We would like to acknowledge Dr. Dharmapuri Vidyasagar for his contributions in the earlier edition of this chapter.
The first chapter in this book describes the historical origins of neonatal ventilation in the Western world. Despite rapid growth in the developed countries, neonatal intensive care units (NICUs) and high-technology care such as neonatal respiratory support have evolved more slowly in resource-limited countries since 1975. Multiple factors such as poor economy, lack of skilled personnel, lack of equipment, and failure to develop structured programs have been responsible for the delayed progress. Furthermore, countries with high neonatal and infant mortality rates have rightfully focused more on prevention of common public health issues and simple programs for resuscitation and essential care of the newborn rather than on establishing expensive NICUs with ventilator care facilities. However, in recent years, globalization has increased access to new medical knowledge and technology for many developing countries. The twenty-first century will see rapid progression of respiratory support programs in neonatal units around the world, although progress will be uneven. The Every Newborn Action Plan calls for an end to preventable newborn deaths. To accomplish this goal, some babies will need the assistance of more advanced respiratory care, including continuous positive airway pressure (CPAP) and neonatal-specific ventilators.
In this chapter we review the current status of NICUs in resource-limited countries, barriers to development of respiratory care programs, and possible strategies to overcome these barriers to develop functional respiratory care programs appropriate to the region.
Scope of the Need
High neonatal mortality rates (NMRs) and infant mortality rates (IMR) constitute major health problems in low- and middle-income countries. According to the World Bank classification system, a country with a gross national per capita income of less than US $12,746 in 2013 is considered a low- and middle-income or developing country. Globally, nearly 3 million babies die in the neonatal period (during the first 28 days of life), and 2.6 million babies are stillborn each year. Most newborn deaths occur in low- and middle-income countries. Three causes accounted for more than 80% of neonatal mortality in 2012: complications of prematurity, intrapartum-related neonatal deaths (including birth asphyxia), and neonatal infections. Complications of prematurity are the second leading cause of all deaths under 5 years of age. Newborn resuscitation programs such as Helping Babies Breathe have demonstrated a reduction in neonatal mortality. Resuscitation training in resource-limited facilities can reduce intrapartum-related neonatal death by 30% and early neonatal death by 38%. However, after newborn resuscitation, some newborns may require CPAP or assisted ventilation. An estimated 21% of babies presenting with illness in the first 6 days of life have respiratory symptoms that may require respiratory support. In low- and middle-income countries, there is a need for neonatal care programs equipped with proper respiratory equipment and trained personnel. Facilities need tools such as oxygen, resuscitation bags and masks, and possibly CPAP to provide basic respiratory support. The higher level care hospitals should have the capabilities of CPAP and mechanical ventilation. To provide CPAP and assisted ventilation, the health facilities must be staffed by well-trained medical and nursing personnel.
The information about level II and III units in resource-limited countries is scanty. As expected, these countries have the highest NMRs and IMRs and therefore have the greatest needs. For example, India, with an NMR of 29 in 1000 and 25 million births per year would require hundreds of level III and perhaps thousands of level II NICUs. It is estimated that in India, with approximately 1.2 billion people, one level III NICU with 30 beds is required for every 1 million population with additional level II health facilities. Ideally, to be effective there should be a cooperative regional perinatal program that is responsible for the coordination of clinical activities, education, resource use, quality improvement, and development of evidence-based clinical pathways for best practices.
A parallel improvement in hospital-based prenatal and neonatal care is required for further reduction in the NMR. Because respiratory compromise is common in all three important causes of neonatal mortality (prematurity, birth asphyxia, and neonatal infections), effective programs for managing respiratory distress could have a major impact on NMRs.
Major barriers to developing regional respiratory care programs in resource-limited countries include limited infrastructure and availability of equipment, properly trained staff, and quality improvement programs and the absence of coordinated systems. Health facilities in many resource-limited countries do not meet the basic needs of newborn care such as provision of warmth, a clean environment, and breast milk. Yet ironically, some of these countries are beginning to open level III units in their district hospitals. Some district-level hospitals are equipped with oxygen and suction; however, resuscitation bags and radiant warmers are often not present, and oxygen hoods are infrequently available. Even when resuscitation bags are available, there is often no system in place to clean and store them in an appropriate place. The primary health centers, each of which serves a population of 10,000 to 15,000 and provides basic maternity services, have practically no equipment. There is an urgent need to improve these deficiencies. Respiratory support is either limited to a very few hospitals or is available only in the private sector and hence not accessible to most babies.
There are several barriers to developing respiratory care services at all levels in resource-limited countries. Some of these barriers are described below.
