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newborn baby

Creating accessible platforms for innovation is essential to advancing children’s health

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newborn baby

Children’s National Hospital continues in its efforts to educate and advocate about ways to address the unique challenges facing pediatric medical device innovation, such as small market size and a lack of industry investment. In a recent commentary for IEEE Pulse, the publication of the IEEE Engineering in Medicine and Biology Society, Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National Hospital and principal investigator of the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), discussed how the FDA and children’s hospitals are stepping in to bridge critical funding gaps and build an accessible infrastructure that safely accelerates the development and commercialization of pediatric medical devices.

Kolaleh-Eskandanian

“Our goal is to provide direct funding [with] expert advising and support services to innovators of pediatric medical devices,” says Eskandanian.

“Our goal is to provide direct funding [with] expert advising and support services to innovators of pediatric medical devices,” says Eskandanian. “The notion that innovation follows investment, that really gave us the idea of competitions where if we announced a challenge and we could put grant money behind it—and open it to the entire world — then we could attract small businesses and start-up companies that could come forward and start thinking about developing a medical device more specifically for the pediatric population.”

Now in its 8th year, NCC-PDI’s “Make Your Medical Device Pitch for Kids!” competition focuses on identifying and supporting innovators that address specific unmet pediatric needs. This year’s competition focuses on innovations in pediatric devices that treat congenital heart disease (CHD), with an emphasis on electrophysiology (EP) devices such as pacemaker systems, ablation catheters, wearable monitoring devices and related technologies that address arrhythmias in children. While the last decade brought great advances in technologies that improve the care of adult arrhythmias, pediatric patients have been left behind, with only five devices approved for use in children in the same period.

To learn more about the consortium’s efforts to advance pediatric innovation, visit the NCC-PDI website.

patient meets with ED robot

New robot helps care for kids in the emergency room at Children’s National Hospital

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patient meets with ED robot

The robot, which is part of the FCC-funded COVID-19 Telehealth Program at Children’s National, is the latest innovation of the program that has rapidly evolved due to the ongoing pandemic.

Children and families who come into the emergency room at Children’s National Hospital may be surprised when their doctor comes in – in the form of a robot. Children’s National introduced a new robot to its Emergency Department (ED) for patients under evaluation for a COVID infection or being treated for other conditions. The robot, which is part of the FCC-funded COVID-19 Telehealth Program at Children’s National, is the latest innovation of the program that has rapidly evolved due to the ongoing pandemic.

“The robot can move in and out of spaces that otherwise we couldn’t get a significant number of providers in, especially with COVID-19 restrictions in place,” said  Shireen Atabaki, M.D., M.P.H., associate medical director of Telemedicine, emergency medicine physician and program director for the COVID-19 Telehealth Program at Children’s National. “This is a really exciting program and it implements innovation that we might not have been able to do without the insights we’ve gained from the pandemic.”

The robot is Wi-Fi-enabled and can be remotely controlled by the physician providing the teleconsultation to monitor patient vitals — such as heart rate, body temperature or respiration rate. This allows doctors to work virtually with their team while also having the flexibility to attend to patients faster.

“The pandemic has made us aware of the need to protect patients, families and staff from infectious diseases,” said  Alejandro Jose Lopez-Magallon, M.D., medical director of Telemedicine at Children’s National. The robot, he noted, spares clinicians from having to change their PPE, which saves time and gives them the ability to move on to the next patient while nurses and staff continue to provide bedside care.

“We have also seen that whenever a remote clinician is completely alone in the command center and can get on-screen without a mask, in a paradoxical way our patients may be more accepting of seeing a face on a screen that’s not covered with a mask and shield than a stranger using a mask in the same room,” Dr. Lopez-Magallon added.

Soon, the robot will also be used to coordinate subspecialty care — such as cardiac care — in the ED. This will provide more streamlined and expedited care for patients. Instead of leaving with a referral to set up a follow-up appointment with a specialist, patients would be able to receive the consult they need during the same appointment.

The robot is also presenting promising solutions for concerns around the number of restricted visitors. The team at Children’s National recently piloted using an iPad and other technology purchased with the FCC funds to remotely connect family members with patients.

“We downloaded the Zoom app to iPads in our ED to be able to coordinate calls between family members who can’t come in and see patients,” said Dr. Atabaki. “We are looking to implement this as a permanent solution keeping in mind how burdensome and emotionally stressful it has been for many not having the ability to be by the loved one’s side during such a challenging time.”

The FCC funds also covered the telehealth carts, tablets and other connected devices, the telehealth platform, telehealth equipment and innovative AI (augmented intelligence) to treat seriously ill COVID-19 pediatric patients.

The emergency department robot brings the robot-fleet at Children’s National up to three. The first robot was debuted in 2019 to serve children and families in the Cardiac Intensive Care Unit.

using a laser to cut PPE face shields for staff during covid-19

Multidisciplinary team develops innovative PPE that fits clinical needs during COVID-19

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using a laser to cut PPE face shields for staff during covid-19

Children’s National engineers and clinicians developed plexiglass shields for testing sites, comfortable face shields for clinical providers, affordable oversized breath shields for ophthalmology and 3D printed flip-up attachments to the safety goggles for nurses.

The Children’s National Hospital innovation working group shares a retrospective on their local experience in mobilizing resources to offer relief following the personal protective equipment (PPE) shortages at the beginning of COVID-19. Engineers and clinicians developed plexiglass shields for testing sites, comfortable face shields for clinical providers, affordable oversized breath shields for ophthalmology and 3D printed flip-up attachments to the safety goggles for nurses.

The study, published in the Surgical Innovation Journal, narrates a series of events that occurred at the beginning of the pandemic, where the increased demand for personal protective equipment (PPE) usage in healthcare personnel skyrocketed and led to a severe national shortage. Still, the multidisciplinary approach at Children’s National facilitated the response and preparedness to the emerging situation back in March of 2020, serving as a framework for the current and future challenges.

To meet the needs of one of the busiest pediatric emergency departments in the country, the researchers aimed to develop a plexiglass shield that was reliable, reusable and practical while staying pediatric-friendly. The prototype had advantages and disadvantages while administering a COVID-19 swab test in a tent.

The 2020 FDA Emergency Authorization Use (EUA) issued in April provided manufacturing guidelines to produce face shields. Given the federal support, innovators at Children’s National, in partnership with GCMI, designed a rigid and foam prototype. Both prototypes were measured by comfort, visibility, breathability, ability to perform the job, durability, stability, fit and easy assembly. The rigid prototype performed the highest in all metrics and it had few adjustments after various tests.

