Meningococcal ACWYX Conjugate Vaccine in 2-to-29-Year-Olds in Mali and Gambia.

BACKGROUND: An effective, affordable, multivalent meningococcal conjugate vaccine is needed to prevent epidemic meningitis in the African meningitis belt. Data on the safety and immunogenicity of NmCV-5, a pentavalent vaccine targeting the A, C, W, Y, and X serogroups, have been limited. METHODS: We conducted a phase 3, noninferiority trial involving healthy 2-to-29-year-olds in Mali and Gambia. Participants were randomly assigned in a 2:1 ratio to receive a single intramuscular dose of NmCV-5 or the quadrivalent vaccine MenACWY-D. Immunogenicity was assessed at day 28. The noninferiority of NmCV-5 to MenACWY-D was assessed on the basis of the difference in the percentage of participants with a seroresponse (defined as prespecified changes in titer; margin, lower limit of the 96% confidence interval [CI] above -10 percentage points) or geometric mean titer (GMT) ratios (margin, lower limit of the 98.98% CI >0.5). Serogroup X responses in the NmCV-5 group were compared with the lowest response among the MenACWY-D serogroups. Safety was also assessed. RESULTS: A total of 1800 participants received NmCV-5 or MenACWY-D. In the NmCV-5 group, the percentage of participants with a seroresponse ranged from 70.5% (95% CI, 67.8 to 73.2) for serogroup A to 98.5% (95% CI, 97.6 to 99.2) for serogroup W; the percentage with a serogroup X response was 97.2% (95% CI, 96.0 to 98.1). The overall difference between the two vaccines in seroresponse for the four shared serogroups ranged from 1.2 percentage points (96% CI, -0.3 to 3.1) for serogroup W to 20.5 percentage points (96% CI, 15.4 to 25.6) for serogroup A. The overall GMT ratios for the four shared serogroups ranged from 1.7 (98.98% CI, 1.5 to 1.9) for serogroup A to 2.8 (98.98% CI, 2.3 to 3.5) for serogroup C. The serogroup X component of the NmCV-5 vaccine generated seroresponses and GMTs that met the prespecified noninferiority criteria. The incidence of systemic adverse events was similar in the two groups (11.1% in the NmCV-5 group and 9.2% in the MenACWY-D group). CONCLUSIONS: For all four serotypes in common with the MenACWY-D vaccine, the NmCV-5 vaccine elicited immune responses that were noninferior to those elicited by the MenACWY-D vaccine. NmCV-5 also elicited immune responses to serogroup X. No safety concerns were evident. (Funded by the U.K. Foreign, Commonwealth, and Development Office and others; ClinicalTrials.gov number, NCT03964012.).

Hypothermia in preterm infants admitted to low-resource neonatal units in northern Nigeria: an observational study of occurrence and risk factors.

BACKGROUND: Hypothermia is an important cause of morbidity and mortality among preterm and low-birth-weight neonates. In resource-constrained settings, limited referral infrastructure and technologies for temperature control potentiate preterm hypothermia. While there is some documentation on point-of-admission hypothermia from single center studies, there are limited multicenter studies on the occurrence of hypothermia among preterm infants in resource-limited-settings. Therefore, we conducted a multicenter study to determine the prevalence and risk factors for hypothermia at the time of admission and during the first 72 h after admission in northern Nigeria. METHOD: We carried out a prospective cohort study on preterm infants admitted to four referral hospitals in northern Nigerian between August 2020 and July 2021. We documented temperature measurements at admission and the lowest and highest temperatures in the first 72 h after admission. We also collected individual baby-level data on sociodemographic and perinatal history data. We used the World Health Organization classification of hypothermia to classify the babies' temperatures into mild, moderate, and severe hypothermia. Poisson regression analysis was used to identify risk factors for moderate-severe hypothermia. RESULTS: Of the 933 preterm infants enrolled, 682 (72.9%) had hypothermia at admission although the prevalence of hypothermia varied across the four hospitals. During the first 24 h after admission, 7 out of every 10 babies developed hypothermia. By 72 h after admission, between 10 and 40% of preterm infants across the 4 hospitals had at least one episode of moderate hypothermia. Gestational age (OR = 0.86; CI = 0.82-0.91), birth weight (OR = 8.11; CI = 2.87-22.91), presence of a skilled birth attendant at delivery (OR = 0.53; CI = 0.29-0.95), place of delivery (OR = 1.94 CI = 1.13-3.33) and resuscitation at birth (OR = 1.79; CI = 1.27-2.53) were significant risk factors associated with hypothermia. CONCLUSION: The prevalence of admission hypothermia in preterm infants is high and hypothermia is associated with low-birth-weight, place of delivery and presence of skilled birth attendant. The prevalence of hypothermia while in care is also high and this has important implications for patient safety and quality of patient care. Referral services for preterm infants need to be developed while hospitals need to be better equipped to maintain the temperatures of admitted small and sick newborns.

