Low-cost technologies that can save the lives of newborns: Designing promising innovations for developing countries - The Center for Global Health and Development (CGHD)

Newborns Mamata gave birth to her daughter in a village in rural Haryana in Northern India with her mother-in-law's help. After a stressful, prolonged delivery, her mother-in-law could not help deliver the placenta. Meanwhile the infant was in respiratory distress. By the time Mamata's mother-in-law realized the urgency of the situation, it was nearly too late. However, she realized the need to clear the infant's nose and mouth in order for the infant to breathe normally. Today, the infant is a healthy, thriving two-month old with no medical conditions. Critical action during these early minutes prevented a potentially a life-threatening situation.

Not all deliveries have favorable outcomes. Newborns and their mothers are particularly vulnerable populations in developing countries. Overall, newborn deaths, within the first 28 days of life, account for an estimated 41 percent of children who die under-five years of age, almost all (99 percent) in low income countries. This proportion has been increasing over the past decade. This statistic indicates that not enough progress has been made in improving the health and survival of newborns. Achieving Millennium Development Goal 4 (MDG 4) of reducing deaths in children under age five years by two-thirds between 1990 and 2015, will require significant investments focused, specifically, on improving neonatal survival. More than half of all deliveries worldwide take place at home, in environments lacking basic hygiene and functioning health systems that would ensure the survival of both the mother and the newborn.

Of the estimated 135 million children born each year, more than three million newborns die within their first month of life. Ninety nine percent of all newborn and maternal deaths occur in the developing world, where there is a lack of technology in comparison to industrialized countries. In high-income countries, large medical device companies use powerful marketing strategies to ensure that medical technology is available to the vast majority of newborns, albeit at an immense financial cost.

With the growing interest in global health in recent years, health technologies for resource-poor environments have received much attention at the research and development stage. Many of these technologies are aimed at saving newborn lives. However, while many newborn health devices are in development or have even reached the stage of prototype production, a majority of technologies falter or remain in the research and development stages. A range of barriers continues to keep them from wide, efficient distribution and use in these disadvantaged areas.

Simple interventions such as hand washing by mother and birth attendant (in cases where there is one) and drying and covering of the infant to keep him or her warm are simple, cost little and are effective. Another such simple intervention is breastfeeding. UNICEF, and others, emphasize that optimal breastfeeding practices, especially early and exclusive breastfeeding until six months of age, probably has the single greatest potential impact on child survival, with the potential to prevent 1.4 million under-five deaths in the developing world. Infants who are breastfed have a six-fold greater chance of survival compared to those who are not breastfed. In addition, breastfeeding greatly enhances the immune system of newborns, therefore, the risk of illness of these infants is significantly reduced. However, most recent data indicates that current practices are far from being ideal. Only 36 percent of 0-5 month olds in the developing world are exclusively breastfed, and of this 36 percent, only 43 percent start breastfeeding within the first hour after birth, as recommended. In developed countries, these numbers are even worse.

Likewise, immunization of pregnant women against tetanus and other vaccine-preventable diseases has been shown to be one of the most effective and cost-effective interventions to ensure the health of newborns. The immunization rates of pregnant women, in low-income countries, have been found to be extremely low. Therefore, only making this medical intervention available to more mothers and children can drastically reduce their deaths.

In addition to increasing the use of simple interventions such as breastfeeding, experts agree that the major causes of infant mortality must be addressed by offering sick and at-risk infants appropriate health technology. The most common causes of newborn deaths, globally, are preterm delivery (29 percent), birth asphyxia (23 percent), and severe infections (30 percent). Therefore, a variety of infant warming devices have been developed to protect newborns from dangerous hypothermia, neonatal resuscitation devices such as suction, bag and mask systems to help babies breathe, phototherapy systems to treat newborn hyperbilirubinemia, and mechanical ventilation assist systems to help newborns with breathing difficulties, e.g., due to pneumonia. These devices are designed to be used in rugged circumstances, in resource-limited environments, often without electricity, clean water, or sophisticated possibilities of servicing and repairing devices.

Preventing and treating hypothermia

Infant warmers and incubators, which are used to prevent and treat hypothermia, or a baby becoming too cool, have received significant attention from innovators. An infant with hypothermia has a decreased chance of survival, particularly in the first week of life, as a low body temperature is associated with severe infections and other health problems. Due to their physiologic characteristics, newborns, especially those who have a low birth weight (<2.5kg) or other health problems, face increased risk of hypothermia, even in tropical climates. Hypothermia prevention is simple, and in an ideal situation, would require little technology. The most important measure is to keep newborns dry and warm immediately after delivery, even before the umbilical cord is cut. Skin-to-skin contact with the mother or other caretaker is considered the best and most natural method to keep newborns warm, and it does not rely on any commodity. Further, keeping the mother and newborn together promotes their bonding and facilitates early initiation of breastfeeding. Breastfeeding should start as soon as possible after delivery to provide the infant with carbohydrates, produce body heat, and prevent hypoglycemia. However, in reality, skin-to-skin contact is often not practiced at a large scale. Therefore, there is a need for infant warming devices for adequate prevention of hypothermia. One promising device is the Embrace, an infant warmer currently sold in India at a fraction of the price of existing solutions, which functions without a continuous supply of electricity. It resembles a miniature sleeping bag and incorporates a phase change material, which keeps a constant temperature for up to six hours to adequately
warm the newborn.

