middle-income settings., (© 2023. The Author(s).)

Poor-quality paediatric and neonatal care in district hospitals in low-income and middle-income countries (LMICs) was first highlighted more than 20 years ago. WHO recently developed more than 1000 paediatric and neonatal quality indicators for hospitals. Prioritising these indicators should account for the challenges in producing reliable process and outcome data in these settings, and their measurement should not unduly narrow the focus of global and national actors to reports of measured indicators. A three-tier, long-term strategy for the improvement of paedicatric and neonatal care in LMIC district hospitals is needed, comprising quality measurement, governance, and front-line support. Measurement should be better supported by integrating data from routine information systems to reduce the future cost of surveys. Governance and quality management processes need to address system-wide issues and develop supportive institutional norms and organisational culture. This strategy requires governments, regulators, professions, training institutions, and others to engage beyond the initial consultation on indicator selection, and to tackle the pervasive constraints that undermine the quality of district hospital care. Institutional development must be combined with direct support to hospitals. Too often the focus of indicator measurement as an improvement strategy is on reporting up to regional or national managers, but not on providing support down to hospitals to attain quality care., Competing Interests: Declaration of interests The authors all receive funding for research linked to the improvement of hospital care in low-income and middle-income countries. ME, TD, JA, and GI have or have had roles as technical advisers to WHO in the fields of newborn and child health. MM declares no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Primary care is of insufficient quality in many low-income and middle-income countries. Some health facilities perform better than others despite operating in similar contexts, although the factors that characterise best performance are not well known. Existing best-performance analyses are concentrated in high-income countries and focus on hospitals. We used the positive deviance approach to identify the factors that differentiate best from worst primary care performance among health facilities across six low-resource health systems., Methods: This positive deviance analysis used nationally representative samples of public and private health facilities from Service Provision Assessments of the Democratic Republic of the Congo, Haiti, Malawi, Nepal, Senegal, and Tanzania. Data were collected starting June 11, 2013, in Malawi and ending Feb 28, 2020, in Senegal. We assessed facility performance through completion of the Good Medical Practice Index (GMPI) of essential clinical actions (eg, taking a thorough history, conducting an adequate physical examination) according to clinical guidelines and measured with direct observations of care. We identified hospitals and clinics in the top decile of performance (defined as best performers) and conducted a quantitative, cross-national positive deviance analysis to compare them with facilities performing below the median (defined as worst performers) and identify facility-level factors that explain the gap between best and worst performance., Findings: We identified 132 best-performing and 664 worst-performing hospitals, and 355 best-performing and 1778 worst-performing clinics based on clinical performance across countries. The mean GMPI score was 0·81 (SD 0·07) for the best-performing hospitals and 0·44 (0·09) for the worst-performing hospitals. Among clinics, mean GMPI scores were 0·75 (0·07) for the best performers and 0·34 (0·10) for the worst performers. High-quality governance, management, and community engagement were associated with best performance compared with worst performance. Private facilities out-performed government-owned hospitals and clinics., Interpretation: Our findings suggest that best-performing health facilities are characterised by good management and leaders who can engage staff and community members. Governments should look to best performers to identify scalable practices and conditions for success that can improve primary care quality overall and decrease quality gaps between health facilities., Funding: Bill & Melinda Gates Foundation., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Introduction: There is growing evidence that parental participation in the care of small and sick newborns benefits both babies and parents. While studies have investigated the roles that mothers play in newborn units in high income contexts (HIC), there is little exploration of how contextual factors interplay to influence the ways in which mothers participate in the care of their small and sick newborn babies in very resource constrained settings such as those found in many countries in sub-Saharan Africa., Methods: Ethnographic methods (observations, informal conversations and formal interviews) were used to collect data during 627 h of fieldwork between March 2017 and August 2018 in the neonatal units of one government and one faith-based hospital in Kenya. Data were analysed using a modified grounded theory approach., Results: There were marked differences between the hospitals in the participation by mothers in the care of their sick newborn babies. The timing and types of caring task that the mothers undertook were shaped by the structural, economic and social context of the hospitals. In the resource constrained government funded hospital, the immediate informal and unplanned delegation of care to mothers was routine. In the faith-based hospital mothers were initially separated from their babies and introduced to bathing and diaper change tasks slowly under the close supervision of nurses. In both hospitals appropriate breast-feeding support was lacking, and the needs of the mothers were largely ignored., Conclusion: In highly resource constrained hospitals with low nurse to baby ratios, mothers are required to provide primary and some specialised care to their sick newborns with little information or support on how undertake the necessary tasks. In better resourced hospital settings, most caring tasks are initially performed by nurses leaving mothers feeling powerless and worried about their capacity to care for their babies after discharge. Interventions need to focus on how to better equip hospitals and nurses to support mothers in caring for their sick newborns, promoting family centred care., (© 2023. The Author(s).)