Missed nursing care in acute care hospital settings in low-income and middle-income countries: a systematic review.

BACKGROUND: Missed nursing care undermines nursing standards of care and minimising this phenomenon is crucial to maintaining adequate patient safety and the quality of patient care. The concept is a neglected aspect of human resource for health thinking, and it remains understudied in low-income and middle-income country (LMIC) settings which have 90% of the global nursing workforce shortages. Our objective in this review was to document the prevalence of missed nursing care in LMIC, identify the categories of nursing care that are most missed and summarise the reasons for this. METHODS: We conducted a systematic review searching Medline, Embase, Global Health, WHO Global index medicus and CINAHL from their inception up until August 2021. Publications were included if they were conducted in an LMIC and reported on any combination of categories, reasons and factors associated with missed nursing care within in-patient settings. We assessed the quality of studies using the Newcastle Ottawa Scale. RESULTS: Thirty-one studies met our inclusion criteria. These studies were mainly cross-sectional, from upper middle-income settings and mostly relied on nurses' self-report of missed nursing care. The measurement tools used, and their reporting were inconsistent across the literature. Nursing care most frequently missed were non-clinical nursing activities including those of comfort and communication. Inadequate personnel numbers were the most important reasons given for missed care. CONCLUSIONS: Missed nursing care is reported for all key nursing task areas threatening care quality and safety. Data suggest nurses prioritise technical activities with more non-clinical activities missed, this undermines holistic nursing care. Improving staffing levels seems a key intervention potentially including sharing of less skilled activities. More research on missed nursing care and interventions to tackle it to improve quality and safety is needed in LMIC. PROSPERO registration number: CRD42021286897.

Characterising support and care assistants in formal hospital settings: a scoping review.

BACKGROUND: A 15 million health workforce shortage is still experienced globally leading to a sub-optimal healthcare worker-to-population ratio in most countries. The use of low-skilled care assistants has been suggested as a cost-saving human resource for health strategy that can significantly reduce the risks of rationed, delayed, or missed care. However, the characterisation, role assignment, regulation, and clinical governance mechanisms for unlicensed assistive workforce remain unclear or inconsistent. The purpose of this study was to map and collate evidence of how care assistants are labelled, utilised, regulated, and managed in formal hospital settings as well as their impact on patient care. METHODS: We conducted a scoping review of literature from PUBMED, CINAHL, PsychINFO, EMBASE, Web of Science, Scopus, and Google Scholar. Searches and eligibility screening were conducted using the Participants-Context-Concepts framework. Thematic content analysis guided the synthesis of the findings. RESULTS: 73 records from a total of 15 countries were included in the final full-text review and synthesis. A majority (78%) of these sources were from high-income countries. Many titles are used to describe care assistants, and these vary within and across countries. On ascribed roles, care assistants perform direct patient care, housekeeping, clerical and documentation, portering, patient flow management, ordering of laboratory tests, emergency response and first aid duties. Additional extended roles that require higher competency levels exist in the United States, Australia, and Canada. There is a mixture of both positive and negative sentiments on their impact on patient care or nurses' perception and experiences. Clinical and organisational governance mechanisms vary substantially across the 15 countries. Licensure, regulatory mechanisms, and task-shifting policies are largely absent or not reported in these countries. CONCLUSIONS: The nomenclature used to describe care assistants and the tasks they perform vary substantially within countries and across healthcare systems. There is, therefore, a need to review and update the international and national classification of occupations for clarity and more meaningful nomenclature for care assistants. In addition, the association between care assistants and care outcomes or nurses' experience remains unclear. Furthermore, there is a dearth of empirical evidence on this topic from low- and middle-income countries.

