Explore the vast range of titles available.

Background Nigeria has one of the highest under-five mortality rates in the world. Identifying the causes of these deaths is crucial to inform changes in policy documents, design and implementation of appropriate interventions to reduce these deaths. This study aimed to provide national and zonal-level estimates of the causes of under-five death in Nigeria in the 2013–2018 periods. Methods We conducted retrospective inquiries into the cause of deaths of 948 neonates and 2,127 children aged 1–59 months as identified in the 2018 Nigeria Demographic and Health Survey (NDHS). The verbal autopsy asked about signs and symptoms during the final illness. The Physician Coded Verbal Autopsy (PCVA) and Expert Algorithm Verbal Autopsy (EAVA) methods were employed to assign the immediate and underlying cause of deaths to all cases. Result For the analysis, sampling weights were applied to accommodate non-proportional allocation. Boys accounted for 56 percent of neonatal deaths and 51.5 percent of the 1–59-months old deaths. About one-quarter of under-5 mortality was attributed to neonatal deaths, and 50 percent of these neonatal deaths were recorded within 48 h of delivery. Overall, 84 percent of the under-5 deaths were in the northern geopolitical zones. Based on the two methods for case analysis, neonatal infections (sepsis, pneumonia, and meningitis) were responsible for 44 percent of the neonatal deaths, followed by intrapartum injury (PCVA: 21 percent vs. EAVA: 29 percent). The three main causes of death in children aged 1–59 months were malaria (PCVA: 23 percent vs. EAVA: 35 percent), diarrhoea (PCVA: 17 percent vs. EAVA: 23 percent), and pneumonia (PCVA: 10 percent vs. EAVA: 12 percent). In the North West, where the majority of under-5 (1–59 months) deaths were recorded, diarrhoea was the main cause of death (PCVA: 24.3 percent vs. EAVA: 30 percent). Conclusion The causes of neonatal and children aged 1–59 months deaths vary across the northern and southern regions. By homing on the specific causes of mortality by region, the study provides crucial information that may be useful in planning appropriately tailored interventions to significantly reduce under-five deaths in Nigeria.

Bacterial infection is one of the leading causes of mortality in young infants globally. The standard practice to manage young infants with any sign of possible serious bacterial infection (PSBI) is in a hospital setting with parenteral antibiotics, which may not be feasible for majority of cases in most low resource settings. The World Health Organization developed a guideline on management of PSBI in young infants when referral is not feasible in 2016. We conducted implementation research in selected communities in Zaria Local Government Areas of Kaduna State with an estimated population of 50,000 with the aim of understanding how to implement the WHO PSBI treatment guideline to achieve high coverage with low case fatality and treatment failure rates. Implementation was within the programmatic settings using existing health structure. We conducted policy dialogue with decision makers to adapt the recommendations to their social, cultural and programmatic context in Nigeria, held orientation meetings with program managers, built capacity of the health workers and supported the implementation within the health system. We supported a non-government organization to conduct community sensitization to promote care seeking and adherence to treatment advice. The research team collected data systematically on all young infants identified to have PSBI, the treatment they received and the clinical outcome. Between April 2016 and March 2017, we identified 347 young infants up to 2 months of age with signs of PSBI who received treatment either as an outpatient or in a hospital among 2,154 births in the study population. The coverage of PSBI treatment in the study area was 95.5% assuming that 10% of all births have an episode of PSBI in the first two months of life. Most (89%) sick young infants with PSBI were identified by the community-oriented resource persons and sent to the Primary Health Care Centres (PHCs). Most families (97%) refused referral and were treated at a primary health care centre on outpatient basis. There were 12 deaths (3.5%) and 17 non-death treatment failures (4.9%) in 343 infants in whom an outcome could be ascertained. While non-death treatment failure rate was highest in 0-6-day infants with fast breathing (14.4%), case fatality was highest in those with signs of critical illness (20%). We have demonstrated that outpatient treatment strategy for young infants with PSBI when referral is not feasible is implementable within the programmatic settings, achieving very high population coverage and relatively low treatment failure and case fatality rates. Implementation at scale will require government's commitment to strengthen the health system with trained, motivated health care providers and necessary commodities.