Clinical audits are an important intervention that enables health workers to reflect on their practice and identify and act on modifiable gaps in the care provided. To effectively audit the quality of care provided to the small and sick newborns, the clinical audit process must use a structured tool that comprehensively covers the continuum of newborn care from immediately after birth to the period of newborn unit care. The objective of the study was to co-design a newborn clinical audit tool that considered the key principles of a Human Centred Design approach. A three-step Human Centred Design approach was used that began by (1) understanding the context, the users and the available audit tools through literature, focus group discussions and a consensus meeting that was used to develop a prototype audit tool and its implementation guide, (2) the prototype audit tool was taken through several cycles of reviewing with users on real cases in a high volume newborn unit and refining it based on their feedback, and (3) the final prototype tool and the implementation guide were then tested in two high volume newborn units to determine their usability. Several cycles of evaluation and redesigning of the prototype audit tool revealed that the users preferred a comprehensive tool that catered to human factors such as reduced free text for ease of filling, length of the tool, and aesthetics. Identified facilitators and barriers influencing the newborn clinical audit in Kenyan public hospitals informed the design of an implementation guide that builds on the strengths and overcomes the barriers. We adopted a Human Centred Design approach to developing a newborn clinical audit tool and an implementation guide that we believe are comprehensive and consider the characteristics of the context of use and the user requirements., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Ogola et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: The high burden of respiratory syncytial virus (RSV) infection in young children disproportionately occurs in low- and middle-income countries (LMICs). The PROUD (Preventing RespiratOry syncytial virUs in unDerdeveloped countries) Taskforce of 24 RSV worldwide experts assessed key needs for RSV prevention in LMICs, including vaccine and newer preventive measures., Methods: A global, survey-based study was undertaken in 2021. An online questionnaire was developed following three meetings of the Taskforce panellists wherein factors related to RSV infection, its prevention and management were identified using iterative questioning. Each factor was scored, by non-panellists interested in RSV, on a scale of zero (very-low-relevance) to 100 (very-high-relevance) within two scenarios: (1) Current and (2) Future expectations for RSV management., Results: Ninety questionnaires were completed: 70 by respondents (71.4% physicians; 27.1% researchers/scientists) from 16 LMICs and 20 from nine high-income (HI) countries (90.0% physicians; 5.0% researchers/scientists), as a reference group. Within LMICs, RSV awareness was perceived to be low, and management was not prioritised. Of the 100 factors scored, those related to improved diagnosis particularly access to affordable point-of-care diagnostics, disease burden data generation, clinical and general education, prompt access to new interventions, and engagement with policymakers/payers were identified of paramount importance. There was a strong need for clinical education and local data generation in the lowest economies, whereas upper-middle income countries were more closely aligned with HI countries in terms of current RSV service provision., Conclusion: Seven key actions for improving RSV prevention and management in LMICs are proposed., Competing Interests: The reviewer PAP declared a past co-authorship with the author(s) FMT to the handling. XCE and BP have received research funding and/or compensation as advisor/lecturer from AbbVie and AstraZeneca. JF and BRG, working for Violicom and former company, have previously received payment from AbbVie and AstraZeneca for work on various projects. MCN reports grants from the Bill & Melinda Gates Foundation, European & Developing Countries Clinical Trials Partnership, Pfizer, AstraZeneca and Sanofi-Pasteur; and personal fees from Pfizer and Sanofi-Pasteur. RTS has received fees for Advisory Board meetings and lectures for Sanofi-Pasteur, AstraZeneca, Janssen, and AbbVie. QB serves in the Independent Data Monitoring Committee (IDMC) for Respiratory Syncytial Virus (RSV) vaccine development for the protection of infants (since October 2015) (GlaxoSmithKline -GSK). JP reports grants to his institution from MedImmune, Merck, Sanofi Pasteur and AbbVie, and personal fees from AbbVie, Merck and AstraZeneca. JMP reports grants to his institution from MedImmune. HJZ has received funding for RSV-related research studies from Pfizer, AstraZeneca, Merck and the Bill & Melinda Gates Foundation. AM has received research funding from Merck and Janssen and compensation as advisor/lecturer from Sanofi-Pasteur and AstraZeneca. IM has been an investigator on studies funded by MedImmune, Regeneron, and Boehringer. MAS has received research funding from Janssen and compensation as advisor/lecturer