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Y. Kapotth, M.B. B.CH. B.A.O., Ph.D.

Clinical Director, Morehouse School of Medicine

However, if we accept that science consists of a body of knowledge, the final adjudicator of which is observation of the natural world, and if we accept that our observations are limited by the resources available, then there is no practical difference between phenomena that we cannot observe and those that do not exist ("For whereof we cannot speak, thereof we must be silent")7. What are we then to make of all the animal data generated in modelling a human effect that may not even exist How many resources were "wasted" on such investigations and how many animals were needlessly subjected to "meaningless" studies The key redeeming fact about such studies is a counterintuitive utility even to that which does not translate. At first consideration, it seems that this notion is not possible; if the phenomenon being "modelled" does not exist, then is one modelling anything at all Of course, the answer is "yes", just because scientists may not know what they are modelling does not mean they are not modelling something useful. In one of the best descriptions of how research really works, Peter Medawar, the immunologist and Nobel laureate, detailed how experiments in tumour transplantation in mice examined a biology that does not occur in humans8. However, far from modelling nothing, they were inadvertently modelling tissue transplantation, and, eventually, the biology of histocompatibility and immune recognition, in general. When Bruce Beutler, another immunologist and Nobel laureate, and his colleagues became interested in the effects of endotoxin in mice, it was already well understood that "septic mice" have a drop in temperature instead of a fever, which seems to be a poor model for human biology. However, it was precisely this "broken" response that allowed him to identify a specific toll-like receptor as the murine, and then human, response element to endotoxin9. Do they model effects that really occur in humans in general, but too infrequently to be observed Perhaps we are modelling something unrelated to human biology at all, although this seems unlikely, given the close evolutionary relationships among mammals. Still, it remains possible that we are studying biology relevant only to our livestock, our companion animals, and the vermin in our sewers. Nevertheless, although we do not yet understand the utility of this knowledge, the history of science teaches that the effort is not wasted effort as long as the experiments are properly designed, rigorously performed, and accurately reported. The data are what the data are, but their interpretation, meaning, and importance will evolve over time in the context of our ever-expanding base of scientific knowledge. The detailed investigations of humans, and the simultaneous modelling studies in vitro, in animals, and in human volunteers, have generated a new body of knowledge, the greatest utility of which is likely not yet clear. However, what is clear is that we not only kept a watchful eye on potential problems, but also did not rush impetuously into making reflexive changes, without careful scrutiny and study. The field is also indebted to the support from government, public sector, and industry sources to allow such studies to be performed. At the end of the day, we understand much more now than we did when we started, and we are more knowledgeable about what is best for our patients, and how best to save human lives, while doing the least harm. What has just occurred in the field of blood storage biology is exactly how the scientific process is supposed to work. However, the convenience of having red blood cell inventories was accompanied by a disadvantage. Red cells undergo numerous physical and metabolic changes during cold storage, the "storage lesion(s)". Whereas controlled clinical trials have not confirmed the clinical importance of such changes, ethical and operational issues have prevented careful study of the oldest stored red blood cells. Suggestions of toxicity from meta-analyses motivated us to develop pre-clinical canine models to compare the freshest vs the oldest red blood cells. Our model of canine pneumonia with red blood cell transfusion indicated that the oldest red blood cells increased mortality, that the severity of pneumonia is important, but that the dose of transfused red blood cells is not. Washing the oldest red blood cells reduces mortality by removing senescent cells and remnants, whereas washing fresher cells increases mortality by damaging the red blood cell membrane. An opposite effect was found in a model of haemorrhagic shock with reperfusion injury. Physiological studies indicate that release of iron from old cells is a primary mechanism of toxicity during infection, whereas scavenging of cellfree haemoglobin may be beneficial during reperfusion injury. Intravenous iron appears to have toxicity equivalent to old red blood cells in the pneumonia model, suggesting that intravenous iron and old red blood cells should be administered with caution to infected patients.