Respiratory Care Program Barrier
There is a lack of structured respiratory care programs with quality improvement initiatives. There are essentially few or no policies or guidelines either for clinical care or for maintenance of equipment. Even if equipment is said to be available, it may not be functioning or may be locked away and unavailable.
Appropriate physical infrastructure is lacking. The hospitals do not have properly designed intensive care units for adults, much less for newborns. Even in district and teaching hospitals, the space for the management of high-risk infants is arbitrarily allocated and may lack the basic requirements of running water, a consistent supply of electricity, and a controlled environment. There are problems maintaining a consistent supply of oxygen and/or compressed air. Many units depend on cylinders for air and oxygen. Maintenance of equipment is irregular at the best hospitals and nonexistent in most units.
Skilled Health Care Personnel
There is a shortage of skilled medical and nursing staff in resource-limited countries. These limitations put constraints on patient care. Even if nurses are trained, they are variably assigned to different units so that there is a constant turnover of staff. Physicians have to assume many responsibilities for which they are ill equipped, such as manipulations of the ventilator. In the absence of trained neonatologists, care is performed by general pediatricians who usually are not familiar with ventilator management. A few are able to manage mild cases of respiratory distress with oxygen. For the most part, physicians are not trained to provide CPAP, endotracheal tube placement, or ventilation. Most NICUs are managed by general pediatricians who have a special interest or have had some previous experience in assisted ventilation. Nurses and pediatricians in most resource-limited countries do not have degrees of training and proficiency in managing neonatal respiratory support similar to those of workers in developed countries.
Developing countries also face shortages of doctors and nursing staff because of widespread emigration of skilled health care personnel to the developed world, known euphemistically as the “Brain Drain.” Innovative programs are needed to retain skilled workers in resource-limited countries.
Ancillary services such as blood gas machines, portable radiology machines, microchemistry laboratories, oxygen saturation monitors, and heart rate monitors are not available in most of the NICUs.
During the last quarter of the twentieth century, many resource-limited countries successfully developed a few model NICUs with outcomes comparable to those of the developed world. These unique programs were developed mainly through the efforts of committed individuals and concerted efforts of professional organizations. NICU development was complemented by the phenomenon of “globalization and diffusion of technology” during the past three decades. It is recognized that widespread implementation of low-cost, robust respiratory technologies (e.g., oxygen concentrators, oxygen saturation monitoring, bubble CPAP) could save the lives of many newborns admitted to facilities in resource-limited nations. The evolution of neonatal intensive care and specifically ventilatory care is described below for a few select regions of the world.
The neonatal intensive care program in China was established by the Ministry of Health and the United Nations Children’s Fund in the early 1980s. Since then the infant mortality and morbidity rates in China have declined steadily. However, the incidence of low-birth-weight (LBW) infants is reported to have increased from 4% to 6% in the 1990s to 10.2% in 2002. LBW infants constitute most of the NICU admissions at all medical centers. Continuing advances in neonatal intensive care, especially the introduction of mechanical ventilation and surfactant administration, have increased the survival of preterm infants in China.
The Neonatal Resuscitation Program was introduced into China in the 1990s, decreasing delivery room deaths and the incidence of Apgar ≤7 at 1 minute. Babies requiring further care are usually transferred to level III hospitals to receive additional treatment.
The levels of care in the NICUs differ across the country. Nasal CPAP is most often used earlier in babies with respiratory distress syndrome (RDS) or spontaneously breathing premature infants when oxygen requirements are less than 50%. CPAP is also used for weaning infants from ventilators and in preterm babies with recurrent apnea. Limited data are available regarding the best ways to use CPAP in the country. It is now common practice to intubate and ventilate as an elective procedure in the early stage of most forms of severe neonatal respiratory disease. Synchronized intermittent mandatory ventilation is one of the most widely used modalities of respiratory support. Li and Wei showed that the use of pulmonary mechanics measurement was helpful in guiding the use of ventilator adjustment and decreased ventilator-associated lung injury in neonatal RDS. High-frequency oscillatory ventilation (HFOV) and high-frequency jet ventilation are used in only a few units when infants with respiratory failure do not respond to conventional ventilation. A study from China showed that, compared with conventional mechanical ventilation, HFOV was associated with lower mortality (2.3% vs 7.3%), bronchopulmonary dysplasia (BPD) (7.5% vs 16.9%), and BPD or death (9.6% vs 29.3%) in preterm infants of <32 weeks.
