Despite progress in reducing child mortality, an estimated 5.4 million children under five years of age died of preventable causes in 2017 including pneumonia (24%), diarrhoea (15%), and malaria (9%). Global inequity persists, with a mortality rate in sub-Saharan Africa that is 14 times higher than that of high-income countries. Evidence-based guidelines exist for the management of common and preventable causes of mortality, yet tools are often lacking to support their implementation.
Hypoxia, a major fatal complication of pneumonia, occurs in an estimated 13% of children with pneumonia (equivalent to 1.9 million cases per year). It is one of the strongest predictors of mortality in children under five with pneumonia and other diseases. Pulse oximetry is a cheap and non-invasive method of detecting hypoxia, and its implementation, along with access to oxygen, can reduce childhood pneumonia mortality. Yet very few primary healthcare facilities in low- and middle-income countries have access to pulse oximetry and consequently have limited capacity to appropriately detect and manage children with hypoxia.
In response to this challenge, Swiss TPH are working with PATH to evaluate the impact, cost-effectiveness and operational requirements for the introduction of pulse oximetry, supported by clinical decision support algorithms (CDSAs), to primary healthcare facilities in five countries: Kenya, Myanmar, Senegal, Tanzania and the Indian state of Uttar Pradesh (UP).
The wider project, funded by UNITAID and led by PATH is also working to:
- Engage country stakeholders around uptake and integration of pulse oximetry into Ministry of Health strategy and operational plans
- Train healthcare workers in the use of pulse oximetry and CDSAs
- Engage communities on health-seeking behaviour and referral uptake with a focus on children with severe illness
- Accelerate the introduction of multimodal (MM) pulse oximetry devices which can measure additional vital signs such as respiratory rate, temperature or haemoglobin levels through development of a target product profile and provision of market intelligence.
- Contribute to global transition and scale-up of POX, CDSAs, and MMs as part of a broader package of lifesaving child health technologies in LMICs, through engaging ‘observer countries’; development of networks; knowledge and guidance dissemination; and demonstrating the benefit of donor investment.
Swiss TPH leads the research component of the project, in conjunction with PATH and research partners in each of the five countries. This involves an impact study: a three-arm cluster randomized controlled trial in 120 facilities in India and 60 facilities in Tanzania, to pragmatically evaluate the superiority of using either pulse oximetry or pulse oximetry integrated into an CDSA compared with routine practice. The primary endpoints are the proportion of children with severe disease appropriately referred to hospital and the proportion of children with severe complications. In addition, operational research in all five countries seeks to understand the process, barriers and enablers to implementation in order to generate evidence to guide successful scale-up and policy.
The project is a cross-departmental collaboration between SCIH (Health Technology and Telemedicine Unit) and the Clinical Research Unit, in partnership with Unisanté in Lausanne. This study is the largest in its field to date and, as such, will be key in informing the international debate on interventions to improve child health.