Infants with increased energy needs, history of postnatal growth restriction, or feeding difficulties may continue on a higher caloric density feeding (24 kcal/oz). Although some studies have demonstrated improved growth rates in infants fed a nutrient-enriched formula after hospital discharge there is insufficient evidence to support routine use for all preterm infants (11-15). Factors to consider in feeding choices for the preterm infant include individual nutrient needs, tolerance, parental choice, cost and availability. Factors such as 168 Nutrition Interventions for Children With Special Health Care Needs Section 3 - Condition-Specific Nutrition Interventions immature maintenance of physiological stability, disorganized suck-swallowbreathing, decreased strength and endurance, cardiorespiratory compromise, and neurodevelopmental complications may contribute to alterations in feeding behavior and ultimately feeding success (16,17). Evaluation of preterm infants with growth concerns and/or reports of feeding difficulties should include a careful history and description of feeding behaviors and observation. In observing a feeding, attention should be given to document control, organization, coordination of suck-swallow-breathing, length of time to consume adequate volume, evidence of distress, signs of choking or changes in respiratory status. Infants who demonstrate evidence of feeding difficulties should be referred to the appropriate disciplines for further evaluation and treatment. Nutrient Needs the nutrient needs of preterm infants after hospital discharge and throughout the first year have not been clearly established. Common practice is to view the nutrient needs of the preterm infant to be the same as the term infant when the preterm infant achieves a weight of 2. Infants fed a nutrient-enriched formula after discharge show improvements in growth and mineral status. Some preterm infants may continue to be at risk for inadequate bone mineralization after discharge. These infants may need higher mineral intake and monitoring after hospitalization. Currently there are no standardized practices to treat these infants and a variety of strategies have been used without clear identification of an optimal approach (13). These infants may continue to receive supplemental bottles of formula or breast milk until the transition to total breastfeeding is complete. Soy formulas are not recommended for preterm infants, particularly those at risk for osteopenia, secondary to decreased bioavailability of calcium and phosphorus (13). Nutrition Interventions for Children With Special Health Care Needs 169 Chapter 15 - Nutrition Interventions for Premature Infant After Discharge Preterm infants often demonstrate adequate weight gain when consuming 110130 kcal/kg/day. Factors that alter energy needs, absorption, or utilization in infants will also impact the energy requirements of preterm infants. Preterm infant formula and human milk fortifiers are designed to meet the increased vitamin and mineral needs of the preterm infant taking smaller volumes than the term infant consumes. Continuation of the preterm infant formula and human milk fortifiers in infants who weigh more than 2. Case reports of hypervitaminosis D suggest that these products should be discontinued when the infant is exceeding the recommend intakes for fat-soluble vitamins. This may be provided as an iron supplement or with the appropriate volume of iron-fortified formula. The remainder of this chapter presents guidelines for nutrition assessment, intervention, and evaluation/outcome after discharge from the hospital for children who are born prematurely. Nutrition Interventions for Children With Special Health Care Needs If feeding difficulties and/or growth concerns, but fluid intake is adequate, consider increasing energy density of formula. Section 3 - Condition-Specific Nutrition Interventions Assess adequacy of formula volume for energy needs. If on non-standard formula, vitamin/ mineral intake is within recommendations for age and size. For infants with history of growth or other nutrient deficiencies, consider selection of transitional foods that will meet specific needs of infant. Emerging developmental sequelae in the "normal" extremely low birth weight infant.

Pseudo-competition quickly gave way to a monopoly, or at best a cozy duopoly in access. Some would like to extend it, lock, stock and barrel to the 21st century digital network. The magnitude of the difference between the digital communications space and other infrastructure networks is stunning. The increase in the diversity of traffic was also orders of magnitude greater than in the other network infrastructure industries as well. The command and control regulation rests on the assumption of delegation of authority from a passive public to an expert agency through institutions of representative democracy. In light of the dramatic increase in communications and empowerment at the edge, the traditional approach to democratic participation has become stale. The Internet protocols and the development of Wi-Fi are remarkable communications systems based on brutally simple obligations of interconnection and integration that are open to all on a nondiscriminatory basis and supported by voluntary standards, managed by multi-stakeholder processes that promote 83 interoperability. A key spark is provided by a regulatory decision of guarantee access, while a backstop of the threat of further governmental oversight ensures that access is available. In both cases, the government had an important role in creating the environment in which an entirely new approach to communications could thrive. This is a space that lies between the market and the state in the sense that the abuse of power by dominant communications companies and government regulators was held in check. The voluntary action of the developers of the new communications protocol to fill the space opened by government action was a key ingredient for success. They introduce the possibility for innovation at the edge of the network as a primary driver of economic activity. Functionalities that were monopolized by the network operator or, more importantly, never dreamed of by them, become possible. It repeatedly complained that services and communications by innovators should be stopped. The private sector concluded, to its credit, that a common communications protocol would expand the market and the best approach was to create voluntary institutions to adopt and defend those standards. Had they not done so, there is a good chance that the government would have stepped in to ensure interoperability, with 84 rules that would have been significantly less friendly to innovation, entrepreneurship, and consumers. For three decades encompassing the birth, childhood and adolescence of the digital communications revolution, Internet traffic flowed freely over the telecommunications network (free as in speech, not as in beer) under the Computer Inquiries to devices that were made possible by the Carter phone decision. The state used its power to create a space that was free from the worst instincts of both the market and the state, and the private actors who wanted to enter that space realized that they needed to regulate themselves in a manner consistent with the principle of nondiscrimination, which they equated with interoperability. They could have filled the space opened by the Cable Modem and Wireline Broadband Orders with a vigorous voluntary process to demonstrate a commitment to the four freedoms. Forced to operate networks in an open access manner, they make the most of it, but they do not create such networks. Open spaces like the Internet and Wi-Fi protocols are the meat and potatoes of new entrants and entrepreneurs; but anathema to entrenched network incumbents. This approach has been embraced broadly by the Internet community and important policymakers. We emphasized that, in certain cases, public support and investment may be needed to ensure the greatest practical availability of these networks in our countries, in particular in rural and remote areas, and that such public intervention should support market competition and promote private investment initiatives. Users should have the ability to access and generate lawful content and run applications of their choice. Governments may be able to achieve certain policy goals through flexible, adaptive means by encouraging, facilitating and supporting the development of codes of conduct that are supported by effective accountability mechanisms. Such co-operative efforts should be balanced and consistent with the applicable legal framework and where those co-operative efforts are not forthcoming, other policy options consistent with these principles should be considered in consultation with relevant stakeholders. Current privacy challenges are likely to become more acute as the economy and society depends more heavily on broadened and innovative uses of personal information that can be more easily gathered, stored, and analysed. Cross-border enforcement co-operation will further protect privacy and promote innovation. Low barriers to entry enabled by the open platform nature of the Internet environment have been crucial to online creativity and innovation. It is important in this regard that governments, industry and civil society work together to foster respect for the law and protect fundamental rights.

