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Neonatal Equipment

Giving Neonates The Best Possible Start In Life

To meet the WHO SDG 3 goal to reduce neonatal mortality, GoI has launched various schemes like Navjaat Shishu Yojana and Pradhan Mantri Maatritva Vandana Yojana and has also established special neonatal treatment centers across the country.

Deaths of newborn babies remain alarmingly high globally, particularly among the world’s poorest countries. In low-income countries, the average newborn mortality rate is 27 deaths per 1000 births while in high-income ones the corresponding rate is 3 deaths per 1000 births. According to the World Health Organization, of 2.6 million infant deaths, 1 million die on the first day of birth and 1 million within 6 days of birth. Globally, 15 million babies are born preterm every year, which amounts to more than 1 in 10 babies. In India alone, 23 percent (>3.5 million) of preterm births are annually reported. Preterm birth complications account for 0.75 million deaths per year in India, which is more than one fourth of the world’s neonatal deaths. Preterm babies who are able to survive would remain immune challenged and highly prone to learning, hearing, and visual disabilities. There is a huge shortage of pediatricians for treating sick neonates and also of trained nursing staff for critical care babies. These babies are extremely vulnerable and usually die due to several birth complications, acquired infections, and damage to brain, lungs, or eyes. Such tiny patients require intensive medical care. Treating neonates is both a human and a technological challenge. Current thought in modern neonatology is directed toward giving these patients a real chance for survival by using non-invasive, developmental care methods whenever possible. This care must be constantly adapted to the baby’s changing needs.

Optimal neonatal intensive care ensures quiet, comfortable conditions, and minimizes stress. The European Foundation for the Care of Newborn Infants (EFCNI) recommends noise levels of 45 decibels in unprotected and 55 decibels in protected rooms. Protected from the influence of excess noise, the infant’s developmental prospects are greatly improved. Another factor essential for survival is the temperature. Premature neonates in particular are unable to regulate their body temperature when exposed to excessive heat or cold. Their tiny bodies must not be subjected to large variations of the surrounding temperatures. In a clinical setting (warming bed, incubator), necessary thermal regulation support needs to be provided. Specialized neonatal intensive care units (NICU) offer a perfect environment for the patients and their parents. Modern technology is combined with warm and comforting surroundings especially designed for neonatal well-being. Ventilators for neonates, special incubators as well as mobile monitoring and modern IT-solutions build the backbone of any NIC ward. Combined with intelligent planning and design, the NICU can be turned into an environment where caregivers can work effectively and parents and family can be involved in the process, helping to promote the baby’s best possible development.

However, collating diverse types of data from multiple sources and biomedical devices poses issues such as cost, processing, storage, network bandwidth, and confidentiality. Automation of NICU workflow by a robust big data infrastructure could facilitate monitoring and storage of the physiological and clinical phenotype parameters at various timeframes, and also help in clinical markers discovery process. This data collection can help in training semiskilled trained manpower and improving clinical protocols in providing care to neonates in emerging countries like ours. For achieving these goals recent innovations like iNICU (integrated NICU) that uses cloud, IoT, and data analytics based software solutions are being introduced. They act as a comprehensive integrated platform especially designed to address all current issues of NICU including tedious workflow, integration of data generated by multiple devices, automatic drug/nutrition calculator, auto-discharge summary, complete assessment sheets for all critical biological systems of newborns, digitalized prescription, laboratory reports, nursing notes, prenatal data, notifications/alerts to the doctor, parent engagement, predictive analytics, and NICU management. Solutions allow concurrent real time access of multiple infants to clinical experts, improving care time while technology improves care time, fills skill gap, and facilitates remote monitoring of rural regions by experts, early identification of disease, and reduction in neonatal mortality.