In a survey of 23 NICUs done in 2004-2005, with a total of 13,070 admissions, 1722 (13%) babies were treated with mechanical ventilation for respiratory failure, with the predominant diagnoses of RDS, pneumonia/sepsis, and meconium aspiration syndrome (MAS). The mortality rate of ventilated infants was 32%. The mean length of hospital stay for all infants treated with ventilation was 19.2 ± 14.6 days. The median length of stay for survivors was 70 days. Mean hospital cost per survivor was 14,966 ± 13,465 yuans (equivalent to approximately US$2138). An updated survey in 2010 revealed that the incidence of neonatal respiratory failure in NICUs had increased from 13% to 19.7%, and the overall mortality had decreased from 32% to 24.7%; the overall mortality for MAS fell from 39.3% to 29.7%; and the overall mortality for pneumonia/sepsis decreased from 33.8% to 28.6%.
With increasing use of ventilatory support in premature infants and increasing survival, the incidence of chronic lung disease (CLD) in China is increasing. In view of increasing CLD and concerns of pulmonary oxygen toxicity, the government of China has developed guidelines for oxygen therapy in the neonatal period. These guidelines call for strict indications for the use of oxygen and using the lowest supplemental FiO 2 to maintain oxygenation saturation between 90% and 95% with pulse oximetry.
The development of neonatal intensive care in India has been slow because of constraints such as availability of required technology and skilled personnel. Economic constraints prevent the development of expensive high-technology NICUs in the country. Faced with high NMR and IMR, policy makers thought it prudent to invest in improving overall health rather than in high-technology medicine. The concept of providing good level II care to premature and LBW infants was well in place as early as the 1950s. Respiratory support was limited to providing oxygen in addition to providing thermal care and intravenous (IV) fluids. It was not until the mid-1970s and early 1980s that NICUs in India began to provide ventilator support.
A major impetus to the nationwide growth of neonatal intensive care and therefore neonatal ventilation in India came from the professional organization, National Neonatology Forum (NNF), which was established in 1980. The NNF focused on developing policy guidelines and standardization of care (bedside monitoring, equipment use, evidence-based guidelines, and assisted ventilation), designation of levels of care, and an accreditation process for neonatal and perinatal care in the country. The organization also placed a great emphasis on the education and training of pediatricians and nurses. Surveys by the NNF demonstrated a gradual improvement in the availability of equipment and staffs.
Since 1995, several neonatal units providing complete care with ventilatory capabilities have evolved, primarily in private settings. The results in these units managed by highly qualified staffs are comparable to those of Western units for almost all birth-weight groups ( Table 38-1 ). In a survey of 70 neonatal units in India, there was significant progress in infrastructure and availability of equipment and trained workers, supporting staff, and services. The units had mechanical ventilators but very few had blood gas machines, in-house X-ray facilities, invasive blood pressure monitoring, and ophthalmology support. High-frequency ventilation to provide respiratory support is limited to a few centers.
|Birth Weight (g)||1995||2010||2014|
|n = 1672 (%)||n = 2191 (%)||n = 2631 (%)|
|4000 or more||100.0||100.0||100.0|
The progress in neonatal ventilation can be indirectly assessed by the number of ventilators purchased in the country. The data provided by Marketstrat, Inc., a company that analyzes such global information, shows that the number of ventilator purchases in India has been increasing at a steady rate of 3% to 4% per year. This is somewhat higher than the rate of ventilator growth projected in China (2%-3%/year). Based on the large numbers of births and high rates of birth asphyxia, LBW, and prematurely born infants (estimated 7% of births or 1.75 million per year), there is a greater need for further development of NICUs across the country. With nearly 548 special care newborn units in district hospitals, 1810 newborn stabilization units at subdistrict hospitals, and 0.9 million Accredited Social Health Activist workers in the community, the country is gearing up to face the enormous task of providing health care to 26 million neonates born each year. Low-cost and innovative methods to provide respiratory support (such as bubble CPAP) short of mechanical ventilation at subdistrict and district hospitals are also being initiated.
Some privately run NICUs in India meet all of the international standards in space, equipment, and skilled medical and nursing staff. A few hospitals in developing countries have been accredited by The Joint Commission. The high cost of care in these hospitals precludes access by the majority of the country’s population.
Bhutta et al. reported an encouraging experience in Pakistan. The provision of ventilatory support to infants with RDS in Pakistan resulted in increased survival specifically in infants weighing more than 1000 g. The authors concluded that respiratory care can be developed in selected hospitals to successfully manage neonates with RDS. With the establishment of NICUs, Ho and Chang from Malaysia reported that the survival of all very low birth-weight (VLBW) infants in one NICU improved from 69% in 1993 to 81% in 2003. Among ventilated VLBW babies, survival improved from 53% to 93%. Interestingly, there was no significant improvement in mortality of nonventilated babies, suggesting that neonatal ventilation significantly contributed to increased survival among VLBW infants in this unit.