Officers can record exact response activities in real time and either transmit to the central surveillance system or upload when connectivity is available. A landscaping of currently available mobile technologies and a roadmap for mobile solutions for malaria elimination surveillance systems was commissioned by the Bill and Melinda Gates Foundation and is available at vitalwave. In elimination settings, the system ideally should include all cases in a geographic area including public, private sector, and community level data. Passive surveillance does not generally capture cases and deaths that occur outside of a health care setting, and thus might not provide a complete picture of malaria burden. As programs approach elimination, accounting for deaths and confirming malaria infection will improve as all malaria cases are diagnostically confirmed and health information systems are strengthened. Furthermore, malaria deaths should become increasingly rare in elimination settings. Active surveillance: Active surveillance includes efforts to seek out additional cases of a specific disease and can take several forms. It can include community health workers or health workers visiting villages and going door to door looking for people with signs and symptoms of malaria or testing all residents regardless of symptoms. Active surveillance is very resource- and time-intensive and is generally not considered until countries have a strong passive surveillance system and reach the elimination phase, when cases are few and health system capacity and resources allow. The effectiveness of active case detection in reducing disease burden remains unclear and such strategies should be carefully considered before they are implemented. Further action is taken within seven days which often includes reactive case finding in a predefined radius around the identified case where the patient lives or works and treatment of additional confirmed cases. Most countries targeting malaria elimination conduct some sort of reactive case detection activities. However, countries vary greatly in what triggers response measures, what diagnostic tests, if any, are used to identify additional cases and infections, whether testing is performed on asymptomatic persons or only symptomatic, the targeted radii, and the additional vector control and community education activities conducted in response. Countries use a wide range of response radii from the index household to up to 3km, often dictated by operational feasibility. Increasing evidence suggests that if local transmission is occurring, the likelihood of finding additional cases is highest in the index household and decreases rapidly beyond 200m from the index household. Determining the optimal radius for the area for case-finding activities should also be balanced by what is operationally feasible in the particular setting and by factors, such as housing density and topography. With transitions to malaria elimination, communities will experience fewer and fewer cases of malaria resulting in a decrease in perceived risk; however, the severity of malaria cases might increase. For example, establishing or reinforcing net use in fixed or sedentary communities may function differently than in smaller, mobile, migrant and vulnerable populations. In these settings, monitoring shifts in human attitudes, perceptions and behaviors will be important. To better understand behavioral influences and barriers in these settings, formative assessments using new surveys and sampling techniques may also be required. For example, as active case detection is employed in low, very low and zero transmission areas, behavioral components could be incorporated into investigations to further understand and measure the uptake of the relevant behaviors as well as related behavioral factors. Refer to the Malaria Social and Behavior Change Communication Indicator Reference Guide, Second Edition, for indicators that can be adapted for elimination settings. Countries with mobile populations may wish to build off the lessons learned from experiences in the Greater Mekong Sub-Region. The collaboration consists of four Workstreams, including: 1) Country demonstration Pilots; 2) Establishing Integrated Data Systems and Platforms; 3) Scaling Next-Generation/Innovative Surveillance Systems; and 4) Accelerating Introduction of New Tools. Background After experiencing a period of unprecedented improvements in malaria control, progress recently appears to have stalled-with several countries reporting alarming increases in malaria cases, including eight countries that witnessed an estimated increase in malaria deaths of more than 20% compared with 2015. Perhaps even more concerning than the increases in cases, is the fact that neither countries nor the broader malaria community knows whether the plateauing is due to reduced effectiveness and coverage of vector control interventions, increased rainfall or increased case reporting. At both country and global levels, this massive amount of data is generally fragmented and disparate, which makes the production of insightful analytics to inform decision-making an unnecessarily time consuming process.