from AbbVie, Sanofi-Pasteur and AstraZeneca. All declarations made by authors outside of the submitted work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2022 Carbonell-Estrany, Simões, Bont, Gentile, Homaira, Scotta, Stein, Torres, Sheikh, Broor, Khuri-Bulos, Nokes, Munywoki, Bassat, Sharma, Basnet, Garba, De Jesus-Cornejo, Lupisan, Nunes, Divarathna, Fullarton, Rodgers-Gray, Keary, Reñosa, Verwey, Moore, Noordeen, Kabra, do Vale, Paternina-De La Ossa, Mariño, Figueras-Aloy, Krilov, Berezin, Zar, Paudel, Safadi, Dbaibo, Jroundi, Jha, Rafeek, Pinheiro, Bracht, Muthugala, Lanari, Martinón-Torres, Mitchell, Irimu, Pandey, Krishnan, Mejias, Santos Corrêa Da Costa, Shrestha, Pernica, Cotrim de Carvalho, Jalango, Ibrahim, Ewa, Ensinck, Ulloa-Gutierrez, Miralha, Lucion, Hassan, Akhtar, Aleem, Chowdhury, Rojo, Sande, Musau, Zaman, Arlant, Ghimire, Price, Subedi, Brenes-Chacon, Goswami, Rahman, Hossain, Chisti, Vain, Lim, Chiu, Papenburg, Juarez, Senaratne, Arunasalam, Strand, Ayuk, Ogunrinde, Tavares, Garba, Garba, Dawa, Gordon, Osoro, Agoti, Nyawanda, Ngama, Tabu, Mathew, Cornacchia, Rai, Jain, Giongo and Paes.)

The objectives of this study were to (1)explore the quality of clinical data generated from hospitals providing in-patient neonatal care participating in a clinical information network (CIN) and whether data improved over time, and if data are adequate, (2)characterise accuracy of prescribing for basic treatments provided to neonatal in-patients over time. This was a retrospective cohort study involving neonates ≤28 days admitted between January 2018 and December 2021 in 20 government hospitals with an interquartile range of annual neonatal inpatient admissions between 550 and 1640 in Kenya. These hospitals participated in routine audit and feedback processes on quality of documentation and care over the study period. The study's outcomes were the number of patients as a proportion of all eligible patients over time with (1)complete domain-specific documentation scores, and (2)accurate domain-specific treatment prescription scores at admission, reported as incidence rate ratios. 80,060 neonatal admissions were eligible for inclusion. Upon joining CIN, documentation scores in the monitoring, other physical examination and bedside testing, discharge information, and maternal history domains demonstrated a statistically significant month-to-month relative improvement in number of patients with complete documentation of 7.6%, 2.9%, 2.4%, and 2.0% respectively. There was also statistically significant month-to-month improvement in prescribing accuracy after joining the CIN of 2.8% and 1.4% for feeds and fluids but not for Antibiotic prescriptions. Findings suggest that much of the variation observed is due to hospital-level factors. It is possible to introduce tools that capture important clinical data at least 80% of the time in routine African hospital settings but analyses of such data will need to account for missingness using appropriate statistical techniques. These data allow exploration of trends in performance and could support better impact evaluation, exploration of links between health system inputs and outcomes and scrutiny of variation in quality and outcomes of hospital care., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Tuti et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Attention has turned to improving the quality and safety of healthcare within health facilities to reduce avoidable mortality and morbidity. Interventions should be tested in health system environments that can support their adoption if successful. To be successful, interventions often require changes in multiple behaviours making their consequences unpredictable. Here, we focus on this challenge of change at the mesolevel or microlevel. Drawing on multiple insights from theory and our own empirical work, we highlight the importance of engaging managers, senior and frontline staff and potentially patients to explore foundational questions examining three core resource areas. These span the physical or material resources available, workforce capacity and capability and team and organisational relationships. Deficits in all these resource areas may need to be addressed to achieve success. We also argue that as inertia is built into the complex social and human systems characterising healthcare facilities that thought on how to mobilise five motive forces is needed to help achieve change. These span goal alignment and ownership, leadership for change, empowering key actors, promoting responsive planning and procurement and learning for transformation. Our aim is to bridge the theory-practice gap and offer an entry point for practical discussions to elicit the critical tacit and contextual knowledge needed to design interventions. We hope that this may improve the chances that interventions are successful and so contribute to better facility-based care and outcomes while contributing to the development of learning health systems., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Competing Interests: YbN is an employee of WHO. The views and opinions expressed in this Comment do not necessarily express the policies of WHO. All other authors declare no competing interests.

