Dr. Ibrahim Rasheed Olayinka

This study has the potential to improve our understanding of the etiology and risk factors for the AKI continuum, provide evidence to support early detection and diagnosis, provide background information on the natural progression and outcomes of this continuum, and provide information on optimal management strategies. In addition, a better understanding of the risk factors and underlying mechanisms may inform evidence-based, population-specific preventive strategies. Objective To assess the continuum of AKI, the incidence, risk factors and outcomes in Nigerian neonates. Conclusion The incidence of neonatal AKI, acute kidney disease, and progression to CKD from this study will be compared with reports from high-income countries to describe the variability in the epidemiology of neonatal AKI continuum. This will lay the groundwork for advocacy and intervention to improve neonatal AKI outcomes in Nigeria. Future interventional studies on neonatal AKI in the specified population may use this study’s findings as historical controls.

Abstract Background Evidence exists as to the criticality of the first 24 h in the management of cerebral malaria. The morbidity and the mortality rate (35%) with the current intravenous monotherapy for the initial treatment of cerebral malaria are unacceptably high. Combination therapy and a shorter course of effective medication have been shown to improve outcomes in human participants in the treatment of other diseases. This study outlines a protocol to conduct a triple blinded parallel randomized controlled trial on cerebral malaria using dual intravenous medications compared to the current standard of monotherapy. Methods This is a parallel multi-site randomized controlled superiority triple blinded trial consisting of intravenous artesunate plus quinine and a control arm of intravenous artesunate only. Eligible and assenting children aged 6 months to 17 years will be recruited from 4 tertiary hospitals by random selection from the list of tertiary hospitals in Nigeria. Participants will be randomized and assigned in parallel into two arms using random numbers generated from GraphPad Prism (version 9) by a clinical pharmacologist who has no link with the investigators, the patients, or the statistician. The primary measurable outcome is survival at 12, 24, and 48 h post-randomization. A composite secondary outcome consists of the number of children that regained consciousness, parasitaemia and defervescence at 12 and 24 h post-randomization and haematological and inflammatory markers at 24 and 48 h post-randomization. Adverse events both solicited and unsolicited are recorded all through the study post-randomization. The study is approved by the State Research Ethics Review Committee. Data analysis will be performed in GraphPad Prism version 9. Discussion The outcome of this analysis will give insight into the efficacy and safety of dual intravenous antimalaria in the treatment of cerebral malaria among Nigerian children compared with the standard of care. The safety profile of this intervention will also be highlighted. This may help inform physicians on the optimal treatment for cerebral malaria to improve outcomes and reduce recrudescence and treatment failure. Trial registration Pan Africa Clinical Trial Registry PACTR202102893629864. 23/02/2021.