“While the FDA has become nimbler as evidenced by rapid issuance of EUA of the vaccines, regulatory concerns are still paramount,” Operfmann et al. write. “Having staff experienced with regulatory processes is important to introduce new regulated devices.”

In May 2020, there was also a production lag on the available oversized breath shields for ophthalmology slits, which cost between $35 and $40. To lift the burden, the researchers designed and produced in-house a cost-effective oversized breath shield for less than $9. They used a 40 W laser machine to cut through the thick clear cast acrylic while following the compatible measurements of commercial lamps. The team also distributed the breath shields to other Children’s National regional clinics.

Within the nursing staff, the main factor associated with abiding to PPE compliance is the usage of safety goggles before entering a room. But in time-sensitive situations like patients with severe COVID-19 symptoms, the equipment can be easily forgotten. To support busy shifts, researchers designed a 3D printable attachment valued at $5 for safety goggles, which are more comfortable to keep on, even during downtime. The efficacy of the flip-up attachment is yet to be determined in an upcoming trial.

“Hospitals have already begun augmenting their disaster preparation plans and ensuring they have adequate stockpiles of equipment for future events,” Opfermann et al. write.

Children’s National authors on the study include: Justin Opfermann, M.S., Anuradha Dayal, M.D., Alyssa Abo, M.D., M.B.A., Tyler Salvador, B.S., Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., Raven McLeese, R.N., and Kevin R. Cleary, Ph.D.

chest x-ray showing pacemaker

Medical device pitch competition focuses on pediatric electrophysiology devices for CHD

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chest x-ray showing pacemaker

While the last decade brought great advances in technologies that improve the care of adult arrhythmias, pediatric patients have been left behind, with only five devices approved for use in children in the same period.

Congenital heart disease (CHD) affects six out of 1,000 babies born in the U.S. each year and is often complicated by arrhythmias, a condition where the heart beats too rapidly, too slowly or irregularly due to a misfiring of the body’s electrical impulses. While the last decade brought great advances in technologies that improve the care of adult arrhythmias, pediatric patients have been left behind, with only five devices approved for use in children in the same period. As a result, pediatric specialists are often using off-label or improvised devices to treat pediatric arrhythmias, including the smallest newborns.

Recognizing this unmet need, the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), in collaboration with MedTech Innovator, is accepting applications through April 12, 2021, for its annual “Make Your Medical Device Pitch for Kids!” competition. This year’s competition focuses on innovations in pediatric devices that treat CHD, with an emphasis on electrophysiology devices such as pacemaker systems, ablation catheters, wearable monitoring devices and related technologies that address arrhythmias in children.

“NCC-PDI was created, with the support of the Food and Drug Administration (FDA), to seek out and address significant unmet needs in pediatric medical devices,” says Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. “We have learned from the experts that pediatric-specific technologies for treating arrhythmias would be a game changer in the care of their patients, so we are focusing our competition and grant awards on this opportunity.”

Kolaleh-Eskandanian

“We have learned from the experts that pediatric-specific technologies for treating arrhythmias would be a game changer in the care of their patients, so we are focusing our competition and grant awards on this opportunity,” says Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI.

Using a virtual format, semi-finalists chosen from all submissions will make their first pitch on May 12, 2021. Up to 10 finalists selected from this event earn participation in a special pediatric-focused track of the MedTech Innovator accelerator program, the largest medtech accelerator in the world, beginning in June 2021. These innovators then participate in the pediatric competition finals in September 2021 where judges will award up to $150,000 in FDA-sponsored grants to the devices selected as most impactful and commercially viable.

How significant is the need for pediatric devices to address arrhythmias? In a recent survey of members conducted by the Pediatric and Congenital Electrophysiology Society (PACES), the vast majority (96%) said they believe there is a deficiency in devices available to serve the needs of pediatric patients. Conducted with the U.S.FDA, the survey also asked respondents to identify the biggest unmet need, which physicians identified as cardiovascular implantable electronic devices that are smaller, have better battery life and have pediatric-specific algorithms. Specifically, a leadless pacemaker designed for pediatric care was consistently on the most-wanted list.

NCC-PDI is one of five members in the FDA’s Pediatric Device Consortia Grant Program created to support the development and commercialization of medical devices for children, which lags significantly behind the advancement of adult medical devices. NCC-PDI is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and the A. James Clark School of Engineering at the University of Maryland with support from partners MedTech Innovator, BioHealth Innovation and design firm Archimedic.

Eskandanian says that enhancing access to resources for pediatric innovators is also one of the aims of the Children’s National Research & Innovation Campus, a first-of-its-kind focused on pediatric health care innovation, with the first phase currently open on the former Walter Reed Army Medical Center campus in Washington, D.C. With its proximity to federal research institutions and agencies, universities, academic research centers, as well as on-site incubator Johnson and Johnson Innovation – JLABS, the campus provides a rich ecosystem of public and private partners which, like the NCC-PDI network, will help bolster pediatric innovation and commercialization.

For more information and to apply for the upcoming NCC-PDI pitch competition, visit the NCC-PDI website.

 

global connectedness concept illustration

Research partnerships and capacity building in the time of COVID-19

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global connectedness concept illustration

“COVID infection anywhere in the world is COVID infection everywhere in the world,” said John Nkengasong, M.Sc., Ph.D., director of the Africa Centers for Disease Control (Africa CDC), during his remarks on the importance of shared science, innovation and diplomacy. Leading experts in global health met virtually on November 13, 2020, to discuss updates in the COVID-19 crisis and lessons learned in Africa. Children’s National Hospital, along with the George Washington University (GW) Institute for Africa Studies and the CNRS-EpiDaPo Lab, sponsored the half-day conference that captured the interest of international attendees committed to examining how best to expand strong and enduring partnerships between U.S. and African scientists, health professionals and research institutes to meet global challenges.

