The third leading cause of death in children around the world before their fifth birthday is serious infections like sepsis and meningitis in the first 28 days of life (the neonatal period). Each year, an estimated 800,000 newborns succumb to such infections. Once a newborn becomes infected, the two key things in preventing progression of the condition to death are early recognition of the clinical signs and prompt administration of effective antibiotic treatment.
It may sound simple, but in other respects, particularly from a systems point of view, the challenges are overwhelming and further complicated by cultural, social and economic factors.
In developed countries newborns with infections receive the “gold standard” of care, which typically entails meeting or exceeding a World Health Organization (WHO) recommendation of a 10- to 14-day regimen of two antibiotics given by intramuscular injection or intravenously in a hospital setting, as anything less would be considered “unethical”. Providing the standard of care is possible because the majority of parents have access to affordable, high-quality institutional care.
However, this is not the reality for most newborns in most developing countries. More often than not, women deliver at home without the assistance of a skilled birth attendant. If their newborn develops an infection they might not recognize the warning signs promptly if at all, or they may recognize the signs but attribute them to something else such as spiritual forces. If they do recognize the illness as something they can potentially manage, they may face a plethora of logistical, cultural and economic challenges to gain access to a health worker with the skills, equipment and supplies necessary to provide the curative care their newborn needs.
Furthermore, many parents consider seeking care outside the home as unacceptable during the first few days to weeks of life, and often if they seek care they suffer “opportunity costs”, for example due to lost time at work, and face the challenges of receiving sub-standard treatment due to barriers of cost, hospital under-staffing or lack of supplies and beds, and they run the risk of being treated poorly.
In an unprecedented collaboration, the World Health Organization (WHO), Save the Children/Saving Newborn Lives (SC/SNL), The United States Agency for International Development (USAID), and the Bill & Melinda Gates Foundation (BMGF) came together with local institutions in Nigeria, Kenya, the Democratic Republic of Congo, Bangladesh and Pakistan to collaborate with the common understanding that to significantly reduce neonatal mortality, new innovative solutions for recognizing and treating newborn infections needed to be developed. In 2007, a technical advisory group of partners recommended the development of large-scale clinical trials to evaluate the possibility of providing simplified antibiotic regimens for newborns with infections outside the hospital setting.
Even though it took almost five years in the making, we are currently wrapping up trials in communities and primary care clinics in Democratic Republic of Congo, Kenya, Nigeria, Bangladesh and Pakistan. The ethical challenges were considerable, as we struggled to reconcile the current “standard” of care with the reality that the standard of care is so high that the majority of babies don’t receive treatment, and most families refuse treatment in their local health system as it currently exists.
In order to reconcile the ethical concerns, all families in the study were offered the standard of care in a hospital setting, and only if they refused care were they offered the simplified treatments in a health facility closer to home or at home. Simplified treatments consisted of various combinations of antibiotics given by intramuscular injections or orally, The idea that newborns with serious infections could be treated as outpatients at home or at community clinics with regimens that include oral antibiotics is a bold, paradigm-shifting hypothesis that the study teams are taking the risk to test through a rigorously designed and implemented randomized controlled trial.
The results of this study could be ground breaking, empowering parents with the opportunity to choose treatment approaches that are provided closer to home while breaking down many of the cultural, social and economic barriers they face, and giving newborns throughout low and middle income countries the chance they need to survive the newborn period. This could result in saving many of the 800,000 newborns that die each year from infections.
I write this blog as I sit in Nigeria with my colleagues to review the initial results of the study in Africa. The ability of the country teams to conduct this complex trial under extremely challenges circumstances is truly inspirational. The study involved the best possible partnership between local organizations, who truly “owned” the conduct of the study and its outcomes, and the WHO, who provided the oversight and the capacity building these organizations needed to grow and be successful. The study also allowed the Bill and Melinda Gates Foundation to step into its “sweet spot” in funding partnerships to create innovative solutions to pressing problems that require taking risks to solve.
I am very hopeful, and look forward to sharing with you our learnings as the data is published over the coming months and we turn our efforts towards disseminating the results and advocating for policy change to give every newborn the chance to receive life-saving treatment for serious infections.