It is critical for providers and parents to be able to identify the signs of hypothermia. Standard temperature measurement tools such as digital rectal, axillary, or tympanicthermometers may be too expensive and too hard to read for non-trained providers in most resource-poor settings. An example of a device that can be used to detect hypothermia is the ThermospotTM. This device indicates whether the newborn has hypothermia via a simple stick-on liquid crystal indicator which changes its color to alert even non-literate care-givers or parents when a certain threshold of skin temperature is passed, indicating that an infant suffers from hypothermia and should seek treatment immediately.

Assisting babies to take their first breaths

Birth asphyxia, one of the major causes of newborn mortality, accounts for one in four newborn deaths. The Program for Appropriate Technologies in Health (PATH), a large NGO supporting technology solutions for maternal and child health, compiled an inventory on low-cost devices and found that appropriate and relatively cheap solutions do exist. However, they are not widely available to those who need them at the time and place of delivery. Culturally adapted and accepted low-cost bag and mask resuscitators, as well as suction devices, are being used by the Helping Babies Breathe (HBB) initiative. HBB is an evidence-based educational program designed to educate potential caregivers on neonatal resuscitation techniques in resource-limited areas. The HBB initiative is led by the American Academy of Pediatrics in collaboration with the World Health Organization, USAID, Save the Children's Saving Newborn Lives, and a number of other global health organizations.

Reliable devices designed to monitor blood oxygen content, such as pulse oximeters, are usually very expensive and rarely available in the developing world. Those devices are crucial for monitoring critically ill newborns with pneumonia, birth asphyxia and other newborn pulmonary conditions. Pulse oximeters are also useful to screen apparently healthy newborns for congenital heart disease and instrumental to ensure a patient's safety during surgical procedures. New devices, such as the Lifebox pulse oximeters, are designed specifically for health facilities in resource-poor settings. They are robust, low cost and powered on a rechargeable battery, which is favorable in settings where electricity is not available. The Lifebox has been distributed all over the world to places including Tonga, Ecuador, Tanzania, Rwanda, and South Sudan. This device has also been deployed to every operating room in Sierra Leone. Yet, while there are several iterations of pulse oximeters in development, their use is still very limited in resource-poor settings.

Using light therapy to treat hyperbilirubinemia

Worldwide, there is a lack of data that quantifies the number of deaths or disability attributable to newborn hyperbilirubinemia, an accumulation of bilirubin that exceeds safe limits which can result in neurologic disability and even death. While most babies have some degree of jaundice, newborns who are demonstrating signs of excessive hyperbilirubinemia need to have their blood bilirubin concentrations measured. Severe hyperbilirubinemia needs to be treated promptly with a defined dose of blue light therapy, a relatively straightforward therapy. This form of therapy, however, remains out of reach for the vast majority of affected newborns. Among the promising interventions that could change this are a low-cost Iranian home phototherapy system, the Brilliance jaundice treatment device, which was developed by Design Revolution in the U.S. In addition, a Vietnamese company has developed a phototherapy system, which uses LED panels. A few of these devices can be held on a mother's lap, which has dual benefits, to promote breastfeeding while allowing the infant to continue receiving phototherapy treatment.

Diagnosing and treating sepsis/Infection in newborns

Diagnosing serious infections in settings where there is no laboratory available is an enormous global challenge. Even newborns with severe, life-threatening infections rarely display specific signs or symptoms. Though recently a subject of a great deal of research, there is no adequate tool currently available to detect infections among sick newborns or to differentiate those with a viral infection versus a bacterial infection, without laboratory data. In the near future, we anticipate that several teams of researchers will develop point of care tests that can make this determination cost efficient and outside the lab.

While it is important that newborns with severe bacterial infections are promptly treated with the right antibiotics, inappropriate use of antibiotics in newborns may promote antibiotic resistance. Efforts are now focusing on recognition of danger signs in sick newborns through the use of community-based health workers, who evaluate clinical symptoms and refer those infants who require more intense treatment to receive appropriate care. In addition, low-cost interventions can prevent infections before they can occur, e.g., by cleaning the infant's cord with a chlorhexidine solution. Large state-of-the-art trials in Nepal and Bangladesh have shown that cleansing a neonate's umbilical cord with chlorhexidine solution can save the lives of newborns.

Barriers to rapid Uptake of simple innovations

To support and potentially save the lives of babies, many barriers regarding the access to life-saving innovations need to first be identified and overcome. The most effective and efficient newborn care device is worthless unless it is ready and available when they are needed, at the time and place of birth.

However, program planners, clinicians and other key decision-makers are often unaware of existing devices and other innovations. Even when decision-makers are aware of a new technology, it may be impossible or extremely time-intensive to arrange for delivery and purchase small quantities for pilot testing. In the case of new technologies, it may take years to pilot test a device, have it evaluated and placed on the essential health technology lists. Few resource-limited settings have an efficient system of health technology assessment in place and often lack means of prioritizing one kind of a device over another. A classic example of this would be the priority placed on high-powered MRIs for elites instead of an equity-sensitive deployment of oximeters, ambu-bags and warmers to the lower and mid-level health facilities.

These are critical gaps that Maternova seeks to address. This organization, by researching, tracking and making publicly available all of the technologies in newborn and maternal health, aims to avoid duplication of effort and makes it easier to efficiently find novel life-saving devices. Innovative technologies can save mothers and newborns lives, if they are appropriate for use in resource-limited environments, if they effectively reach their target populations who demand them, and if they are put to use through effective distribution channels.