Trust, transparency and communication were common themes of expert panelists that included Elizabeth Bukusi, Ph.D., M.P.H., Kenya Medical Research Institute; Maryam DeLoffre, Ph.D., GW Humanitarian Action Initiative; Peter Kilmarx, M.D., National Institutes of Health (NIH) Fogarty International Center; Enock Motavu, Ph.D., Makerere University in Uganda; Jennifer Troyer, Ph.D., Human Health and Heredity in Africa Program (H3Africa) at NIH; Désiré Tshala-Katumbay, M.D., Ph.D., National Institute of Biomedical Research in Kinshasa; Eric Vilain, M.D., Ph.D., Center for Genetic Medicine Research at Children’s National, with Institute for African Studies Director Jennifer Cooke, and Jonathan LoTempio Jr and D’Andre Spencer of Children’s National as moderators and co-conveners. Read more about the panelists.

The keynote speaker, Nkengasong, updated the group on the massive efforts in bending the COVID-19 disease curve on the African continent which at present has two million cases and 46,000 deaths. This is fewer than many other regions, and Nkengasong attributes this in part to health systems strengthening and capacity building that already occurred with past pandemics like Ebola. He stressed the importance of focusing on the “4 Ps” — population, pathogen, politics and policy — in fighting the pandemic, and the need to ensure that citizens trust their leaders and the public health measures they advance. New endeavors by the Africa CDC include the Pathogen Genomic Initiative, which will help inform research and responses to COVID-19 and other emergent disease threats, and the African COVID-19 Vaccine Development and Access Strategy, which aims to ensure widespread access, delivery and uptake of effective vaccines across Africa. Africa CDC is surging to hotspots as lockdowns ease or shift, and is empowering universities to invest in proactive and, which has helped with the active response success. “Rising tides raise all boats in the sea,” said Nkengasong. He went on to say that there is great power in coordination and cooperation, and science diplomacy and technology are critical to winning the novel coronavirus war.

In a panel on research partnerships, speakers Motavu, Tshala-Katumbay, and Vilain emphasized the global benefits of scientific collaborations in Africa. Africa contains more human genetic variation than any other region of the world, and capturing that diversity in global understanding of the human genome — which is still heavily skewed toward individuals of European ancestry — will be a major factor in global medical advances of the future. And research into relatively localized diseases can lead to breakthroughs in broader understanding on connections between climate variation, environment, nutrition and child health. “The simplistic, localized, nationalist, way of doing science is over,” said Tshala-Katumbay, “and there is no way to go back.” The discipline of science diplomacy will take time for people to grasp, he added, “but it will be crucial for the future generation of scientists to go back.”

A recurring conference theme was that collaboration between countries is crucial for development of better care. Kilmarx told the event participants that in 2019, the National Institutes of Health supported some 1,668 collaborations with African research institutions. Investments in capacity building have yielded impressive results, and today some of Africa’s foremost leaders in science research and public health have received NIH training and support, stating: “If you plant acorns over the decades, you have some mighty oaks.” Bukusi, once such NIH trainee, now is engaged in training a new generation of African researchers and U.S. researchers based in Africa and expanding research partnerships at the Kenya Medical Research Institute.

Troyer showed the successes of the Human Heredity and Health in Africa Initiative, a large consortium that supports a pan-continental network of laboratories that aims to determine disease susceptibility and drug responses. Finally, DeLoffre underscored the need for long-term investments and the value of building local capacities to respond to current crises and anticipate future challenges.

Overall, there was optimism that innovative coalitions are a long-term strength in fighting pandemics and promoting reciprocal learning that will last after the crisis. Science can be a neutral platform that, combined with diplomacy and technology, builds bridges between peoples.

Pediatric Device Innovation Symposium graphic

Real-world evidence and the impact on pediatric device innovation

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Pediatric Device Innovation Symposium graphic

The 8th Annual Pediatric Device Innovation Symposium presented by @ChildrensNatl in conjunction with @Devices4kids took place Sept. 28-30.

The 8th Annual Pediatric Device Innovation Symposium presented by Children’s National Hospital in conjunction with the National Capital Consortium for Pediatric Medical Devices (NCC-PDI) kicked off on Monday, Sept. 28, 2020 with a panel featuring three fellow members of the FDA-funded Pediatric Device Consortia (PDC) Grants Program discussing real-world evidence and the vital role that innovation and technology play in advancing healthcare for the pediatric population.

As described by the FDA, real-world evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product, derived from the analysis of patient data. RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials and observational studies (prospective and/or retrospective).

The symposium panel, “Pediatric Device Consortia Update on the Use of Real-World Evidence (RWE) for Pediatric Device Innovation” examined real-world evidence (RWE) demonstration projects from Southwest Pediatric Device Consortium, UCSF-Stanford Pediatric Device Consortium and the West Coast Consortium for Technology and Innovation in Pediatrics (CTIP). The panel was moderated by Juan Espinoza, M.D., FAAP, director of CTIP.

“Real-world evidence projects are critical to the advancement of pediatric medical device innovation,” said Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National Hospital, and principal investigator for NCC-PDI. “Bringing together our colleagues in pediatric healthcare through the symposium helps us together identify solutions that will bring medical device innovations to the market faster to benefit the children and families we all serve.”

Here are some of the key discussion points made by panelists regarding current RWE demonstration projects:

  • Emerging medical and consumer technologies are enabling the diabetes community to take great strides toward truly personalized, real-time, data-driven management.
  • “Connected” technologies such as smartphone apps, wearable devices and sensors create an ecosystem of data driven-tools that can link patients and care teams for precision management of conditions like diabetes, including predicting a hypoglycemic event.
  • RWE has an important future in treating rare diseases by using existing data and harnessing that to improve treatment among pediatric patients.
  • Through the rich data in academic healthcare systems, practitioners are better equipped to provide RWE to address important regulatory and research questions.
  • The creation of a pediatric device patient database, which provides real-time updates to clinical, device and patient-generated health data, offers several regulatory, safety and research advantages in advancing device innovation.
Kolaleh-Eskandanian

Kolaleh Eskandanian, PhD, MBA, PMP, vice president and chief innovation officer at Children’s National Hospital, and principal investigator for NCC-PDI.

The FDA currently supports RWE demonstration projects that are focused on understanding data quality, improving RWE tools and evaluating RWE approaches to study design and data analytics. Dr. Espinoza highlighted the importance of ongoing dialogue on the use of RWE as it pertains to innovations that advance pediatric healthcare across the board.

“Thank you to the NCC-PDI team for creating this opportunity for PDCs to talk about the impact of real-world evidence on pediatric medical device development and the projects we have to move that field forward,” said Dr. Espinoza, director of CTIP and principal investigator on the PDC’s RWE Demonstration Project. “These projects are intended to inform the FDA and the industry’s approach to RWE including study design, data standards, fitness for use and regulatory decision making and reproducibility. This is complicated work that involves research, IT infrastructure, clinical care and operations.”