Background: Medication errors are likely common in low- and middle-income countries (LMICs). In neonatal hospital care where the population with severe illness has a high mortality rate, around 14.9% of drug prescriptions have errors in LMICs settings. However, there is scant research on interventions to improve medication safety to mitigate such errors. Our objective is to improve routine neonatal care particularly focusing on effective prescribing practices with the aim of achieving reduced gentamicin medication errors., Methods: We propose to conduct an audit and feedback (A&F) study over 12 months in 20 hospitals with 12 months of baseline data. The medical and nursing leaders on their newborn units had been organised into a network that facilitates evaluating intervention approaches for improving quality of neonatal care in these hospitals and are receiving basic feedback generated from the baseline data. In this study, the network will (1) be expanded to include all hospital pharmacists, (2) include a pharmacist-only professional WhatsApp discussion group for discussing prescription practices, and (3) support all hospitals to facilitate pharmacist-led continuous medical education seminars on prescription practices at hospital level, i.e. default intervention package. A subset of these hospitals (n = 10) will additionally (1) have an additional hospital-specific WhatsApp group for the pharmacists to discuss local performance with their local clinical team, (2) receive detailed A&F prescription error reports delivered through mobile-based dashboard, and (3) receive a PDF infographic summarising prescribing performance circulated to the clinicians through the hospital-specific WhatsApp group, i.e. an extended package. Using interrupted time series analysis modelling changes in prescribing errors over time, coupled with process fidelity evaluation, and WhatsApp sentiment analysis, we will evaluate the success with which the A&F interventions are delivered, received, and acted upon to reduce prescribing error while exploring the extended package's success/failure relative to the default intervention package., Discussion: If effective, these theory-informed A&F strategies that carefully consider the challenges of LMICs settings will support the improvement of medication prescribing practices with the insights gained adapted for other clinical behavioural targets of a similar nature., Trial Registration: PACTR, PACTR202203869312307 . Registered 17th March 2022., (© 2022. The Author(s).)

Despite health gains over the past 30 years, children and adolescents are not reaching their health potential in many low-income and middle-income countries (LMICs). In addition to health systems, social systems, such as schools, communities, families, and digital platforms, can be used to promote health. We did a targeted literature review of how well health and social systems are meeting the needs of children in LMICs using the framework of The Lancet Global Health Commission on high-quality health systems and we reviewed evidence for structural reforms in health and social sectors. We found that quality of services for children is substandard across both health and social systems. Health systems have deficits in care competence (eg, diagnosis and management), system competence (eg, timeliness, continuity, and referral), user experience (eg, respect and usability), service provision for common and serious conditions (eg, cancer, trauma, and mental health), and service offerings for adolescents. Education and social services for child health are limited by low funding and poor coordination with other sectors. Structural reforms are more likely to improve service quality substantially and at scale than are micro-level efforts. Promising approaches include governing for quality (eg, leadership, expert management, and learning systems), redesigning service delivery to maximise outcomes, and empowering families to better care for children and to demand quality care from health and social systems. Additional research is needed on health needs across the life course, health system performance for children and families, and large-scale evaluation of promising health and social programmes., Competing Interests: Declaration of interests ZAB reports grants from International Development Research Centre, UNICEF, WHO, The Rockefeller Foundation, and the Institute of International Education, during the conduct of the study. TZ reports grants from International Development Research Centre, UNICEF, WHO, The Rockefeller Foundation, and the Institute of