Background Nigeria’s under-five health outcomes have improved over the years, but the mortality rates remain unacceptably high. The qualitative component of Nigeria’s 2019 verbal and social autopsy (VASA) showed that caregivers’ health beliefs about causes of illnesses and efficacious treatment options contribute to non-use/delay in use of facility-based healthcare for under-five children. This study explored how these health beliefs vary across zones and how they shape how caregivers seek healthcare for their under-five children. Methods Data for this study come from the qualitative component of the 2019 Nigeria VASA, comprising 69 interviews with caregivers of under-five children who died in the five-year period preceding the 2018 Nigeria Demographic and Health Survey (NDHS); and 24 key informants and 48 focus group discussions (FGDs) in 12 states, two from each of the six geo-political zones. The transcripts were coded using predetermined themes on health beliefs from the 2019 VASA (qualitative component) using NVivo. Results The study documented zonal variation in belief in traditional medicine, biomedicine, spiritual causation of illnesses, syncretism, and fatalism, with greater prevalence of beliefs discouraging use of facility-based healthcare in the southern zones. Driven by these beliefs and factors such as availability, affordability, and access to and perceived quality of care in health facilities, caregivers often choose one or a combination of traditional medicines, care from medicine vendors, and faith healing. Most use facility-based care as the last option when other methods fail. Conclusion Caregivers’ health beliefs vary by zones, and these beliefs influence when and whether they will use facility-based healthcare services for their under-five children. In Nigeria’s northern zones, health beliefs are less likely to deter caregivers from using facility-based healthcare services, but they face other barriers to accessing facility-based care. Interventions seeking to reduce under-five deaths in Nigeria need to consider subnational differences in caregivers’ health beliefs and the healthcare options they choose based on those beliefs.

Background A pilot programme of Cohort Event Monitoring (CEM) was conducted across the six geopolitical zones of Nigeria on patients treated for uncomplicated malaria with artemisinin-based combination therapy (ACT). The emergence and spread of malaria parasites resistant to commonly available antimalarial drugs necessitated a shift in policy for malaria treatment by the Federal Government from the use of chloroquine and sulphadoxine-pyrimethamine (SP) as first-line treatments to ACTs. Initial reports following deployment of ACTs in clinical settings raised safety concerns regarding their use. Although artemisinin and its derivatives are generally thought to be safe, there are currently few or no data on their safety among populations in Nigeria. Objectives The main objectives of the CEM programme were to proactively determine the adverse event (AE) profile of artesunate/amodiaquine (AA) and artemether/lumefantrine (AL) in real-life settings and to find out the factors predisposing to AEs. Methods The CEM study was observational, longitudinal, prospective, and inceptional. Patients were observed in real-life situations. It was conducted in six public health facilities in Nigeria on patients with a clinical diagnosis of uncomplicated malaria treated with ACTs. Patients were prescribed one of the ACTs on an alternate basis as they enrolled into the programme. Follow-up reviews were undertaken on days 3 and 7 following commencement of ACT treatment. At follow-up, patients were evaluated for any clinical event that they might have experienced following the use of the ACTs. We report the result of this initial pilot in which 3,010 patients treated for uncomplicated malaria with AA or AL were enrolled. Results The seven most common AEs seen were general body weakness 25.0/36.6 % (AL/AA); dizziness 11.9/17.2 % (AL/AA); vomiting 8.0/10.2 % (AL/AA); abdominal pain 8.5/7.2 % (AL/AA); insomnia 6.3/5.9 % (AL/AA); body pains 3.4/5.2 (AL/AA) %; anorexia 8.5/4.6 % (AL/AA). Most adverse events occurred from day 1 and peaked by day 2 and 3 of medication with the mean duration of events being 3 days. By the end of the follow-up visit on day 7, the AEs had resolved in the majority of patients. Adverse events were more common in the AA group than AL revealing a better safety profile for AL ( p  < 0.001). Both ACTs demonstrated good ability to resolve the clinical symptoms of uncomplicated malaria. Conclusion In conclusion, this pilot CEM programme suggests that adverse events with ACTs were common. However, serious life-threatening events were not common. It appears that ACTs have a tolerable safety profile among Nigerians.