NCC-PDI, which is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and the A. James Clark School of Engineering at the University of Maryland, is one of five members of the FDA’s Pediatric Device Consortia Grant Program. To date, NCC-PDI has mentored over 100 medical device sponsors to help advance their pediatric innovations, with seven devices having received either their FDA market clearance or CE marking.

NCC-PDI device competition

Medical device competition announces six winners to share in $250K

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Judges award grants for pediatric medical devices that address cardiovascular, NICU, and orthopaedic and spine device innovations.

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screenshot of pitch competition

“COVID-19-edition” of pediatric medical device competition announces winners

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NCC-PDI-COVID19-Edition-Competition

“COVID-19-edition” of pediatric medical device competition announces finalists

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Sixteen finalists have been selected in the “Make Your Medical Device Pitch for Kids!” special COVID-19 edition competition presented by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). Representing innovations in COVID-19-related pediatric medical devices, the finalists will compete in a virtual pitch event held on July 20,2020 where up to $250,000 in awards will be given. Winners will receive grant funding of up to $50,000.

The competition is led by NCC-PDI co-founders the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and the A. James Clark School of Engineering at the University of Maryland and powered by nonprofit accelerator and NCC-PDI member, MedTech Innovator.

This competition focuses on pediatric medical devices that support home health monitoring and telehealth, and improve sustainability, resiliency and readiness in diagnosing and treating children during a pandemic.

“As COVID -19 continues to threaten the health of families and children across the nation, we must continue to seek new and better ways to deliver quality care during a pandemic and offer technology solutions to reopen more safely,” says Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. “Competitions like this are vital to get ahead of the healthcare challenge that COVID-19 presents in the world of pediatrics. By supporting innovation, we provide critical breakthroughs that can positively impact the lives of the children and families we serve.”

Along with grant funding, one company from the competition will be selected by Johnson & Johnson Innovation – JLABS to receive a one-year residency at JLABS @ Washington, DC, which will be located on the new Children’s National Research & Innovation Campus currently under construction. In addition to the 2021 JLABS residency, the awardee will have access to the JLABS community and expert mentoring by the Johnson & Johnson family of companies.

The 16 pediatric device innovations that judges selected for the final competition include:

  • Adipomics – simple and fast, one-step COVID-19 diagnostic kit for home or school use
  • Bloom Standard (Kaaria) – wearable, AI-driven ultrasound for infant cardiac and pulmonary screening and diagnostics
  • CereVu Medical – remote COVID-19 sensor, monitor and centralized data hub that measures blood oxygen saturation, muscle aches, temperature and trouble breathing
  • Children’s Hospital of Philadelphia – a transparent reusable DIY origami facemask that reveals facial expressions & improves communication
  • Children’s National Hospital – Lab-on-a-chip device for high-throughput combination drug screening
  • Hopscotch – gamified cognitive behavioral therapy-based computer exercises to encourage kids to stay engaged and complete treatment programs
  • Medichain – cost effective, accurate COVID-19 test with results in minutes and can detect the virus in the early stage
  • Medipines – monitor device that displays critical respiratory parameters analyzed from a patient’s breathing sample
  • OtoPhoto – a smart otoscope that quickly and accurately aids diagnosis of ear infections for home telehealth use
  • OxiWear – continuous wear oxygen-monitoring device used to reduce patient insecurity
  • REALTROMINS – real time, continuously updated predictive analytics to identify impending mortality in children
  • SurgiPals – digital assistant and urine biochemical sensor to aid in outpatient care of children with COVID-19
  • TGV-Dx – a novel, phenotype-based test system for rapid selection of effective antibiotic regimen
  • VitaScope – quick, accurate infant vital signs to facilitate high-quality virtual care
  • Vitls – wearable platform for remote patient monitoring of the vitals clinicians require to assess a patient
  • X-Biomedical – rugged, portable smart ICU ventilator for pediatric and adult patients

Funding for the competition is made possible by a grant from the Food and Drug Administration (FDA) and a philanthropic gift from Mei Xu, founder of e-commerce platform Yes She May, a site dedicated to women-owned brands.

In addition to this COVID-19 special edition event, NCC-PDI recently revealed the ten finalists in its prestigious 8th annual “Make Your Medical Device Pitch for Kids!” competition. Cardiovascular, NICU, and orthopaedic and spine device innovations are the focus of the fall competition, taking place October 7, 2020 as part of the 8th Annual Symposium on Pediatric Device Innovation, presented by Children’s National and co-located with The MedTech Conference powered by AdvaMed.

pitch competition finalists

telemedicine control room

Telehealth and AI reduce cardiac arrest in the cardiac ICU

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telemedicine control room

The telehealth command center located a few steps away from the cardiac ICU at Children’s National Hospital.

The cardiac critical care team at Children’s National Hospital has developed an innovative Tele-Cardiac Critical Care model aiming to keep constant watch over the most fragile children with critical heart disease in the cardiac ICU. The system combines traditional remote monitoring and video surveillance with an artificial intelligence algorithm trained to flag early warning signs that a critically ill infant may suffer a serious event like cardiac arrest while recovering from complex cardiac surgery. This second set of eyes helps bedside teams improve patient safety and quality of care.

These high risk post-operative patients are often neonates or small infants born with the most complex and critical congenital heart diseases that require surgery or interventional cardiac catheterization in their first days or weeks of life. At these early stages after crucial cardiac surgery, these patients can decompensate dangerously fast with few outward physical symptoms.

The AI algorithm (T3) monitors miniscule changes in oxygen delivery and identifies any mismatch with a child’s oxygen needs. It also tracks and displays small changes in vital sign trends that could lead to a serious complication. The cardiac ICU command center staff then analyzes additional patient data and alerts the bedside team whenever needed.

The Tele-Cardiac Critical Care program started two years ago. In that time, the program has contributed to a significant decrease in post-operative cardiac arrest for this patient population.

“It’s easy to see how a model  like this could be adapted to other critical care scenarios, including our other intensive care units and even to adult units,” says Ricardo Munoz, M.D., chief of Cardiac Critical Care and executive director of Telehealth. It allows the physicians and nurses to keep constant watch over these fragile patients without requiring a physician to monitor every heartbeat in person for every patient at every hour of the day to maintain optimal outcomes for all of them.”