Evaluating the effects of supplementing ward nurses on quality of newborn care in Kenyan neonatal units: protocol for a prospective workforce intervention study.

BACKGROUND: Data from High Income Countries have now linked low nurse staff to patient ratios to poor quality patient care. Adequately staffing hospitals is however still a challenge in resource-constrained Low-middle income countries (LMICs) and poor staff-to-patient ratios are largely taken as a norm. This in part relates to limited evidence on the relationship between staffing and quality of patient care in these settings and also an absence of research on benefits that might occur from improving hospital staff numbers in LMICs. This study will determine the effect on the quality of patient care of prospectively adding extra nursing staff to newborn units in a resource constrained LMIC setting and describe the relationship between staffing and quality of care. METHODS: This prospective workforce intervention study will involve a multi-method approach. We will conduct a before and after study in newborn units of 4 intervention hospitals and a single time-point comparison in 4 non-intervention hospitals to determine if there is a change in the level of missed nursing care, a process measure of the quality of patient care. We will also determine the effect of our intervention on routinely collected quality indicators using interrupted time series analysis. Using three nurse staffing metrics (Total nursing hours, nursing hours per patient day and nursing hours per patient per shift), we will describe the relationship between staffing and the quality of patient care. DISCUSSION: There is an urgent need for the implementation of staffing policies in resource constrained LMICs that are guided by relevant contextual data. To the best of our knowledge, this is the first study to evaluate the prospective addition of nursing staff in resource-constrained care settings. Our findings are likely to provide the much-needed evidence for better staffing in these settings. TRIAL REGISTRATION: This study was retrospectively registered in the Pan African Clinical Trial Registry ( https://pactr.samrc.ac.za/Default.aspx?Logout=True ) database on the 10th of June 2022 with a unique identification number-PACTR202206477083141.

Common mental disorders in mothers of children attending out-patient malnutrition clinics in rural North-western Nigeria: a cross-sectional study.

BACKGROUND: Children with uncomplicated severe acute malnutrition are managed routinely within out-patient malnutrition treatment programs. These programs do not offer maternal mental health support services, despite maternal mental health playing a significant role in the nutritional status of children. Additionally, the burden of maternal Common Mental Disorders (CMDs) is poorly described among mothers of children attending these programs. This study thus determined the burden and risk factors for maternal CMDs among children attending out-patient malnutrition clinics in rural North-western Nigeria. METHODS: We conducted a cross-sectional study among 204 mothers of children with severe acute malnutrition who attending eight out-patient malnutrition clinics in Jigawa, North-western Nigeria. We used the World Health Organization Self-Reporting Questionnaire-20 (WHO SRQ-20) screening tool, a recognised and validated proxy measure for CMDs to identify mothers with CMDs. The prevalence of maternal CMDs was determined by identifying the proportion of mothers with SRQ scores of ≥8. Risk factors for CMD were determined using multivariable logistic regression. RESULTS: Maternal CMD prevalence in children attending these facilities was high at 40.7%. Non-receipt of oral polio vaccine (OPV) (AOR 6.23, 95%CI 1.85 to 20.92) increased the odds for CMD. While spousal age above 40 (AOR 0.95, 95%CI 0.90 to 0.99) and long years spent married (AOR 0.92, 95%CI 0.85 to 0.98) decreased the odds for CMD. CONCLUSIONS: Our findings indicate maternal CMD burden is high in out-patient malnutrition clinics in North-western Nigeria. Maternal mental health services would need to be integrated into the community management of acute malnutrition programs to provide more holistic care, and possibly improve long-term outcomes after discharge from these programs.

A pre-COVID-19 assessment of aspects of the school health programme in some selected Nigerian primary schools: implications for school re-opening during the COVID-19 pandemic in developing country contexts.