International Education, during the conduct of the study. All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: Expression and storage of breastmilk is a strategy that ensures continued breast milk consumption in the event of temporary separation of an infant from the mother. However, many studies show that working mothers are unable to exclusively breastfeed for six months successfully. Working mothers are forced to wean early because of minimal support at the workplace, lack of knowledge on breast milk expression and lack of storage facilities. The 2017 Kenya Health Act mandates employers to provide lactation rooms for facilitation of breast milk expression in support of the lactating mother. This study analyses the knowledge attitude and practice of breast milk expression among working women in Kenya., Methods: This was a cross sectional study done between December 2018 and February 2019. Study participants were 395 working women with infants aged six months and below, attending well baby clinics in two large public hospitals in Nairobi Kenya. A structured questionnaire with open and closed ended questions was used to establish the knowledge and practice while a Likert scale was used to explore attitudes of the mothers towards expression and storage of breast milk., Results: Overall satisfactory knowledge on breast milk expression and storage was attained by only 34% of working mothers. Eighty four percent positively agreed that expression and storage of breast milk would help them achieve six months of exclusive breastfeeding. Challenges experienced were breast pain and cumbersome nature of expressing milk. Only 41% (161) were expressing breast milk either regularly or occasionally. The most common reason (24.7%) for expressing milk was to enable someone else feed the baby when they were at work. Most mothers (77%) expressed at home as the workplace did not seem to provide adequate equipment to facilitate breastmilk expression and storage., Conclusions: There is a substantial knowledge gap on expression and storage of breast milk. Working mothers have a good attitude towards attainment of exclusive breast milk feeding through expression of breast milk. The workplace does not have adequate facilities to support expression and storage of breast milk., (© 2022. The Author(s).)

Background: Audit of facility-based care provided to small and sick newborns is a quality improvement initiative that helps to identify the modifiable gaps in newborn care (BMC Pregnancy Childbirth 14: 280, 2014). The aim of this work was to identify literature on modifiable factors in the care of newborns in the newborn units in health facilities in low-middle-income countries (LMICs). We also set out to design a measure of the quality of the perinatal and newborn audit process., Methods: The scoping review was conducted using the methodology outlined by Arksey and O'Malley and refined by Levac et al, (Implement Sci 5:1-9, 2010). We reported our results using the PRISMA Extension for Scoping Reviews (PRISMA-ScR) guidelines. We identified seven factors to ensure a successful audit process based on World Health Organisation (WHO) recommendations which we subsequently used to develop a quality of audit process score., Data Sources: We conducted a structured search using PubMed, CINAHL, EMBASE, LILACS, POPLINE and African Index Medicus., Study Selection: Studies published in English between 1965 and December 2019 focusing on the identification of modifiable factors through clinical or mortality audits in newborn care in health facilities from LMICs., Data Extraction: We extracted data on the study characteristics, modifiable factors and quality of audit process indicators., Results: A total of six articles met the inclusion criteria. Of these, four were mortality audit studies and two were clinical audit studies that we used to assess the quality of the audit process. None of the studies were well conducted, two were moderately well conducted, and four were poorly conducted. The modifiable factors were divided into three time periods along the continuum of newborn care. The period of newborn unit care had the highest number of modifiable factors, and in each period, the health worker related modifiable factors were the most dominant., Conclusion: Based on the significant number of modifiable factors in the newborn unit, a neonatal audit tool is essential to act as a structured guide for auditing newborn unit care in LMICs. The quality of audit process guide is a useful method of ensuring high quality audits in health facilities., (© 2022. The Author(s).)