Dr. Munoz and Alejandro Lopez-Magallon, M.D., medical director of Telehealth and cardiac critical care specialist, presented data from the pilot program at the American Telemedicine Association’s virtual Annual Meeting on June 26, 2020.

Karin S. Walsh, Psy.D., and Gerard Gioia, Ph.D., in the Division of Neuropsychology pilot robotic telepresence technology to improve video visits.

Neuropsychology pilots robotic telepresence technology for telehealth

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Karin S. Walsh, Psy.D., and Gerard Gioia, Ph.D., in the Division of Neuropsychology pilot robotic telepresence technology to improve video visits.

Karin S. Walsh, Psy.D., and Gerard Gioia, Ph.D., in the Division of Neuropsychology pilot robotic telepresence technology to improve video visits.

The telehealth program at Children’s National Hospital continues to expand access to remote specialty care for families, as well as increase consultation and liaison services to hospitals and clinicians who lack specialty care services on site. The Children’s National Division of Neuropsychology has been a leader in adopting multiple telehealth services including direct-to-consumer video visits, psychotherapy video visits, provider consultations and provider training and supervision.

Telehealth as a whole has been shown to increase access to care, with video visits in particular showing greater clinical and educational impact compared to telephone communications. Despite this, one key limitation has been the immobility of technology used to capture video visits.

To solve for immobility, Karin S. Walsh, Psy.D., is leading a pilot study testing the feasibility and acceptability of telepresence robotics in the division. Robot telepresence devices provide a unique approach to video visits, allowing for extended physical mobility and presence, while expanding interactions between providers and patients, supervisors and trainees and in educational interactions. Traditional video visits demonstrate good feasibility and acceptability by patients, families and staff. This new approach aims to increase the “presence” of the provider and further improve clinical impact, educational impact and patient satisfaction.

The division will initially incorporate two robots into clinical care beginning in May 2020.  The pilot study is expected to be carried out over the next 12-18 months, which is particularly timely given the COVID-19 pandemic. The robots, from Double Robotics, offer a high-tech, secure, integrated platform in a device that is user friendly and effective for moving freely through the clinical environment.

“With the addition of the telepresence robots, we anticipate an increase in the quality of care and access for patients and families to neuropsychological specialty care,” says Dr. Walsh. “In addition, given the geographic separation of the program – faculty and trainees are spread across six different locations – the versatile technology will increase the division’s ability to include clinicians with particular expertise into clinical sessions and consultations, as well as in training programs.”

After the pilot study, the team will assess the acceptability of robotic telepresence technology and the special qualities that this modality may offer to enhance quality of care within neuropsychology and within collaborating medical teams.

2019 pitch competition

Pediatric medical device pitch competition deadline extended

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2019 pitch competition

Pediatric innovators pitch for up to $250,000 in FDA-funded grant awards.

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announced today that the application deadline for its annual “Make Your Medical Device Pitch for Kids!” competition is extended one week to Feb. 22 at midnight EST. Innovators and startup companies with devices in the pediatric cardiovascular, orthopedic and spine, or NICU sectors are invited to apply for a share of up to $250,000 in FDA-funded awards and access to a newly created NCC-PDI pediatric device accelerator program led by MedTech Innovator. Submissions are being accepted now.

Up to 30 companies will be selected for the first round of competition scheduled for March 23, 2020 at the University of Maryland, College Park. Up to 10 finalists chosen from that event will compete for up to $250,000 in grant awards in Toronto, Canada on October 4. Finalists also receive a spot in the MedTech Innovator 2020 Accelerator – Pediatric Track, which provides a customized curriculum and in-depth mentorship.  Finalists will be announced in May, 2020.

This is the ninth competition in seven years hosted by NCC-PDI, one of five FDA Pediatric Device Consortia Grant Program members supporting the development and commercialization of pediatric medical devices. NCC-PDI is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and the A. James Clark School of Engineering at the University of Maryland. Additional consortium members include accelerators Medtech Innovator, BioHealth Innovation and design firm partner Archimedic.

“This year’s competition focuses on three medical device areas of critical need for pediatric patients, so we want to give innovators as much time as possible to prepare their submissions,” said Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI . “Our goal is to support devices that will improve care for children by helping them advance on the pathway to commercialization. We have seen how this competition can provide significant momentum for pediatric innovations, so we want to encourage as much participation as possible.”

To date, NCC-PDI has mentored over 100 medical device sponsors to help advance their pediatric innovations, notes Eskandanian, with six devices having received either their FDA market clearance or CE marking. Along with the positive exposure of presenting at this competition, she notes that the success of NCC-PDI’s portfolio companies is attributed to funding, mentorship, support from partners and facilitated interactions between device innovators and potential investors.

Eskandanian notes that enhancing access to resources for pediatric innovators is one aim of the Children’s National Research & Innovation Campus, a first-of-its-kind campus focused on pediatric healthcare innovation, currently under development on the former Walter Reed Army Medical Center campus in Washington, D.C. With its proximity to federal research institutions and agencies, universities, academic research centers, as well as on site accelerator Johnson & Johnson Innovation – JLABS, the campus will create a rich ecosystem of public and private partners which, like the NCC-PDI network, will help bolster pediatric innovation and commercialization. Opening is scheduled for December 2020.

Research & Innovation Campus

Tailoring treatments to young patients

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Research & Innovation Campus

The Children’s National Research & Innovation campus will be a a one-of-a-kind pediatric research and innovation hub.

Children’s National Hospital president and CEO, Kurt Newman, M.D., recently spoke with Modern Healthcare about the soon-to-open Children’s National Research & Innovation Campus and how it will help address the lagging development of devices, medications and technologies specifically designed to help children.

You can read the full article here.

Pediatric device competition

Premier annual pediatric medical device competition now accepting submissions

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Pediatric device competition

Pediatric innovators pitch for grant awards and participation in a special accelerator program.

The official call for submissions is underway for the premiere annual pediatric medical device competition, sponsored by National Capital Consortium for Pediatric Device Innovation (NCC-PDI). The competition is led by Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital, the A. James Clark School of Engineering at the University of Maryland and non-profit accelerator MedTech Innovator. The three organizations are all an integral part of the FDA-funded NCC-PDI, which aims to facilitate the development, production and distribution of pediatric medical devices. Additional NCC-PDI members include accelerator BioHealth Innovation and design firm Archimedic.