BACKGROUND: Following the COVID-19 pandemic, school closures were part of the global public health response to limit community spread of the virus. In recent times, there has been an emphasis on safe school re-opening. This concept is likely to differ between developed and developing country settings. There are however no published studies on barriers hindering safe school re-opening within developing country contexts. This study evaluates aspects of the school health program (SHP) in some selected Nigerian schools that might relate to the pandemic control during school re-opening. METHODS: In 2017, we conducted a cross-sectional survey of the SHP of 146 registered primary schools in Gwagwalada Area Council in Abuja, Nigeria. These schools provided services to about 54,562 students. We used direct observational methods and interviewer-administered questionnaires to assess the SHP of each school. We compare SHP characteristics that might relate to COVID-19 control in schools across government-owned (public) and privately-owned (private) schools using a pre-defined framework. RESULTS: Public school to pupil ratios was more than six times that of private schools. Only 6.9% of all surveyed schools employed qualified health personnel. Although 8 in every 10 schools conducted health talks for communicable disease control, the use of temporary isolation and school-based immunization were low at 1.4 and 2.7% respectively. Pipe-borne water access was present in 4 of 10 schools, with public schools having more limited access than private schools (p = 0.009). Similarly, less proportion of public schools had access to soap for handwashing (p < 0.001). Adequate classroom ventilation was present in 63% of surveyed schools, with private schools having more limited ventilation (p < 0.001). CONCLUSIONS: Overcrowding and infrastructural deficits within developing country contexts represent barriers to safe school re-opening during the COVID-19 pandemic. In these settings, there needs to be tailored and innovative strategies which consider local practical realities when designing the COVID-19 control programs during school re-opening.

Facility-Based Newborn Deaths at a Referral Tertiary Hospital in North-Central Nigeria during the Sustainable Development Goal Era: A Retrospective Cohort Analysis.

BACKGROUND: Nigeria has the largest number of global under-five deaths and almost half of these occur in the newborn period in an almost 50:50 ratio across hospital facilities and communities. We examine and describe risk factors for newborn mortality at a busy neonatal unit of a referral tertiary hospital in North-central Nigeria. METHODS: We conducted a retrospective cohort analysis of all newborn admissions to the Dalhatu Araf Specialist Hospital between September 2018 and March 2020. We determined the newborn mortality rate (NMR) and case fatality rates (CFRs) for individual diagnostic categories and determined risk predictors for mortality using cox-proportional hazard models. RESULTS: Of 1171 admitted newborn infants, 175 (14.9%) died with about half of these occurring within 24 h of admission. Extremely low birth weight infants and those with congenital anomalies had the highest CFRs. Identified risk factors for mortality were age at admission [adjusted hazard ratio (AHR): 0.996, 95% CI: 0.993-0.999], admitting weight (AHR: 0.9995, 95% CI: 0.9993-0.9997) and home delivery (AHR: 1.65, 95% CI: 1.11-to 2.46). CONCLUSIONS: Facility-based newborn mortality is high in North-central Nigeria. Majority of these deaths occur within the first 24 h of admission, signifying challenges in acute critical newborn care. To improve the current situation and urgently accelerate progress to meet the sustainable development goal NMR targets, there is an urgent need to develop human and material resources for acute critical newborn care while encouraging facility-based delivery and decentralizing existing newborn care. Lay summaryNigeria now has the greatest number of deaths in children below the age of five globally. Almost half of these occurred in the newborn period and these deaths occur within hospital facilities and also in communities in an almost 50:50 ratio. As such, the country might not attain global newborn mortality rates that were set as targets for the sustainable development goals (SDGs). In this article, we examine and describe the risk factors for newborn deaths occurring at a typical newborn unit in North-central Nigeria. During the period under review, we found that about 175 (14.9%) died and about half of these deaths occurred within 24 h of admission. Extremely small babies and those who were born with physical defects had the highest death rates. Older babies and those who weighed more at admission had decreased risks of dying while being delivered at home increased the risk of death. Hospital newborn deaths remain high in North-central Nigeria and the pattern of early admission deaths signifies challenges in stabilizing critically ill newborn infants. There is an urgent need to develop human and material resources for acute critical newborn care while encouraging institutional delivery and decentralizing of existing newborn care.

Socio-demographic and Household-Level Risk Factors for Severe Acute Malnutrition in Pre-school Children in North-Western Nigeria.