Background: Rotavirus infection is a significant cause of gastroenteritis in developing countries and, in severe cases even leads to death. The impact of rotavirus vaccine introduction in reducing the rotavirus disease burden in children was well known. The study was aimed to determine the prevalence and clinical characteristics of rotavirus gastroenteritis before the introduction of rotavirus vaccine into Nigeria's routine immunization program. Materials and Methods: We conducted a cross-sectional hospital-based study involving 735 children aged 0-59 months with acute gastroenteritis hospitalized at the Ahmadu Bello University Teaching Hospital Zaria from September 2017 to August 2020. Relevant sociodemographic and clinical data were obtained and entered into the World Health Organization standardized case investigation forms. Stool specimens were tested for rotavirus Group A antigen using the ProSpecT™ Rotavirus Microplate Assay by Thermoscientific Oxoid Microbiology UK. Results: One hundred and fifty-three stool samples tested positive for rotavirus giving a prevalence of 20.8%. One hundred and two (66.7%) children with rotavirus gastroenteritis were infants. There were 87 males and 66 females with M: F ratio of 1.3:1. Only 30 (19.6%) children with rotavirus-associated diarrhea presented with severe dehydration. The presence of vomiting was significantly associated with rotavirus diarrhea (P = 0.001). More cases of rotavirus diarrhea occurred in September through February. None of the studied children were vaccinated against rotavirus. Conclusion: The prevalence of rotavirus diarrhea remains high in this study. Infants were recognized as a high-risk group, and none of them were vaccinated against rotavirus and this underscores the urgent need for implementing the rotavirus vaccine in the national vaccination program to reduce the disease burden in the country. Résumé Contexte: L'infection à rotavirus est une cause importante de gastro-entérite dans les pays en développement et, dans les cas graves, entraîne même la mort. L'impact de l'introduction du vaccin antirotavirus pour réduire le fardeau de la maladie à rotavirus chez les enfants était bien connue. L'étude visait à déterminer la prévalence et les caractéristiques cliniques de la gastro-entérite à rotavirus avant l'introduction du vaccin antirotavirus dans le programme de vaccination systématique du Nigéria. Matériels et méthodes: Nous avons mené une étude hospitalière transversale portant sur 735 enfants âgés de 0 à 59 mois atteints de gastro-entérite aiguë. hospitalisé à l'hôpital universitaire Ahmadu Bello Zaria de septembre 2017 à août 2020. Données sociodémographiques et cliniques pertinentes les données ont été obtenues et saisies dans les formulaires normalisés d'investigation de cas de l'Organisation mondiale de la santé. Des échantillons de selles ont été testés pour le rotavirus Antigène du groupe A utilisant le test sur microplaque ProSpecT™ Rotavirus par Thermoscientific Oxoid Microbiology UK. Résultats: cent cinquante trois les échantillons de selles ont été testés positifs pour le rotavirus donnant une prévalence de 20,8 %. Cent deux (66,7 %) enfants atteints de gastro-entérite à rotavirus ont été nourrissons. Il y avait 87 hommes et 66 femmes avec un rapport M:F de 1,3:1. Seuls 30 (19,6 %) enfants atteints de diarrhée à rotavirus ont présenté déshydratation sévère. La présence de vomissements était significativement associée à la diarrhée à rotavirus (P = 0,001). Plus de cas de diarrhée à rotavirus se sont produits de septembre à février. Aucun des enfants étudiés n'a été vacciné contre le rotavirus. Conclusion: La prévalence de la diarrhée à rotavirus reste élevé dans cette étude. Les nourrissons ont été reconnus comme un groupe à haut risque et aucun d'entre eux n'a été vacciné contre le rotavirus, ce qui souligne la nécessité urgente de mettre en œuvre le vaccin antirotavirus dans le programme national de vaccination afin de réduire la charge de morbidité dans le pays. Mots-clés: Gastro-entérite aiguë, diarrhée à rotavirus, vaccin à rotavirus, Zaria