The competition focuses on pediatric devices in three areas of critical need: cardiovascular, orthopedic and spine, and neonatal intensive care (NICU) and is now accepting applications. Contestants will pitch for a share of up to $250K in grant awards and the opportunity to participate in the MedTech Innovator 2020 Accelerator – Pediatric Track.

The first stage of competition will be held on March 23 at the University of Maryland and will include up to 30 companies selected from all submissions received. Up to 10 finalists selected from that event will move on to the “Make Your Medical Device Pitch for Kids!” finals on October 4, 2020 in Toronto, Canada. Finalists from the March qualifying round will be notified in May, 2020.

“While there is a great need for pediatric devices in many specialty areas, the development and commercialization process is very challenging because of the small market size and dynamic characteristics of the patient population,” says Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. “To provide pediatric innovators with greater support in meeting these unique challenges, we must go beyond grant funding, which is why we are collaborating with MedTech Innovator to offer an accelerator program with a pediatric track.”

To date, NCC-PDI has mentored over 100 medical device sponsors to help advance their pediatric innovations, notes Eskandanian, with six devices having received either their FDA market clearance or CE marking. She says the success of NCC-PDI’s portfolio companies is attributed to funding, mentorship, support from partners, facilitated interactions between device innovators and potential investors, and being discovered during their presentations at the signature “Make Your Medical Device Pitch for Kids!” competitions.

While advancements have been made in some pediatric specialties, there is still a critical need for novel devices in cardiovascular, orthopedic and spine, and NICU areas. On average over the past decade, only 24 percent of life-saving medical devices approved by FDA – those that go through PMA and HDE regulatory pathways – have an indication for pediatric use. Of those, most are designated for children age 12 or older. “Devices designed specifically for the younger pediatric population are vitally needed and, at this early stage of the intervention, can significantly improve developmental outcomes for a child,” Eskandanian said.

For more information and to apply for the upcoming NCC-PDI pitch competition, visit https://medtechinnovator.org/pediatricapply/.

Enhancing access to resources for pediatric innovators is also one of the aims of the Children’s National Research and Innovation Campus, a first-of-its-kind focused on pediatric healthcare innovation, currently under development on the former Walter Reed Army Medical Center campus in Washington, D.C. and opening in December, 2020. With its proximity to federal research institutions and agencies, universities, academic research centers, as well as on site accelerator Johnson and Johnson Innovation – JLABS, the campus will create a rich ecosystem of public and private partners which, like the NCC-PDI network, will help bolster pediatric innovation and commercialization.

NOTE: The deadline for submissions has been extended to February 22 at midnight EST.

Dr. Kurt Newman in front of the capitol building

Making healthcare innovation for children a priority

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Dr. Kurt Newman in front of the capitol building

Recently, Kurt Newman, M.D., president and CEO of Children’s National Hospital, authored an opinion piece for the popular political website, The Hill. In the article, he called upon stakeholders from across the landscape to address the significant innovation gap in children’s healthcare versus adults.

As Chair of the Board of Trustees of the Children’s Hospital Association,  Dr. Newman knows the importance of raising awareness among policy makers at the federal and state level about the healthcare needs of children. Dr. Newman believes that children’s health should be a national priority that is addressed comprehensively. With years of experience as a pediatric surgeon, he is concerned by the major inequities in the advancements of children’s medical devices and technologies versus those for adults. That’s why Children’s National is working to create collaborations, influence policies and facilitate changes that will accelerate the pace of pediatric healthcare innovation for the benefit of children everywhere. One way that the hospital is tackling this challenge is by developing the Children’s National Research & Innovation Campus, which will be the nation’s first innovation campus focused on pediatric research.

Pitch Competition Winners

7th Annual Pediatric Device Innovation Symposium

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Melinda Richter and Dr. Newman

The event featured an onstage discussion by Melinda Richter, global head of Johnson & Johnson Innovation – JLABS and Dr. Kurt Newman, M.D., president and CEO of Children’s National Hospital, about the power of collaboration to spur innovation.

The 7th Annual Pediatric Device Innovation Symposium, presented by Children’s National Hospital, recently brought together stakeholders from across the clinical, investor, business and regulatory sectors of pediatric device development for a day-long program focused on closing the wide gap that exists between the number of medical devices developed for adults and the significantly smaller number developed for children.

Co-located with AdvaMed’s The MedTech Conference for the third consecutive year, the symposium featured an opening keynote address by Melinda Richter, global head of Johnson & Johnson Innovation – JLABS, who was later joined Kurt Newman, M.D., president and CEO of Children’s National Hospital, for an on-stage discussion about the power of collaboration to spur innovation.

That collaboration was on display as Dr. Newman and Richter shared details of the recently announced JLABS @ Washington, DC, a 32,000 square-foot facility to be located at the new Children’s National Research & Innovation Campus on the former Walter Reed Army Medical Center campus in the nation’s capital.

“We had this idea at Children’s National to develop the first pediatric research and innovation campus in the world to create a sustainable pipeline and ecosystem of everything needed to bring medical devices from concept to market for children. Seeing what Johnson & Johnson has accomplished with JLABS across the world, we knew they were the right partner,” said Dr. Newman.

Richter highlighted the need to take action, “We have made modest progress in pediatric device innovation, but we need to do better. We need to advance solutions that take into account the unique characteristics of our youngest and most vulnerable of patients. Only then will we achieve real progress for children and their families.” Of all the medical devices approved each year, only 25% are approved for children and most of those are approved for patients over the age of 18. Richter encouraged symposium attendees to leverage collaborations and convenings to move pediatric device development forward and lauded innovators focused on babies and children, calling them “super heroes.”

$150K medical device pitch competition

Pitch Competition Winners

Six innovations that address the significant unmet needs of neonatal intensive care unit (NICU) patients were awarded a total of $150K during the medical device pitch competition at the 7th Annual Pediatric Device Innovation Symposium hosted by Children’s National Hospital at Boston Convention & Exhibition Center. From L to R are: Anthony Sandler, M.D., Children’s National Hospital; Neil Ray, Raydiant Oximetry; Julia Finkel, M.D., AlgometRx, Inc.; Eric Chehab, Ph.D., Novonate; Xina Quan, Ph.D., PyrAmes, Inc.; Mark Lehmkuhle, Epitel, Inc.; Adam Zysk, Ph.D., Rhaeos, Inc.; and Kolaleh Eskandanian, Ph.D., Children’s National Hospital.