BACKGROUND: Severe acute malnutrition (SAM) is associated with significant morbidity and mortality and is disproportionately distributed mainly in developing countries. In Nigeria, the prevalence of SAM in the North-Western region of the country is significantly higher than the national average. In this study, we identified risk factors for SAM in North-Western Nigeria. Identifying such risk factors would be helpful in developing local preventive strategies and providing insights for broader SAM control programs in other high-burden country settings. METHODS: We performed post hoc data analysis, comparing baseline socio-demographic and household-level risk factors in a cohort of 1011 children aged between 6 and 59 months who either had SAM or were well-nourished children. We defined nutritional status using the World Health Organization (WHO) reference standards and investigated the association between SAM and our identified risk factors using multivariable logistic regression model. RESULTS: Children aged between 12 and 23 months [adjusted odds ratio (AOR) 2.95, 95% confidence interval (CI) 1.99-4.38], household who reared domestic animals (AOR 1.94, 95% CI 1.40-2.69) and those from polygamous households (AOR 1.91, 95% CI 1.33-2.74) had significantly increased odds of developing SAM. Parental education and being on the household diet reduced the odds of having SAM. CONCLUSIONS: Our findings suggest the need to develop optimal complementary feeding nutrition programs and promote adult and general education in our community. Cultural and feeding practices in local polygamous households also need further investigation to understand the association between polygamy with SAM.

A comparative cross-sectional study of prevalence and intensity of soil-transmitted helminthic infection between healthy and severe acutely malnourished pre-school aged children in Kano, Northern Nigeria.

BACKGROUND: Soil-transmitted helminthic (STH) infections are common in Sub-Saharan Africa. One method used for control of these helminths is mass anti-helminthic administration in populations at risk of STH infections. In this regard, empiric treatment of children with Severe Acute Malnutrition (SAM) for STH infection is practiced in this region. It is however unclear if children with SAM suffer more from STH infection than healthy children. The objective of this study was to compare prevalence and intensity of STH infection between pre-school aged children with SAM and healthy children. METHODS: We approached 1114 pre-school aged children attending care in two health facilities in Kano, Nigeria to partake in this study. Of this number, we recruited 620 (55.7%) children, comprising 310 well-nourished children from well-baby clinics and 310 children with SAM from Community Management for Acute Malnutrition (CMAM) centres in these facilities. We assessed their nutritional status using World Health Organisation (WHO) growth charts and collected stool samples which we analysed using Formal-Ether Concentration technique to identify STH infection and Stoll's technique to assess intensities of STH infection. We fitted a logistic regression model to determine if there was any association between nutrition status and helminthic infection, adjusting for the confounding effects of socio-economic status and age. We compared intensity of STH infection (measured as eggs per gram of faeces) between both nutrition groups using the independent t-test. RESULTS: Overall STH prevalence in our population was low (2.7%) and we found no significant association between nutritional status and presence of STH infection (OR = 1.10, 95% CI 0.38 to 3.21). Majority of our study participants had either low or moderate (94.2%) and there was no statistically significant difference between intensity of STH infection (t value = - 1.52, P value = 0.13) in children with SAM and those who were well-nourished. CONCLUSIONS: The overall STH prevalence among pre-school children was low in Kano and we did not find prevalence and intensity of STH infection to differ significantly between preschool children with SAM and well-nourished children. Our findings confirm the WHO recommendation that at low levels of prevalence and intensity, interventions to control STH are unnecessary.

Identifying gaps in global evidence for nurse staffing and patient care outcomes research in low/middle-income countries: an umbrella review.

OBJECTIVE: To identify nurse staffing and patient care outcome literature in published systematic reviews and map out the evidence gaps for low/middle-income countries (LMICs). METHODS: We included quantitative systematic reviews on nurse staffing levels and patient care outcomes in regular ward settings published in English. We excluded qualitative reviews or reviews on nursing skill mix. We searched the Cochrane Register of Systematic Reviews, the Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports, Medline, Embase and Cumulative Index to Nursing and Allied Health Literature from inception until July 2021. We used the A Measurement Tool to Assess Systematic Reviews -2 (AMSTAR-2) criteria for risk of bias assessment and conducted a narrative synthesis. RESULTS: From 843 papers, we included 14 in our final synthesis. There were overlaps in primary studies summarised across reviews, but overall, the reviews summarised 136 unique primary articles. Only 4 out of 14 reviews had data on LMIC publications and only 9 (6.6%) of 136 unique primary articles were conducted in LMICs. Only 8 of 23 patient care outcomes were reported from LMICs. Less research was conducted in contexts with staffing levels that are typical of many LMIC contexts. DISCUSSION: Our umbrella review identified very limited data for nurse staffing and patient care outcomes in LMICs. We also identified data from high-income countries might not be good proxies for LMICs as staffing levels where this research was conducted had comparatively better staffing levels than the few LMIC studies. This highlights a critical need for the conduct of nurse staffing research in LMIC contexts. LIMITATIONS: We included data on systematic reviews that scored low on our risk of bias assessment because we sought to provide a broad description of the research area. We only considered systematic reviews published in English and did not include any qualitative reviews in our synthesis. PROSPERO REGISTRATION NUMBER: CRD42021286908.

