Neonatal sepsis is a significant cause of mortality and morbidity in low- and middle-income countries. To deliver high-quality data studies and inform future trials, it is crucial to understand the ...challenges encountered when managing global multi-centre research studies and to identify solutions that can feasibly be implemented in these settings. This paper provides an overview of the complexities faced by diverse research teams in different countries and regions, together with actions implemented to achieve pragmatic study management of a large multi-centre observational study of neonatal sepsis. We discuss specific considerations for enrolling sites with different approval processes and varied research experience, structures, and training. Implementing a flexible recruitment strategy and providing ongoing training were necessary to overcome these challenges. We emphasize the attention that must be given to designing the database and monitoring plans. Extensive data collection tools, complex databases, tight timelines, and stringent monitoring arrangements can be problematic and might put the study at risk. Finally, we discuss the complexities added when collecting and shipping isolates and the importance of having a robust central management team and interdisciplinary collaborators able to adapt easily and make swift decisions to deliver the study on time and to target. With pragmatic approaches, appropriate training, and good communication, these challenges can be overcome to deliver high-quality data from a complex study in challenging settings through a collaborative research network.
This research prioritization aimed to identify major research gaps in maternal, newborn, child and adolescent health (MNCAH) to help mitigate the direct and indirect effects of the COVID-19 pandemic.
...We adapted the Child Health and Nutrition Research Initiative methodology. We defined scope, domains, themes and scoring criteria. We approached diverse global experts via email to submit their research ideas in MNCAH and MNCAH-related cross-cutting/health systems area. We curated the research ideas as research questions (RQs) and sent them to the consenting experts for scoring via the online link. For each RQ, the research priority score (RPS) was calculated as an average of individual criterion scores and ranked based on RPS in each area.
We identified top-ranked 10 RQs in each maternal, newborn, and child and adolescent health and 5 in the cross-cutting/health systems area. In maternal health, indirect effects on care, measures to improve care, health risks and outcomes, and preventing and managing SARS-CoV-2 infection/COVID-19 disease were priority RQs. In newborn health, clinical characterization and managing SARS-CoV-2 infection/COVID-19 disease, mode of transmission and interventions to prevent transmission were the focus. For child and adolescent health, top-ranked RQs were indirect effects on care, clinical status and outcomes, interventions to protect against SARS-CoV-2 infection/COVID-19 disease, and educational institute-related RQs. The cross-cutting RQs were the effects of the pandemic on availability, access, care-seeking and utilization of MNCAH services and potential solutions.
We call on partners, including governments, non-governmental organizations, research institutes, and donors, to address this urgent research agenda.
BACKGROUND:Newborns and young infants suffer high rates of infections in South Asia and sub-Saharan Africa. Timely access to appropriate antibiotic therapy is essential for reducing mortality. In an ...effort to develop community case management guidelines for young infants, 0–59 days old, with clinically diagnosed severe infections, or with fast breathing, 4 trials of simplified antibiotic therapy delivered in primary care clinics (Pakistan, Democratic Republic of Congo, Kenya and Nigeria) or at home (Bangladesh and Nigeria) are being conducted.
METHODS:This article describes the scientific rationale for these trials, which share major elements of trial design. All the trials are in settings of high neonatal mortality, where hospitalization is not feasible or frequently refused. All use procaine penicillin and gentamicin intramuscular injections for 7 days as reference therapy and compare this to various experimental arms utilizing comparatively simpler combination regimens with fewer injections and oral amoxicillin.
CONCLUSION:The results of these trials will inform World Health Organization policy regarding community case management of young infants with clinical severe infections or with fast breathing.