Background: Health care-associated infections (HCAI) in neonatal units in low- and middle-income countries (LMIC) are a major cause of mortality. This scoping review aimed to synthesise published literature on infection prevention and care bundles addressing neonatal HCAI in LMICs and to construct a Classification Framework for their components (elements)., Methods: Five electronic databases were searched between January 2001 and July 2020. A mixed-methods approach was applied: qualitative content analysis was used to build a classification framework to categorise bundle elements and the contents of the classification groups were then described quantitatively., Findings: 3619 records were screened, with 44 eligible studies identified. The bundle element Classification Framework created involved: (1) Primary prevention, (2) Detection , (3) Case management , and Implementation (3 + I ) . The 44 studies included 56 care bundles with 295 elements that were then classified. Primary prevention elements (128, 43%) predominated of which 71 (55%) focused on central line catheters and mechanical ventilators. Only 12 elements (4%) were related to detection . A further 75 (25%) elements addressed case management and 66 (88%) of these aimed at outbreak control., Interpretation: The 3 + I Classification Framework was a feasible approach to reporting and synthesising research for infection-relevant bundled interventions in neonatal units. A shift towards the use in infection prevention and care bundles of primary prevention elements focused on the neonate and on commonly used hospital devices in LMIC (e.g., self-inflating bags, suctioning equipment) would be valuable to reduce HCAI transmission. Detection elements were a major gap., Funding: This work was made possible in part by the John D. and Catherine T. MacArthur Foundation, the Bill & Melinda Gates Foundation, ELMA Philanthropies, The Children's Investment Fund Foundation UK, The Lemelson Foundation, and the Ting Tsung and Wei Fong Chao Foundation under agreements to William Marsh Rice University. The project leading to these results has also received the support of a fellowship from the "la Caixa" Foundation (ID 100010434). The fellowship code is LCF/BQ/EU19/11710040. EJAF is an Academic Clinical Fellow whose salary is funded by the UK National Institute for Health Research (NIHR). NES receives a Research Training Program Scholarship (Australian Commonwealth Government)., Competing Interests: We declare no competing interests., (© 2021 The Authors.)

Objectives: To characterise adoption and explore specific clinical and patient factors that might influence pulse oximetry and oxygen use in low-income and middle-income countries (LMICs) over time; to highlight useful considerations for entities working on programmes to improve access to pulse oximetry and oxygen., Design: A multihospital retrospective cohort study., Settings: All admissions (n=132 737) to paediatric wards of 18 purposely selected public hospitals in Kenya that joined a Clinical Information Network (CIN) between March 2014 and December 2020., Outcomes: Pulse oximetry use and oxygen prescription on admission; we performed growth-curve modelling to investigate the association of patient factors with study outcomes over time while adjusting for hospital factors., Results: Overall, pulse oximetry was used in 48.8% (64 722/132 737) of all admission cases. Use rose on average with each month of participation in the CIN (OR: 1.11, 95% CI 1.05 to 1.18) but patterns of adoption were highly variable across hospitals suggesting important factors at hospital level influence use of pulse oximetry. Of those with pulse oximetry measurement, 7% (4510/64 722) had hypoxaemia (SpO 2 <90%). Across the same period, 8.6% (11 428/132 737) had oxygen prescribed but in 87%, pulse oximetry was either not done or the hypoxaemia threshold (SpO 2 <90%) was not met. Lower chest-wall indrawing and other respiratory symptoms were associated with pulse oximetry use at admission and were also associated with oxygen prescription in the absence of pulse oximetry or hypoxaemia., Conclusion: The adoption of pulse oximetry recommended in international guidelines for assessing children with severe illness has been slow and erratic, reflecting system and organisational weaknesses. Most oxygen orders at admission seem driven by clinical and situational factors other than the presence of hypoxaemia. Programmes aiming to implement pulse oximetry and oxygen systems will likely need a long-term vision to promote adoption, guideline development and adherence and continuously examine impact., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: In resource-limited settings, acute respiratory infections continue to be the leading cause of death in young children. We conducted postmortem investigations in children <5 years hospitalized with a clinical diagnosis of respiratory disease at Kenya's largest referral hospital., Methods: We collected respiratory and other tissues postmortem to examine pathologic processes using histology, molecular and immunohistochemistry