Hospitalisation and a seven-day injectable antibiotics course are recommended by the World Health Organization (WHO) to treat suspected clinical neonatal sepsis / possible serious bacterial infection (PSBI). Some infants presenting with PSBI signs associated with a moderate risk of mortality may only need a two-day hospitalisation followed by outpatient care treatment with oral antibiotics to complete seven days of antibiotics. A multi-centre, individually randomised, open-label trial will be conducted in seven sites in six countries: Bangladesh, Ethiopia, India (two sites), Nigeria, Pakistan and Tanzania. A common protocol will be used with the same study design, including the participants, intervention, comparison, outcomes, quality control, and analysis procedures. 0-59 days old infants presenting with moderate-mortality risk signs (low body temperature (<35.5°C), movement only when stimulated, stopped feeding well) or two or more signs of clinical severe infection (CSI) will be assessed and pre-enrolled. After 48 hours of hospital stay, clinically stable infants with a negative C-reactive protein test will be randomised either to hospital discharge on oral amoxicillin (intervention) or continued hospitalisation (control) arm. The intervention arm will receive oral amoxicillin for five days, whereas the control arm will receive injection gentamicin plus injection ampicillin for five more days plus supportive therapy if needed. We plan to enrol 5250 eligible young infants, 2625 infants in each of the two study arms. An experienced, well-trained independent outcome assessor will visit all enrolled cases on days 4, 8 and 15 after the initiation of treatment to assess the study outcomes in both intervention and control arms. The primary outcome of poor clinical outcome defined as death between randomisation and day 15 of initiation of treatment, deterioration during the 7-day treatment period, or persistence of the presenting sign of CSI at the end of the 7-day treatment period will be compared to assess if an early discharge and outpatient treatment leads to superior or at least non-inferior clinical outcome than continued inpatient treatment. The harmonisation of activities, including methods and processes, will be carried out diligently. Central training will be conducted by the WHO coordinating team, a central data coordination centre to collate all data, standardisation exercises for all clinical signs and internal and external monitoring. All the selected sites have extensive research experience. Through regular online and physical meetings, data-based monitoring, and physical site visits by WHO monitors, quality assurance and harmonisation will be ensured. This trial has been approved by the WHO and local site institutional ethics committees. If the results show that young infants with moderate-mortality risk PSBI signs can be safely and effectively treated on an outpatient basis after a shorter hospital stay, it will reduce the burden on the hospitals, potentially reduce nosocomial hospital infections and increase access to treatment for families with poor access to health facilities. It may also reduce the health system costs (human and materials) and allow the overburdened hospitals to pay more attention to critically ill young infants. In addition, this evidence will contribute to making a case for reviewing the WHO PSBI guideline. International Standard Randomised Controlled Trial Number, ISRCTN16872570.

World Health Organization (WHO) recommends hospitalisation and injectable antibiotics for clinical sepsis / possible serious bacterial infection (PSBI) in young infants up to two months of age. However, some young infants with low-mortality risk signs of PSBI may not require hospitalisation, for which evidence needs to be generated. This is a protocol for a multicentre, individually randomised, open-label trial that will be conducted in seven sites in six countries Bangladesh, Ethiopia, India (two sites), Nigeria, Pakistan and Tanzania. All sites will use this common protocol with the same study design, inclusion of participants, intervention, comparison, and outcomes, as well as quality control and analysis procedures to contribute to the overall sample size. All young infants (age <60 days) presenting at study hospitals with any single low-mortality risk sign (high body temperature ≥38°C, severe chest indrawing, or fast breathing of ≥60 breaths per minute in <7 days old infants) will be randomised to either outpatient care with injectable gentamicin for two days and oral amoxicillin for seven days (intervention) or inpatient care with injection gentamicin plus injection ampicillin along with supportive treatment, where needed, for seven days (control). We plan to enrol 7000 eligible young infants, 3500 infants in each of the two study arms. A trained and standardised independent outcome assessor will visit all enrolled cases on days two, four, eight and 15 post-randomisation to assess the study outcomes in both intervention and control groups. The primary outcome of poor clinical outcome, defined as death within two weeks of initiation of treatment, deterioration during the 7-day treatment period, or persistence of the presenting sign at the end of the 7-day treatment period, will be compared to assess if the outpatient treatment leads to superior or at least non-inferior clinical outcome than inpatient treatment. The selected sites have extensive research experience. The methods and all study procedures will be harmonised through central training of research staff by WHO, standardisation exercises for clinical signs, central data coordination centre and internal and external monitoring. Continuous evaluation of the enrolment by the sites will be carried out through regular calls, databased monitoring, and site visits by WHO monitors. This trial has received ethical approvals from the WHO and local site institutional ethics committees. If the results show that young infants with any single low-mortality risk PSBI sign can be effectively and safely treated on an outpatient basis, it may substantially increase access to treatment for infants and families with poor access to health facilities. It may also reduce the human, financial and material costs to the health system and allow the currently overloaded health facilities to focus on more critically ill infants. This evidence will contribute toward making a case for reviewing the current WHO PSBI management guideline. International Standard Randomised Controlled Trial Number ISRCTN44033252.