A cross-sectional study of prevalence and risk factors for stunting among under-fives attending acute malnutrition treatment programmes in north-western Nigeria: Should these programmes be adapted to also manage stunting?

BACKGROUND: Stunting and severe wasting can co-occur in under-fives, predisposing them to increased risks for morbidity and mortality. The Community Management of Acute Malnutrition (CMAM) programme, which provides outpatient malnutrition care for severely wasted children, has been successful at managing severe wasting, but there are limited data on stunting among entrants into these programmes. METHODS: We performed secondary analysis of data collected from attendees of two CMAM centres in north-western Nigeria. Using WHO reference standards, we determined the prevalence of concurrent stunting (height/length-for-age <-2 SD) among severely wasted children (weight-for-height z-scores <-3 SD). We identified individual and household-level risk factors for concurrent stunting using multivariable logistic regression analysis. RESULTS: Our cohort comprised 472 severely wasted children and the majority (82.8%) were stunted. Age groups of 12-23 mo (adjusted OR [AOR]=2.38, 95% CI 1.26 to 4.48) and 24-35 mo (AOR=7.81, 95% CI 1.99 to 30.67), male gender (AOR=2.51, 95% CI 1.43 to 4.39) and attending the rural malnutrition clinic (AOR=3.08, 95% CI 1.64 to 5.79) were associated with a significantly increased probability of stunting. CONCLUSIONS: Stunting prevalence is high among severely wasted children attending CMAM programmes in north-western Nigeria. Policymakers need to adapt these treatment programmes to also cater for stunting, taking into account practical programmatic realities such as available expertise and scarce resource allocation.

Missed nursing care in acute care hospital settings in low-middle income countries: a systematic review protocol.

Background:  Missed nursing care (care left undone or task incompletion) is viewed as an important early predictor of adverse patient care outcomes and is a useful indicator to determine the quality of patient care. Available systematic reviews on missed nursing care are based mainly on primary studies from developed countries, and there is limited evidence on missed nursing care from low-middle income countries (LMICs). We propose conducting a systematic review to identify the magnitude of missed nursing care and document factors and reasons associated with this phenomenon in LMIC settings. Methods and analysis:  This protocol was developed using the Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols (PRISMA-P). We will conduct literature searching across the Ovid Medline, Embase and EBSCO Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases, from inception to 2021. Two independent reviewers will conduct searches and data abstraction, and discordance will be handled by discussion between both parties. The risk of bias of the individual studies will be determined using the Newcastle-Ottawa Scale (NOS). Ethics and dissemination: Ethical permission is not required for this review as we will make use of already published data. We aim to publish the findings of our review in peer-reviewed journals PROSPERO registration number: CRD42021286897 (27 th October 2021).

Nurse staffing and patient care outcomes: protocol for an umbrella review to identify evidence gaps for low and middle-income countries in global literature.

Background: Adequate staffing is key to the delivery of nursing care and thus to improved inpatient and health service outcomes. Several systematic reviews have addressed the relationship between nurse staffing and these outcomes. Most primary studies within each systematic review are likely to be from high-income countries which have different practice contexts to low and middle-income countries (LMICs), although this has not been formally examined. We propose conducting an umbrella review to characterise the existing evidence linking nurse staffing to key outcomes and explicitly aim to identify evidence gaps in nurse staffing research in LMICs. Methods and analysis: This protocol was developed using the Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols (PRISMA-P). Literature searching will be conducted across Ovid Medline, Embase and EBSCO Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases. Two independent reviewers will conduct searching and data abstraction and discordance will be handled by discussion between both parties. The risk of bias of the individual studies will be performed using the AMSTAR-2 . Ethics and dissemination: Ethical permission is not required for this review as we will make use of already published data. We aim to publish the findings of our review in peer-reviewed journals. PROSPERO registration number: CRD42021286908.

