Investigating Neonatal Sepsis: Anti-Infectives, Diagnostics and Guidelines used in Health sysTems across Sub-Saharan Africa - The INSIGHTS Study

Background Sepsis is a leading cause of neonatal mortality in sub-Saharan Africa (SSA), where microbiological diagnostic capacity and antibiotic access are limited. High antimicrobial resistance (AMR) rates limit the effectiveness of current treatment guidelines, with concern that available antibiotics are rarely adequate treatment for neonatal sepsis in the region.

A cross-sectional online survey was electronically distributed in English, French and Portuguese to neonatal clinicians across SSA between April and June 2025. Questions focussed on the management of neonatal sepsis including diagnostic, antibiotic and guideline use. Responses were analysed descriptively and presented as percentages of the total number of responses.

Of 169 responses (40/48 countries; 83.3%) from SSA, 71.6% were senior doctors, 88.8% managed neonatal sepsis at least weekly and 58.0% worked in central healthcare facilities. 9.0% of respondents never and 28.6% less than half of the time received blood culture results in time to impact patient care. Guidelines were almost universally used (97.6%). The commonest guideline for early-onset neonatal sepsis advised amoxicillin/ampicillin plus aminoglycosides (46.4% of responses). 50.3% of respondents had difficulties accessing antibiotics, with carbapenems and piperacillin- tazobactam least accessible. More than half of respondents (54.6%) had not attempted to author local guidelines, with insufficient local AMR data (45.6%) the most common barrier to guideline development.

This large survey highlighted widespread challenges in diagnostic and antibiotic access for neonatal sepsis in SSA. We find that clinicians rely on guidelines to guide starting antibiotics and to guide agent choice. Their practices reflect advice in global guidelines because attempts to author locally applicable guidelines are hindered by insufficient AMR data. These findings strengthen calls to improve microbiological diagnostic access and support data sharing to generate evidence-based, locally appropriate guidelines. What is already known on the topic Neonatal sepsis is a leading cause of death in sub-Saharan Africa. Amidst antimicrobial resistance (AMR) and structural barriers - limited diagnostic capacity, antibiotic access and few locally tailored guidelines, the management of sepsis is not well described, leaving a critical evidence gap. What this study adds This survey of neonatal clinicians in 40 of 48 countries in sub-Saharan Africa, is the most comprehensive to date. Timely diagnostic results are often unavailable, access to necessary antibiotics scarce, and clinicians rely heavily on guidelines, which are global directed rather than locally adapted, hampered by minimal AMR data. How this study might affect research, practice or policy Highlighting the importance of guidelines in clinicians’ practice must strengthen efforts to develop pan-African data sharing in neonatal sepsis, to enable locally relevant guidelines which can inform practice effectively amidst AMR and diagnostic, antibiotic and infrastructural challenges. Competing Interest Statement FF is a Trustee of Neotree, a UK registered charity that provides technology, software information, education and support to healthcare workers and medical practitioners throughout England and Wales, Malawi and Zimbabwe (charity number: 1186748). All other authors declare no competing interests. Funding Statement The study was not directly funded. Time for J.S. and D.H. was supported by the Elizabeth Blackwell Institute for Health Research, University of Bristol, with funding from North Bristol NHS Trust. FF is supported by a Wellcome Trust Early Career Award (227076/Z/23/Z). Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Health Research Ethics Committee of Stellenbosch University gave ethical approval for this work (HREC approval number: N24/10/118). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability All data produced in the present study are available upon reasonable request to the authors