Latin America has high NMRs and IMRs with significant disparities among the countries. In some Latin American countries (e.g., Cuba, Chile, Costa Rica, Jamaica), the NMR ranges from 3 to 11 in 1000 births, whereas other countries (Mexico) report IMRs as high as 25 in 1000 births. Similar to other resource-limited countries in the world, the major cause of neonatal mortality is respiratory diseases. Most newborns who die do so within days of birth, mostly from inadequate resuscitation at birth and lack of respiratory support after admission to the ward. The majority of these deaths could be prevented with development of facilities that provide adequate resuscitation and respiratory support. In 1980, Ventura-Junca et al. showed the effectiveness of NICU care in reducing neonatal mortality in Chile. However, such facilities are available mainly in private hospitals. In a multicenter study from South American NICUs, infants randomized to bubble CPAP had significant reduction in need for mechanical ventilation and surfactant therapy compared to hood oxygen alone.
Malawi has the highest rate of preterm births in the world: 18.1% of all newborns in Malawi are born prematurely with a not surprisingly high NMR. The current standard of care in Malawi for babies with any type of respiratory difficulty is nasal oxygen therapy. However, the use of bubble CPAP to treat babies with RDS resulted in 27% absolute improvement in survival to discharge. Only 24% of neonates with RDS treated with nasal oxygen survived to discharge compared to 65% receiving bubble CPAP. Introduction of CPAP in Fiji was associated with a 50% reduction in the need for mechanical ventilation, thereby demonstrating that CPAP for resource-limited settings may be a viable and relatively inexpensive option to decrease neonatal mortality. Moreover, the staff nurses were able to safely apply bubble CPAP after 1 to 2 months of training.
On the basis of reported national NMR, Paul and Singh proposed a stepwise approach to neonatal health care strategies in developing countries. For countries with neonatal mortality of more than 25 per 1000 live births, the focus should be on community-based care. Once the mortality is less than 25 per 1000 live births, perinatal care should be provided by a network of facilities close to the community managed by midwives, nurses, and physicians. At this stage widespread implementation of low-cost, robust respiratory technologies (e.g., oxygen concentrators, oxygen saturation monitoring, and bubble CPAP) could save the lives of many newborn infants admitted to the facilities. The projected needs for respiratory support to save lives in resource-limited countries are presented in Figure 38-1 .
Establishing Respiratory Care Programs
There is a great interest among pediatricians and neonatologists in resource-limited countries to establish respiratory care programs for critically ill newborns and save many more babies. However, establishing a respiratory care unit requires a major commitment of funds, resources, personnel, and time that would have to be diverted away from other health care needs. A one-time capital investment for the purchase of equipment would seem reasonable. However, it should be understood that establishing a respiratory care program requires more than equipment, including development of clinical care pathways, maintenance of the equipment, ability to obtain replacement parts, ongoing professional development programs for all levels of providers, full-fledged ancillary support systems (e.g., laboratory, radiology), and a regional system of referral that promotes centralized ventilator care. To be cost-effective, regional centers that serve large populations should develop assisted ventilation support systems. A regionalized perinatal center requires a well-developed and efficient transport system for in utero transport as well as newborn emergency transport.
However, the introduction of CPAP/bubble CPAP may be appropriate for level II units in these settings. Fernandez and Mondkar suggest establishing one tertiary care NICU providing assisted ventilation per 1 million population in resource-limited countries. To establish a strong respiratory care program, the following components are necessary ( Fig. 38-2 ):
Leadership and partnership
Evaluation and monitoring
Leadership and Partnership
In the past the leadership has consisted of a small group of technical experts or champions. There is a need for engagement of active stakeholders at all levels of government. They can advocate and set a course of action that is supported at national and local levels. In addition, families are an important partner who can assist with taking care of their baby, recognizing that respiratory care saves lives, and publicly advocating for the provision of these services. Governments respond to increases in demand, and it will be easier to develop regionalized services with families as partners.
Implementation of respiratory services needs adequate infrastructure, resources (equipment and human), clinical care monitoring systems, and ongoing quality improvement programs. Policies have to be developed based on local evidence. Proper infrastructure should be made available depending on the size of the unit. In addition, medications such as antibiotics and surfactant should be readily available.
It is the ultimate goal of pediatricians and neonatologists around the world to be able to establish an NICU providing ventilator care. To be successful and cost-effective, the planners must consider certain criteria before attempting to establish a neonatal respiratory care program. Box 38-1 lists some basic requirements for establishing a respiratory care program in any hospital. It describes the operational needs, costs, and criteria for choosing a ventilator. In addition to the provision of basic needs such as space and an uninterrupted supply of power, water, and gases, the availability of appropriate equipment and skilled staff is critical to the successful operation of any respiratory care program.