Indian market dynamics
The study, by Jayanta Bora and Nandita Saikia from Austria-based non-profit International Institute for Applied Systems Analysis, was one of the first to evaluate neonatal and under-five mortality at a district and state level in India. Almost half of the districts in India are not on track to reduce the mortality rates of newborns and meet the target set under the Sustainable Development Goals for 2030. India continues to have the world’s highest number of deaths among children under five and newborns, around 1.1 million per year. Under the WHO’s SDG 3, all countries should aim to reduce neonatal mortality to 12 deaths per 1000 live births per year, and under-five mortality to a maximum of 25. According to the Sample Registration System (SRS Bulletin September 2017) of the Registrar General of India, in the year 2016, there was an 8 percent decline in the newborn mortality rate and 90,000 fewer infants died in 2016 compared to 2015.

This decrease was recorded in the states of Bihar, Assam, Madhya Pradesh, Uttar Pradesh, Jharkhand, Chhattisgarh, Odisha, and Rajasthan. In the case of infant mortality, inequalities are seen in the states of India. In Kerala and Goa the rate is 10 per 1000, and in Bihar and Uttarakhand 44 per 1000. 35.9 percent of the total infant deaths are of babies born before time and the weight of children is lower at birth, 16.9 percent from pneumonia, 9.9 percent asphyxia and birth trauma, 7.9 percent other non-communicable diseases, 6.7 percent of diarrheal diseases, 4.6 percent are due to birth defects, and 4.2 percent due to infections. There is a huge lack of institutional health infrastructure and facilities. The condition of health services in villages is inadequate. According to NFHS-IV, only 21 percent of women get all pre-delivery services. When the child is growing in the womb, the inability to detect any problems causes a large number of deaths at birth.

Various schemes like Navjaat Shishu Yojana, Baal aur Kishoravastha Swasth Yojana, and Pradhan Mantri Maatritva Vandana Yojana have been launched by the government, and awareness is being created through television, radio, and newspapers. Special neonatal treatment and nutrition rehabilitation centers are also being opened across the country. If the government is serious to achieve the SDG target, more budget allocation will be needed for health services. A mass awareness campaign will need to be run at the grassroots level, in which volunteers, organizations, media, social workers, and students can help. Serious socio-economic-political effort is required to reduce neonatal mortality.

According to a Mordor Intelligence report, India is expected to have the largest market share in the Asia-Pacific fetal and neonatal care equipment market. The primary factors for the market growth in the country are a high incidence of preterm birth, the rise in awareness programs from government and non-profits organizations regarding neonatal care, and increasing healthcare facilities with healthcare infrastructure. In India, nearly 3.5 million babies are born preterm each year, and many children under the age of five die owing to preterm complications. Thus, the rising number of preterm complications, rising healthcare expenditure, and growing population are likely to drive the neonatal care equipment market rapidly in the country.

Global market scenario
The global fetal and neonatal care equipment market is estimated at USD 7279.5 million in 2017 and expected to witness a CAGR of 7.4 from 2018 to 2025, according to Coherent Market Insights. The rise in the preterm and low-weight births of newborns is one of the major factors for the growth of the market. With the rising number of births, a large number of complications are associated with preterm births leading to neonatal deaths. The numbers are rising steeply in the low and middle-income countries compared to the developed regions. Other major factors responsible for the growth of the market are the rise in the technological advancement in infant and maternal care products, rise in congenital and pregnancy complications due to sedentary lifestyle, and increased global awareness for prenatal and neonatal care.

Various government and non-government organizations are actively taking initiatives to provide better maternal and fetal care. Moreover, rise in number of problems during pregnancy due to high-blood pressure, diabetes, preterm labor affects the fetus. So, fetal and neonatal care devices are routinely used by gynecologist and obstetrics to examine fetal or babies’ health during labor and delivery. According to the National Institute of Health, newborn screening programs across the United States of America screen four million infants each year. This public health program detects treatable disorders in newborns, allowing treatment to begin, often before symptoms or permanent problems.