assays. Nasopharyngeal, trachea, bronchi and lung specimens were tested using 21-target respiratory pathogen real-time reverse transcription polymerase chain reaction assays deployed on Taqman Array Cards. Expert panels reviewed all findings to determine causes of death and associated pathogens., Results: From 2014 to 2015, we investigated 64 pediatric deaths (median age 7 months). Pneumonia was determined as cause of death in 70% (42/52) of cases where death was associated with an infectious disease process. The main etiologies of pneumonia deaths were respiratory syncytial virus (RSV) (n = 7, 19%), Pneumocystis jirovecii (n = 7, 19%), influenza A (n = 5, 14%) and Streptococcus pneumoniae (n = 5, 14%)-10% of cases had multi-pathogen involvement. Among the other 10 deaths associated with a nonpneumonia infectious process, 4 did not have an etiology assigned, the others were associated with miliary tuberculosis (2), cerebral thrombosis due to HIV (1), Enterobacteriaceae (1), rotavirus (1), and 1 case of respiratory infection with severe hypokalemia associated with RSV., Conclusions: In spite of well-established vaccination programs in Kenya, some deaths were still vaccine preventable. Accelerated development of RSV monoclonal antibodies and vaccines, introduction of seasonal influenza vaccination, and maintenance or improved uptake of existing vaccines can contribute to further reductions in childhood mortality., Competing Interests: Since completion of this work, S.S.C. has joined Sanofi Pasteur, France and M.-A.W. has joined the Institute of Tropical Medicine in Antwerp, Belgium. The other authors have no conflicts of interest to disclose., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Healthcare systems across the world and especially those in low-resource settings (LRS) are under pressure and one of the first priorities must be to prevent any harm done while trying to deliver care. Health care workers, especially department leaders, need the diagnostic abilities to identify local safety concerns and design actions that benefit their patients. We draw on concepts from the safety sciences that are less well-known than mainstream quality improvement techniques in LRS. We use these to illustrate how to analyse the complex interactions between resources and tools, the organisation of tasks and the norms that may govern behaviours, together with the strengths and vulnerabilities of systems. All interact to influence care and outcomes. To employ these techniques leaders will need to focus on the best attainable standards of care, build trust and shift away from the blame culture that undermines improvement. Health worker education should include development of the technical and relational skills needed to perform these system diagnostic roles. Some safety challenges need leadership from professional associations to provide important resources, peer support and mentorship to sustain safety work., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: COVID-19 is disrupting health services for mothers and newborns, particularly in low- and middle-income countries (LMIC). Preterm newborns are particularly vulnerable. We undertook analyses of the benefits of kangaroo mother care (KMC) on survival among neonates weighing ≤2000 g compared with the risk of SARS-CoV-2 acquired from infected mothers/caregivers., Methods: We modelled two scenarios over 12 months. Scenario 1 compared the survival benefits of KMC with universal coverage (99%) and mortality risk due to COVID-19. Scenario 2 estimated incremental deaths from reduced coverage and complete disruption of KMC. Projections were based on the most recent data for 127 LMICs (~90% of global births), with results aggregated into five regions., Findings: Our worst-case scenario (100% transmission) could result in 1,950 neonatal deaths from COVID-19. Conversely, 125,680 neonatal lives could be saved with universal KMC coverage. Hence, the benefit of KMC is 65-fold higher than the mortality risk of COVID-19. If recent evidence of 10% transmission was applied, the ratio would be 630-fold. We estimated a 50% reduction in KMC coverage could result in 12,570 incremental deaths and full disruption could result in 25,140 incremental deaths, representing a 2·3-4·6% increase in neonatal mortality across the 127 countries., Interpretation: The survival benefit of KMC far outweighs the small risk of death due to COVID-19. Preterm newborns are at risk, especially in LMICs where the consequences of disruptions are substantial. Policymakers and healthcare professionals need to protect services and ensure clearer messaging to keep mothers and newborns together, even if the mother is SARS-CoV-2-positive., Funding: Eunice Kennedy Shriver National Institute of Child Health & Human Development; Bill & Melinda Gates Foundation; Elma Philanthropies; Wellcome Trust; and Joint Global Health Trials scheme of Department of Health and Social Care, Department for International Development, Medical Research Council, and Wellcome Trust., Competing Interests: We declare no competing interests., (© 2021 The Authors.)