A Prospective Cohort Study of the Clinical Predictors of Bacteremia in Under-Five Children With Acute Undifferentiated Fever Attending a Secondary Health Facility in Northwestern Nigeria.

BACKGROUND: Children with acute febrile illness with no localizing signs often receive antibiotics empirically in most resource-poor settings. However, little is known about the burden of bacteremia in this category of patients, and an appraisal is thus warranted. This will guide clinical practice and promote rational antibiotics use. METHODS: We prospectively followed up 140 under-five children who presented with acute undifferentiated fever at the emergency/outpatient pediatric unit of a secondary healthcare facility. Baseline clinical and laboratory information was obtained and documented in a structured questionnaire. We compared baseline characteristics between participants with bacteremia and those without bacteremia. We further fitted a multivariable logistic regression model to identify factors predictive of bacteremia among the cohort. RESULT: The prevalence of bacteremia was 17.1%, and Salmonella Typhi was the most frequently (40.9%) isolated pathogen. The majority (78.6%) of the study participants were managed as outpatients. The participants who required admission were four times more likely to have bacteremia when compared to those managed as outpatients (AOR 4.08, 95% CI 1.19 to 14.00). There is a four times likelihood of bacteremia (AOR 4.75, 95% CI 1.48 to 15.29) with a fever duration of beyond 7 days. Similarly, participants who were admitted with lethargy were six times more likely to have bacteremia (AOR 6.20, 95% CI 1.15 to 33.44). Other significant predictors were tachypnea and lymphopenia. CONCLUSION: Among under-five children with acute undifferentiated fever, longer duration of fever, lethargy, inpatient care, tachypnea, and lymphopenia were the significant predictors of bacteremia.

Conducting clinical research in a resource-constrained setting: lessons from a longitudinal cohort study in The Gambia.

Clinical research conducted to Good Clinical Practice (GCP) standards is increasingly being undertaken in resource-constrained low-income and middle-income countries (LMICs) settings. This presents unique challenges that differ from those faced in high-income country (HIC) contexts, due to a dearth of infrastructure and unique socio-cultural contexts. Field experiences by research teams working in these LMIC contexts are thus critical to advancing knowledge on successful research conduct in these settings. The Medical Research Council Unit The Gambia at London School of Hygiene and Tropical Medicine has operated in The Gambia, a resource-constrained LMIC for over 70 years and has developed numerous research support platforms and systems. The unit was the lead clinical collaborator in a recently completed Expanded Program on Immunization Consortium (EPIC) study, involving a multicountry collaboration across five countries including the USA, Canada, Belgium, Papua New Guinea and The Gambia. The EPIC study recruited and completed follow-up of 720 newborn infants over 2 years. In this paper, we provide in-depth field experience covering challenges faced by the Gambian EPIC team in the conduct of this study. We also detail some reflections on these challenges. Our findings are relevant to the international research community as they highlight practical day-to-day challenges in conducting GCP standard clinical research in resource-constrained LMIC contexts. They also provide insights on how study processes can be adapted early during research planning to mitigate challenges.

Postnatal Outcomes and Risk Factors for In-Hospital Mortality among Asphyxiated Newborns in a Low-Resource Hospital Setting: Experience from North-Central Nigeria.

Background: Birth asphyxia accounts for a third of global newborn deaths and 95 percent of these occur in low-resource settings. A key to reducing asphyxia-related deaths in these settings is improving care of these newborns and this requires an understanding of factors associated with adverse outcomes. Objectives: In this study, we report outcomes and risk factors for mortality among newborn infants with birth asphyxia admitted to a typical low-resource hospital setting. Methods: We prospectively followed up 191 asphyxiated newborn infants admitted to a referral tertiary hospital in North-central Nigeria. At baseline, care-givers completed a structured questionnaire. Using univariable analysis, we compared baseline characteristics between participants who died and those who survived till discharge. We also fitted a multivariable logistic regression model to identify risk factors for mortality among the cohort. Results: Majority (60.7%) of the study participants presented to the hospital within the first six hours of life. Despite this, mortality among the cohort was 14.7% with a third dying within the first 24 hours of admission. The presence of respiratory distress at admission increased the risk for mortality (AOR = 3.73, 95% CI 1.22 to 11.35) while higher participant weight at admission decreased the risk (AOR = 0.11, 95% CI 0.03 to 0.40). Intrapartum factors such as duration of labour and maternal age, although significant on univariable analysis, were not significant on multivariable analysis. Conclusions: Hospital mortality among newborns with birth asphyxia is high in North-central Nigeria and majority of deaths occur during acute care. Respiratory distress at presentation and admission weights were identified as key risk factors for asphyxia mortality. Intrapartum factors on the other hand might have indirect effects on mortality through an increased risk for neonatal complications.