The rising cost of neonatal care with advancement in the medical devices is one of the major factors hindering the market. In the United States of America, the average cost of infants hospitalized in the NICUs is more than USD 3000 per day. In addition, the NICU patients total healthcare expenditure costs is nearly three times the cost of the patients population in NICUs. Thus, this affects a large number of the population particularly in the developing countries to opt for these services in regular use, impeding the growth of this market. Other factors affecting the market growth are stringent regulatory policies for new devices approval and limited accessibility in the developing regions.

North America is expected to account for highest market share in the global fetal and neonatal care equipment market, owing to the presence of a better reimbursement structure, development of well-equipped NICUs by hospitals. For instance, the NICU at Brigham and Women’s Hospital (BWH) is a 60-bed level III newborn intensive care unit that provides complex multidisciplinary care to more than 3000 babies each year. Moreover, Asia-Pacific is expected to witness high growth in the market. Increasing incidences of premature births, high birth rates in countries such as India and China, and increasing healthcare awareness are the factors boosting growth of the market in this region. Furthermore, neonatal equipment has been observed to have increasing demand in the middle-income countries, as birth rates in these countries are higher, and the priority for improved fetal and neonatal care is high in these countries. As a result, sales of the equipment are expected to flourish at a rapid rate.

Key players are focusing on offering clinicians, innovative tools, and devices for enhancing safety for mothers, babies, and families. For this, companies are focusing on acquisition strategy and increasing regulatory approval for the devices. For instance, in March 2018, Incereb, a Dublin-based MedTech company secured EUR 50,000 investment for neonatal devices to be used in NICUs. Moreover, Amref Health Africa and GE collaborated to strengthen the healthcare systems in Africa to reduce preventable maternal and infant mortality. Key players operating in the global market include Koninklijke Philips, GE Healthcare, Medtronic, Roche Diagnostics, Dragerwerk, Fanem, Fisher & Paykel Healthcare, Fujifilm SonoSite, Masimo, Natus Medical Incorporated, Atom Medical, Phoenix Medical Systems, CooperSurgical, and Becton, Dickinson and Company.

Vendor update
GE Healthcare. In March 2017, GE Healthcare expanded its maternal-infant care business with the acquisition of Monica Healthcare – a U.K.-based monitoring technology company. This acquisition enhances GE Healthcare’s mobile and digital offerings by providing clinicians and patients around the world with more innovative solutions for labor, delivery, and home care.

Masimo. In February 2017, Masimo received CE marking for Eve – a critical congenital heart disease (CCHD) newborn screening application, for the Rad-97 Pulse CO-Oximeter. Eve is integrated with Masimo SET measure-through motion and low perfusion pulse oximetry with a pre-ductal to post-ductal synchronization algorithm designed to reduce calculation errors and giving appropriate outcomes for the treatment of newborn lives.

Draeger. With a mission to provide every newborn with the best start to life, in August 2017, Draeger redefined neonatal care with the introduction of a new FDA-cleared IncuWarmer, Babyleo TN500. Draeger conducted extensive research to identify the optimal conditions for pre-term babies to thrive in the NICU, and designed Babyleo to provide the best setting for neonatal development – taking into account the baby’s own environment, family involvement, and clinical workflow.

Fisher & Paykel Healthcare. The company will shortly launch a new neonatal respiratory care device to the Indian market, the F&P 950 Heated Humidification system. In particular, the introduction of Thermadapt technology, in which the circuit automatically adjusts its temperature according to the baby’s current environmental condition – ambient, warmer, or incubator – is a stand out feature that makes it very easy for nurses and doctors to set up and operate. The F&P 950 complements the recent release of Optiflow Junior 2 (high flow nasal cannula) in which Fisher & Paykel have pioneered the use in neonatal and infant care in recent years.

Technological advances
Giving premature infants the best possible start in life continues to pose significant medical challenges. High-technology equipment has made a huge difference in the survival of the frailest and tiniest of premature babies.