OBJECTIVE: To estimate the validity (sensitivity, specificity, and positive and negative predictive values) of a clinical algorithm as used by community health workers (CHWs) to detect and classify ...neonatal illness during routine household visits in rural Bangladesh. METHODS: CHWs evaluated breastfeeding and symptoms and signs of illness in 395 neonates selected randomly from neonatal illness surveillance during household visits on postnatal days 0, 2, 5 and 8. Neonates classified with very severe disease (VSD) were referred to a community-based hospital. Within 12 hours of CHW assessments, physicians independently evaluated all neonates seen in a given day by one CHW, randomly chosen from among 36 project CHWs. Physicians recorded symptoms and signs of illness, classified the illness, and determined whether the newborn needed referral-level care at the hospital. Physicians' identification and classification were used as the gold standard in determining the validity of CHWs' identification of symptoms and signs of illness and its classification. FINDINGS: CHWs' classification of VSD showed a sensitivity of 73%, a specificity of 98%, a positive predictive value of 57% and a negative predictive value of 99%. A maternal report of any feeding problem as ascertained by physician questioning was significantly associated (P < 0.001) with "not sucking at all" and "not attached at all" or "not well attached" as determined clinically by CHWs during feeding assessment. CONCLUSION: CHWs identified with high validity the neonates with severe illness needing referral-level care. Home-based illness recognition and management, including referral of neonates with severe illness by CHWs, is a promising strategy for improving neonatal health and survival in low-resource developing country settings.
Metodos Los ASC evaluaron las practicas de lactancia materna y los signos y sintomas de enfermedad en 395 recien nacidos seleccionados aleatoriamente mediante los sistemas de vigilancia de la ...morbilidad neonatal con ocasion de visitas domiciliarias realizadas a los 0, 2, 5 y 8 dias del nacimiento. Los recien nacidos clasificados con enfermedades muy graves (EMG) fueron derivados a un hospital comunitario. En el termino de las 12 horas siguientes a esos examenes realizados por los ASO, los medicos exploraron de forma independiente a todos los recien nacidos examinados en un determinado dia por un ASC, elegido al azar entre los 36 ASO participantes en el proyecto. Los medicos registraban los signos y sintomas de la enfermedad, clasificaban la enfermedad y determinaban si el recien nacido necesitaba atencion de referencia en el hospital. La identificacion y la clasificacion que realizaron los medicos se utilizaron como criterio de referencia para determinar la validez de la identificacion de los signos y sintomas y la clasificacion de la enfermedad realizadas por los ASC.
The Projahnmo-II Project in Mirzapur upazila (sub-district), Tangail
district, Bangladesh, is promoting care-seeking for sick newborns
through health education of families, identification and ...referral of
sick newborns in the community by community health workers (CHWs), and
strengthening of neonatal care in Kumudini Hospital, Mirzapur.
Data were drawn from records maintained by the CHWs, referral hospital
registers, a baseline household survey of recently-delivered women
conducted from March to June 2003, and two interim household surveys in
January and September 2005. Increases were observed in self-referral of
sick newborns for care, compliance after referral by the CHWs, and
care-seeking from qualified providers and from the Kumudini Hospital,
and decreases were observed in care-seeking from unqualified providers
in the intervention arm. An active surveillance for illness by the CHWs
in the home, education of families by them on recognition of danger
signs and counselling to seek immediate care for serious illness,
and improved linkages between the community and the hospital can
produce substantial increases in care-seeking for sick newborns.
A simple process based on the dual roles of both magnesium oxide (MgO) and iron oxide (FeO) with boron (B) as precursors and catalysts has been developed for the synthesis of borate composites of ...magnesium and iron (Mg2B2O5-Fe3BO6) at 1200°C. The as-synthesized composites can be a single material with the improved and collective properties of both iron borates (Fe3BO6) and magnesium borates (Mg2B2O5). At higher temperatures, the synthesized Mg2B2O5-Fe3BO6 composite is found thermally more stable than the single borates of both magnesium and iron. Similarly, the synthesized composites are found to prevent the growth of both gram-positive (Staphylococcus aureus) and gram-negative (Escherichia coli) pathogenic bacteria on all the tested concentrations. Moreover, the inhibitory effect of the synthesized composite increases with an increase in concentration and is more pronounced against S. aureus as compared to E. coli.