Carina Theresa King

Hypoxaemia - low blood oxygen (SpO2&lt

90%), is a well-established mortality risk in children. Hypoxaemic children are recommended for referral to hospital for oxygen treatment, but completing referrals in low-income settings is challenging and huge gaps in oxygen access persist. Therefore, a large proportion of hypoxaemic children go untreated, and yet, most survive. The purpose of the “Serial Oximetry for Improved Triage and Referral” - the SOfTeR study, is to improve care for hypoxaemic children in low-resource contexts. Ultimately, the project aims to reduce child mortality through the co-design of appropriate care pathways. The study will take place in Nigeria, Malawi and Sweden, to reflect diverse demographic, epidemiological and health systems contexts.Following the MRC guidelines for developing and evaluating complex interventions, the SOfTeR Project will be delivered through three sub-studies. Study 1 will involve formative work to understand which children would most benefit from referral for oxygen treatment and includes: a) secondary analysis of globally collated datasets

b) prospective cohorts of children presenting to outpatient settings in Nigeria, Malawi and Sweden over 12 months. Study 2 will co-design a new triage and referral pathway for children with policy makers, healthcare workers and caregivers in Nigeria and Malawi, focussing on the role of pulse oximetry. Study 3 will pilot this novel pathway in Nigeria and Malawi thorugh a single-arm cluster trial.

Pneumonia is a leading cause of morbidity and mortality especially among children in sub-Saharan Africa. Nigeria and Ethiopia are among the 5 countries that account for half of the under-five pneumonia deaths. Majority of the deaths from pneumonia are however preventable with early diagnosis and appropriate management. In children with pneumonia, hypoxemia is quite common and constitutes a major risk factor for death. The WHO and other leading child health agencies urge widespread access to oxygen therapy. Bubble continuous positive airway pressure (bCPAP) is a method of delivering oxygen and positive pressure into the airways thus keeping the alveoli open for improved gas exchange. While use of bCPAP devices appears safe and effective worldwide, scaling of quality bCPAP devices in low- and middle-income countries (LMICs) has been limited. This has prevented most children in LMICs from receiving life-saving non-invasive respiratory support which could have saved many lives. Achieving Sustainable Development Goal (SDG) 3.2 of the reduction of under-5 mortality to at least as low as 25 per 1,000 live births by 2030 will likely not be possible without access to innovative and low cost interventions devices such as bCPAP in LMICs. The aim of the OPT-bCPAP is to perform context-appropriate scale-up of bCPAP in settings of very high disease burden (Nigeria, Ethiopia and Malawi) using the the positive results and the lessons learned from clinical trials conducted in Ethiopia, Bangladesh and Ghana. In addition to scaling up bCPAP, we will deeply explore additional factors associated with treatment failure and mortality from severe pneumonia, we aim to generate data on adherence to treatment guidelines, healthcare-seeking behaviour, magnitude of respiratory syncytial virus infection, antimicrobial resistance, PK/PD of commonly used antibiotics and generate novel recommendations for antibiotic treatments tailored to the populations in these diverse settings.

Oxygen is an essential and life-saving medicine. The COVID-19 pandemic highlighted and exacerbated an existing global oxygen crisis, with pervasive inequities in the availability of quality oxygen services. Research into oxygen access was ranked as the highest cross-cutting priority for maternal, neonatal, and child health in recent consensus exercises, and this evidence gaps has been recognised by National Governments in a 2023 draft World Health Assembly Resolution on Oxygen Access.The purpose of our study is to provide evidence on how medical oxygen services can effectively be delivered and maintained at scale, ultimately leading to improved survival. This will be addressed through five objectives:Determine the impact of medical oxygen systems strengthening interventions on clinical practiceDetermine the impact of medical oxygen systems strengthening interventions on mortalityUnderstand the bottlenecks, challenges, and opportunities of improved medical oxygen services from a range of stakeholder perspectivesExplore how, why, and for whom oxygen systems strengthening efforts work, and whether there are unintended effectsEstablish best-practice recommendations through cross-country learningWe will address these through two studies in Nigeria and Uganda, covering an estimated 50 million people: 1) estimating oxygen impact at scale through quasi-experimental analyses

2) understanding mechanisms and processes for impact using a realist mixed-methods evaluation.