Volume-controlled ventilation. The technical challenges apply not only to the incubators, but also to the mechanical ventilators many neonates require for survival. The lungs of premature babies are tiny and quite sensitive. Correspondingly, the amount of air that a ventilator delivers is very small – for an infant weighing around 1 kg. Air enters the lungs either by a tube placed through the mouth into the airway or, in the case of nasal ventilation, through a so-called prong, which is attached to the baby’s nose. As an alternative to classic pressure-controlled ventilation, volume-controlled ventilation is now being recommended. The ventilator uses the lowest possible pressure to deliver the necessary tidal volume. Studies have shown that this method improves both pulmonary function and survival.

Smartphone apps. The conversion of standard treatment protocols (STP) into a smartphone app provides a stepwise, evidence-based approach to management of sick neonates in an emergency room and the treatment of common conditions following initial stabilization. The apps help users in practicing rational and recommended newborn care, including calculation of IV fluid volumes and medication preparation. The apps, in addition to being user-friendly, have the advantage of easy, immediate availability as a point-of-care tool, and gives an opportunity for users to learn and practice skills related to clinical procedures and use of essential equipment. The platform for apps has changed in the last five years, with technology upgrades in both Android and iOS software. Thus the app needed to be upgraded. Recently Reaching the Every Newborn National 2020 Milestones WHO reported smartphone apps as an innovation for service delivery to disseminate best practices. Updating and adding value to previous versions should enhance coverage and utilization of this innovative tool.

Reducing alarms in the NICU. With an increasing number of complex devices being used in NICUs around the world, the alarms generated by these devices become a major burden on both patients and staff, leading to increased cardiorespiratory instability in patients and higher stress levels as well as desensitization to alarms (alarm fatigue) among staff members. The latter may result in dangerously long response times to true alarms. Now new technologies are available in the market that help to reduce alarm fatigue such as smart alarms that can reduce the number of false alarms by taking into account multiple parameters, rate of change, and signal quality; latest alarm technology that incorporates short delays; custom filters can be created to ensure that notifications are timely and meaningful without overburdening caregivers that are based on the alarm level, type, and other conditions that determine when alarms will go directly to nurses’ smartphones.

Near infrared spectroscopy. All the vital parameters of the newborn like heart rate, respiratory rate, capillary refill time, invasive or non-invasive blood pressure, saturation, and blood sugar should be monitored and recorded in the newborn case record. Near infrared spectroscopy (NIRS) is a newly emerging technology in which bed side assessment of tissue blood flow/perfusion is done including cerebral, renal, and gastro-intestinal tract in neonates having perinatal asphyxia, shock, cyanotic heart disease, or intestinal surgeries. NIRS is being used in management of neonates undergoing surgical correction for complex congenital heart disease. NIRS is also being used for monitoring cRSO2 in neonates during transition after birth, a period when the brain is vulnerable to injury and dysfunction. It is also being used in premature newborns to see the impact of prematurity and intensive care on early brain development.

MRI-compatible incubators. These are equipped with an integrated head coil and accompanied by auditory shielding, temperature and humidity regulators, a ventilation support system, and monitors specifically certified for the massive magnetic environment of the MRI. The constant environment reduces the risk of adverse events occurring during the transport and imaging of the neonate. Advantages of the MRI-compatible neonatal incubator include halving the time required for handling the infant, a reduction of total procedure time by an average of 20 minutes, and in imaging time by four minutes. Recently, neonatal MRI systems have sought to close the gap between NICU imaging requirements and the capabilities of current MRI-compatible incubators. As with other efforts to date, the modified system also attained several collateral objectives, such as ease of installation and operation in an NICU, improved visual contact and physical access to the infant, along with the use of advanced imaging techniques, ECG, and respiratory gating and triggering. One of the most important benefits consisted of the reduction of risk associated with transport of the neonate to and from the NICU.