Six winners were announced in the symposium’s $150,000 “Make Your Medical Device Pitch for Kids!” competition, sponsored by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) and focused on NICU devices, which the FDA identifies as an area of significant need for innovation. Ten finalists presented their innovations for a panel of 25 expert judges. Each winner receives a $25,000 award and an opportunity to participate in a first-of-its-kind pediatric accelerator program led by MedTech Innovator.

The winning pediatric devices and companies are:

  • AlgometRx, Inc., Washington, D.C. – The AlgometRx Rapid Drug Test is used to detect and monitor neonatal abstinence syndrome, allowing for earlier assessment and intervention of opioid withdrawal to reduce physiological stress.
  • Epitel, Salt Lake City, Utah – Epilog is an inexpensive, discrete and disposable EEG machine that provides real-time monitoring to revolutionize the way neonates suspected of hypoxic-ischemic encephalopathy are managed at community hospitals.
  • Novonate, South San Francisco, Calif. – LifeBubble secures and protects the umbilical catheter insertion site for neonates in intensive care, preventing infection from caregivers and parents.
  • PyrAmes Inc., Cupertino, Calif. – Noninvasive and wireless, the Boppli Band allows for risk- and pain-free continuous blood pressure monitoring for neonates.
  • Raydiant Oximetry, Mountain View, Calif. – Raydiant Oximetry Sensing Systems is a novel, non-invasive technology that more accurately detects fetal distress during labor and delivery, reducing medically unnecessary cesarean deliveries and the occurrence of newborns suffering the consequences of metabolic acidosis.
  • Rhaeos, Inc., Evanston, Ill. – FlowSense is a wearable device that enables noninvasive monitoring of ventricular shunt function in patients who have hydrocephalus, obviating the need for imaging and unnecessary hospital visits and admissions.

“Improved neonatal monitoring devices, such as those among our award winners, can make a critical difference in detecting interventions that could positively impact the long-term developmental trajectory of many children, said Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National and principal investigator of NCC-PDI. “We welcome these winning companies into the NCC-PDI network of device startups and entrepreneurs and look forward to helping them accelerate commercialization so that these innovations can benefit children everywhere as soon as possible.”

Julia Finkel

Children’s National anesthesiologist and innovator Julia Finkel, M.D., delivers a winning pitch for her AlgometRx device for detecting and monitoring neonatal abstinence syndrome.

Award-winner AlgometRx is a spinout company from Children’s National Hospital that was founded by anesthesiologist and pain medicine research chief Julia Finkel, M.D.  A non-invasive, handheld and portable device, AlgometRx captures a digital image of a patient’s pupillary light response and applies a series of propriety algorithms to measure pain type, intensity and drug effects in real time. Designed for use in virtually any clinical setting, Dr. Finkel originally developed this objective pain measurement technology to aid in diagnosing and monitoring non-verbal pediatric patients such as neonates. AlgometRx was also selected earlier this year to join the JLABS location in Philadelphia.

This is the ninth pediatric medical device competition sponsored by NCC-PDI, one of five FDA-funded programs focused on addressing unmet needs for pediatric medical devices. The consortium is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and the A. James Clark School of Engineering at the University of Maryland. NCC-PDI recently added new accelerators BioHealth Innovation and MedTech Innovator and design firm partner, Archimedic.

The symposium also featured four multidisciplinary panel discussions that followed the theme “Pediatric Device Clinical Trials: Forging a Better Path.” Solutions uncovered during these panels will be highlighted in an upcoming whitepaper that will be used to suggest FDA guidance on pediatric device trial conduct and best practices to safely validate medical devices for children more efficiently and effectively.

Vasum Peiris, M.D., chief medical officer, Pediatrics and Special Populations, Center for Devices and Radiological Health, FDA, gave the closing address, which outlined FDA initiatives focused on pediatric device development. David L. Wessel, M.D., senior vice president for the Center for Hospital-Based Specialties at Children’s National, provided an insightful overview of why NICU device development is so important and shared some of the NICU innovations currently in development at Children’s National, which ranks #1 nationally in NICU care.

Gustavo Nino

Gustavo Nino, M.D., honored with national award from American Thoracic Society

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Gustavo Nino

Gustavo Nino, M.D., a pulmonologist who directs the Sleep Medicine program at Children’s National, was honored by the American Thoracic Society with The Robert B. Mellins, M.D. Outstanding Achievement Award in recognition of his contributions to pediatric pulmonology and sleep medicine.

“I am humbled and pleased to be recognized with this distinction,” says Dr. Nino. “This national award is particularly special because it honors both academic achievements as well as research that I have published to advance the fields of pediatric pulmonology and sleep medicine.”

After completing a mentored career development award (K Award) from the National Institutes of Health (NIH), Dr. Nino established an independent research program at Children’s National funded by three different NIH R-level grants, an R01 research project grant; an R21 award for new, exploratory research; and an R4 small business/technology transfer award to stimulate research innovation.

The research team Dr. Nino leads has made important contributions to developing novel models to study the molecular mechanisms of airway epithelial immunity in newborns and infants. He also has pioneered the use of computer-based lung imaging tools and physiological biomarkers to predict early-life respiratory disease in newborns and infants.

Dr. Nino has published roughly 60 peer-review manuscripts including in the “Journal of Allergy and Clinical Immunology,” the “European Respiratory Journal,” and the “American Journal of Respiratory and Critical Care Medicine,” the three top journals in the field of respiratory medicine. He has been invited to chair sessions about sleep medicine during meetings held by the Pediatric Academic Societies, American College of Chest Physicians and the American Thoracic Society (ATS).

Dr. Nino also has served as NIH scientific grant reviewer of the Lung Cellular and Molecular Immunology Section; The Infectious, Reproductive, Asthma and Pulmonary Conditions Section; and The Impact of Initial Influenza Exposure on Immunity in Infants NIH/National Institute of Allergy and Infectious Diseases Special Emphasis Panel.

In addition to his research and academic contributions, over the past five years Dr. Nino has led important clinical and educational activities at Children’s National and currently directs the hospital’s Sleep Medicine program, which has grown to become one of the region’s largest programs conducting more than 1,700 sleep studies annually.