Fatal case of newborn Lassa fever virus infection mimicking late onset neonatal sepsis: a case report from northern Nigeria.

BACKGROUND: Lassa fever is a zoonotic viral infection endemic to the West Africa countries. It is highly fatal during pregnancy and as such reports of neonatal onset Lassa fever infections are rare in scientific literature. We report a fatal case of Lassa fever in a 26-day-old neonate mimicking the diagnosis of late-onset neonatal sepsis. CASE PRESENTATION: The patient is a 26-day-old neonate who was admitted with a day history of fever, poor feeding, pre-auricular lymphadenopathy and sudden parental death. He was initially evaluated for late onset neonatal sepsis. He later developed abnormal bleeding and multiple convulsions while on admission, prompting the need to evaluate for Lassa fever using reverse transcription polymerase chain reaction (RT-PCR). He died 31 h into admission and RT-PCR result was positive for Lassa fever. CONCLUSIONS: Neonatal Lassa fever infection is highly fatal and can mimic neonatal sepsis. High index of suspicion is needed particularly for atypical presentations of neonatal sepsis in Lassa fever endemic areas.

Corrigendum: Clinical Protocol for a Longitudinal Cohort Study Employing Systems Biology to Identify Markers of Vaccine Immunogenicity in Newborn Infants in The Gambia and Papua New Guinea.

[This corrects the article DOI: 10.3389/fped.2020.00197.].

Clinical Protocol for a Longitudinal Cohort Study Employing Systems Biology to Identify Markers of Vaccine Immunogenicity in Newborn Infants in The Gambia and Papua New Guinea.

Background: Infection contributes to significant morbidity and mortality particularly in the very young and in low- and middle-income countries. While vaccines are a highly cost-effective tool against infectious disease little is known regarding the cellular and molecular pathways by which vaccines induce protection at an early age. Immunity is distinct in early life and greater precision is required in our understanding of mechanisms of early life protection to inform development of new pediatric vaccines. Methods and Analysis: We will apply transcriptomic, proteomic, metabolomic, multiplex cytokine/chemokine, adenosine deaminase, and flow cytometry immune cell phenotyping to delineate early cellular and molecular signatures that correspond to vaccine immunogenicity. This approach will be applied to a neonatal cohort in The Gambia (N ~ 720) receiving at birth: (1) Hepatitis B (HepB) vaccine alone, (2) Bacille Calmette Guerin (BCG) vaccine alone, or (3) HepB and BCG vaccines, (4) HepB and BCG vaccines delayed till day 10 at the latest. Each study participant will have a baseline peripheral blood sample drawn at DOL0 and a second blood sample at DOL1,-3, or-7 as well as late timepoints to assess HepB vaccine immunogenicity. Blood will be fractionated via a "small sample big data" standard operating procedure that enables multiple downstream systems biology assays. We will apply both univariate and multivariate frameworks and multi-OMIC data integration to identify features associated with anti-Hepatitis B (anti-HB) titer, an established correlate of protection. Cord blood sample collection from a subset of participants will enable human in vitro modeling to test mechanistic hypotheses identified in silico regarding vaccine action. Maternal anti-HB titer and the infant microbiome will also be correlated with our findings which will be validated in a smaller cohort in Papua New Guinea (N ~ 80). Ethics and Dissemination: The study has been approved by The Gambia Government/MRCG Joint Ethics Committee and The Boston Children's Hospital Institutional Review Board. Ethics review is ongoing with the Papua New Guinea Medical Research Advisory Committee. All de-identified data will be uploaded to public repositories following submission of study output for publication. Feedback meetings will be organized to disseminate output to the study communities. Clinical Trial Registration: Clinicaltrials.gov Registration Number: NCT03246230.