IT to optimize NICU visitation. Tele NICU is connecting remote NICU to specialist centers through a real-time monitoring system and video link. Key equipment in the NICUs like baby warmers, incubators, patient monitors, and ventilators are connected through indigenously developed hub and Internet. Bed side crucial supporting devices stream the key vital health parameters or information through servers or cloud infrastructures to the remote centers to view the data live. Customized alert mechanism and historical trending are tracked in order to provide an alarm and relevant information to neonatologists viewing from a remote place/command center. Neonates with critical conditions like sepsis, hypothermia, and hypoxia are monitored remotely and timely interventions are made to save lives of neonates, hence reducing infant mortality.

The infant incubators and warmers in the NICU play the role of bed and provide conducive environments for critical babies and vital health parameters are measured. These devices are operated under an isolated environment and monitoring the health of the babies requires staff nurses or neonatologists to visit the bed. Tele NICU virtually bring these devices and babies to the place where the specialist neonatologist is and can monitor the babies remotely. This will have a significant impact, when these warmers are located in the remote area maternity hospitals and require immediate attention for babies by neonatologists.

Outlook
Over the past few decades, neonatal intensive care for high-risk newborn infants, including preterm infants, has developed markedly due to the commitment of individual neonatologists and neonatal healthcare workers, as well as the continuous investments by the government. Generally, outcomes of very low birth weight infants among preterm infants are regarded as a reflection of the quality of neonatal care. For the past several years, the health authorities have worked tirelessly toward the goal of resolving the shortcomings of NICU nationwide and there have been visible improvements in the survival rate of newborn infants along with preterm infants. NICU beds and equipment for neonatal are greatly being expanded across the country. For instance, JK Lone Hospital in Jaipur added 105 more beds in its NICU; public hospitals at Mumbai added 280 more ventilators in their neonatal wards; Rajiv Gandhi Municipal Hospital in Yerawada and Chandumama Sonawane Hospital in Bhavani Peth opened their newly set up NICU under PPP model with the Mukul Madhav Foundation and the Pune Municipal Corporation (PMC), with each of the NICU units having 14 beds with state-of-the-art neonatal care facilities.

Although the effects of such investment may not be immediate, change of idea for paradigm shift to improve safety and quality with societal empathy and cooperation are essential for overcoming the serious problem of neonatal mortality, and thus to prepare the country for the future. However, to make efficient neonatal care, integrated and big-picturing efforts, and supports by government are obligatory needed, which include bold investment and institutional reinforcement for developing proper medical care systems during the vulnerable perinatal period and for newborn infants, proper institutional leveling of neonatal and perinatal care centers according to the patient’s care level with legalization of qualifications including obtaining mandatory human, facility, and equipment resources.

Digital technology such as smartphone-based solutions is a relatively low-cost way of providing reliable and technically sound healthcare information and knowledge that can help improve neonatal health outcomes. The ubiquity of smartphone access now offers a platform that can be leveraged for a variety of interventions, including enhancing knowledge of healthcare providers for best neonatal healthcare practices. With artificial intelligence transforming the way we work, there is scope for the smartphone app to give feedback or debriefing to a healthcare provider during and after actual case management. Additional features which could be introduced include tracking cases, keeping logbook of trainees and healthcare providers, and linking with accountability and remuneration to healthcare providers. Healthcare analytics and artificial intelligence is the future of healthcare IT.

With critical care data aggregated and saved for future use, this will be vital information for the healthcare analytics. Prediction algorithms will power the decision making for avoiding mortality or crisis. Marking the vital data variations due to critical illness and presenting it as a case study will be the key for research development and training upcoming neonatologists. Tele NICU will help in connecting the critical care facilities and echo systems by providing the required information at the right time. The rural maternity hospitals with NICUs, remote referral hospitals without specialized neonatologists will be greatly benefited with such technology upgrade.

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