We have worked to develop a Clinical Information Network (CIN) in Kenya as an early form of learning health systems (LHS) focused on paediatric and neonatal care that now spans 22 hospitals. CIN's aim was to examine important outcomes of hospitalisation at scale, identify and ultimately solve practical problems of service delivery, drive improvements in quality and test interventions. By including multiple routine settings in research, we aimed to promote generalisability of findings and demonstrate potential efficiencies derived from LHS. We illustrate the nature and range of research CIN has supported over the past 7 years as a form of LHS. Clinically, this has largely focused on common, serious paediatric illnesses such as pneumonia, malaria and diarrhoea with dehydration with recent extensions to neonatal illnesses. CIN also enables examination of the quality of care, for example that provided to children with severe malnutrition and the challenges encountered in routine settings in adopting simple technologies (pulse oximetry) and more advanced diagnostics (eg, Xpert MTB/RIF). Although regular feedback to hospitals has been associated with some improvements in quality data continue to highlight system challenges that undermine provision of basic, quality care (eg, poor access to blood glucose testing and routine microbiology). These challenges include those associated with increased mortality risk (eg, delays in blood transfusion). Using the same data the CIN platform has enabled conduct of randomised trials and supports malaria vaccine and most recently COVID-19 surveillance. Employing LHS principles has meant engaging front-line workers, clinical managers and national stakeholders throughout. Our experience suggests LHS can be developed in low and middle-income countries that efficiently enable contextually appropriate research and contribute to strengthening of health services and research systems., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

In low and middle-income countries (LMIC) general hospitals are important for delivering some key acute care services. Neonatal care is emblematic of these acute services as averting deaths requires skilled care over many days from multiple professionals with at least basic equipment. However, hospital care is often of poor quality and large-scale change is needed to improve outcomes. In this manuscript we aim to show how we have drawn upon our understanding of contexts of care in Kenyan general hospital NBUs, and on social and behavioural theories that offer potential mechanisms of change in these settings, to develop an initial programme theory guiding a large scale change intervention to improve neonatal care and outcomes.  Our programme theory is an expression of our assumptions about what actions will be both useful and feasible.  It incorporates a recognition of our strengths and limitations as a research-practitioner partnership to influence change. The steps we employ represent the initial programme theory development phase commonly undertaken in many Realist Evaluations. However, unlike many Realist Evaluations that develop initial programme theories focused on pre-existing interventions or programmes, our programme theory informs the design of a new intervention that we plan to execute. Within this paper we articulate briefly how we propose to operationalise this new intervention. Finally, we outline the quantitative and qualitative research activities that we will use to address specific questions related to the delivery and effects of this new intervention, discussing some of the challenges of such study designs. We intend that this research on the intervention will inform future efforts to revise the programme theory and yield transferable learning., Competing Interests: Competing interests: All authors are supported by research funding for work in fields related to the topic of this manuscript, have been involved in early phases of developing the Kenyan Clinical Information Network or are members of organisations referred to in this report such as the Kenya Paediatric Association and the Kenya research team undertaking ongoing work on neonatal care., (Copyright: © 2020 English M et al.)

Background: The malaria prevalence has declined in western Kenya, resulting in the risk of neurological phenotypes in older children. This study investigates the clinical profile of pediatric malaria admissions ahead of the introduction of the RTS,S/AS01 vaccine., Methods: Malaria admissions in children aged 1 month to 15 years were identified from routine, standardized, inpatient clinical surveillance data collected between 2015 and 2018 from 4 hospitals in western Kenya. Malaria phenotypes were defined based on available data., Results: There were 5766 malaria admissions documented. The median age was 36 months (interquartile range, 18-60): 15% were aged between 1-11 months of age, 33% were aged 1-23 months of age, and 70% were aged 1 month to 5 years. At admission, 2340 (40.6%) children had severe malaria: 421/2208 (19.1%) had impaired consciousness, 665/2240 (29.7%) had an inability to drink or breastfeed, 317/2340 (13.6%) had experienced 2 or more convulsions, 1057/2340 (45.2%) had severe anemia, and 441/2239 (19.7%) had severe respiratory distress. Overall, 211 (3.7%) children admitted with malaria died; 163/211 (77% deaths, case fatality rate 7.0%) and 48/211 (23% deaths, case fatality rate 1.4%) met the criteria for severe malaria and nonsevere malaria at admission, respectively. The median age for fatal cases was 33 months (interquartile range, 12-72) and the case fatality rate was highest in those unconscious (44.4%)., Conclusions: Severe malaria in western Kenya is still predominantly seen among the younger pediatric age group and current interventions targeted for those <5 years are appropriate. However, there are increasing numbers of children older than 5 years admitted with malaria, and ongoing hospital surveillance would identify when interventions should target older children., (© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America.)