He has developed several clinical multidisciplinary programs including a pediatric narcolepsy clinic and the Advanced Sleep Apnea Program in collaboration with the Division of Ear, Nose and Throat at Children’s National. In addition, Dr. Nino started a fellowship program in Pediatric Sleep Medicine accredited by the Accreditation Council for Graduate Medical Education in collaboration with The George Washington University and has served as clinical and research mentor of several medical students, pediatric residents and fellows.

Dr. Kurt Newman in front of the capitol building

Kurt Newman, M.D., shares journey as a pediatric surgeon in TEDx Talk

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Kurt Newman, M.D., president and chief executive officer of Children’s National, shares his poignant journey as a pediatric surgeon, offering a new perspective for approaching the most chronic and debilitating health conditions. In this independently-organized TEDx event, Dr. Newman also shares his passion for Children’s National and the need to increase pediatric innovations in medicine.

Andrew Dauber

Andrew Dauber, M.D., joins Children’s National as Chief of Endocrinology

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Andrew Dauber

“Researchers, clinicians and medical trainees are pressed for time,” says Andrew Dauber, M.D. “Merging these three arenas into a joint infrastructure powers institutional collaboration and fuels transformative, cutting-edge care.”

Imagine an endocrinology division staffed with endowed researchers, clinicians and specialists, that serves as an engine of innovation, making it easy for pediatricians to make the right referrals, based on the best research, to endocrinologists who can provide families with cutting-edge care.

Andrew Dauber, M.D., MMSc, the new chief of endocrinology at Children’s National, is turning this dream into a reality. Over the next few years, Dr. Dauber will work with a nationally-ranked endocrinology and diabetes center to build a clinical endocrinology research program, housing specialty clinics for Turner’s syndrome, thyroid care and growth disorders, amongst others.

“Researchers, clinicians and medical trainees are pressed for time,” notes Dr. Dauber. “Merging these three arenas into a joint infrastructure powers institutional collaboration and fuels transformative, cutting-edge care.”

To put his real-life hypothesis of providing an engine for innovation into practice, Dr. Dauber led the interdisciplinary growth center at Cincinnati Children’s Hospital Medical Center and organized a Genomics First for Undiagnosed Diseases Program to study genetic clues for undiagnosed diseases. At Boston Children’s Hospital, he was the assistant medical director for the clinical research unit and held academic appointments with Harvard Medical School.

Dr. Dauber finds it’s critically important to merge clinical practice with research and education. He received his medical degree and a Master’s of Medical Sciences in Clinical Investigation from Harvard Medical School. He has published more than 65 studies examining genetic clues to endocrine disorders, with a focus on short stature and growth disorders.

Dr. Dauber conducted the majority of his research – ranging from studying genetic clues for rare growth disorders and causes of precocious puberty to genes that regulate the bioavailability of IGF1, insulin-like growth factor – while counseling patients, advising students and fellows, managing grants, reviewing studies and speaking at international pediatric endocrinology conferences.

He’s harnessing this data by combining genomic insights with electronic health records and patient registries. While some of this information can be used immediately to identify a high-risk patient, other conditions may take years to understand. Dr. Dauber views this as an investment in the future of pediatric endocrinology.

“I’m excited to join Children’s National and to work in Washington, where we can power our city and the nation with premier partnerships and collaboration,” adds Dr. Dauber. “In addition to using genetic clues to investigate growth disorders, we’re just as enthusiastic about investing in and expanding access to youth-focused diabetes education and care.”

The Division of Diabetes and Endocrinology works with the National Institutes of Health, conducts independent research and received support from the Washington Nationals Dream Foundation for its diabetes program, the largest pediatric diabetes program in the region, which provides community education and counsels 1,800 pediatric patients each year.

IV Bag

New study examines treatment for diabetic ketoacidosis

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IV Bag

Brain injuries that happen during episodes of diabetic ketoacidosis (DKA) – where the body converts fat instead of sugar into energy, and where the pancreas is unable to process insulin, such as in type 1 diabetes – are rare, and happen in less than 1 percent of DKA episodes, but these injuries can carry lasting consequences – including mild to severe neurological damage.

A new 13-center, randomized, controlled trial published on June 13, 2018, in the New England Journal of Medicine finds two variables – the speed of rehydration fluids administered to patients and the sodium concentrations in these intravenous fluids – don’t impact neurological function or brain damage.

“One medical center would never be able to study this independently because of the relatively small volume of children with DKA that present to any one site,” says Kathleen Brown, M.D., a study author, the medical director of the emergency medicine and trauma center at Children’s National Health System and a professor of pediatrics and emergency medicine at George Washington University School of Medicine. “The strength of this research lies in our ability to work with 13 medical centers to study almost 1,400 episodes of children with DKA over five years to see if these variables make a difference. The study design showcases the efficiency of the Pediatric Emergency Center Applied Research Network, or PECARN, a federally-funded initiative that powers collaboration and innovation.”

Researchers have speculated about the techniques of administering intravenous fluids, specifically speed and sodium concentrations, to patients experiencing a DKA episode, with many assuming a faster administration rate of fluids would produce brain swelling. Others argued, from previous data, that these variables may not matter – especially since higher levels of brain damage were noted among children with higher rates of dehydration before they were treated. Some thought DKA created a state of inflammation in the brain, which caused the damage, and that speed and sodium concentration wouldn’t reverse this initial event. The researchers set out to determine the answers to these questions.

The PECARN research team put the data to the test: They created a 2-by-2 factorial design to test the impact of providing 1,255 pediatric patients, ages zero to 18, with higher (.9 percent) and lower (.45 percent) concentrations of sodium chloride at rapid and slow-rate administration speeds during a DKA episode. They administered tests during the first DKA episode and again during a recurrent episode. After analyzing 1,389 episodes, they found that the four different combinations did not have a statistically significant impact on the rate of cognitive decline during the DKA episode or during the 2-month and 6-month recovery periods.

“One of the most important lessons from this study is that diabetic ketoacidosis should be avoided because it can cause harm,” says Dr. Brown. “But the best way to treat diabetic ketoacidosis is to prevent it. Parents can monitor this by checking blood sugar for insulin control and taking their children for treatment as soon as they show signs or symptoms that are concerning.”

According to the National Institute of Diabetes and Kidney Disease, symptoms of diabetic ketoacidosis include nausea and vomiting, stomach pain, fruity breath odor and rapid breathing. Untreated DKA can lead to coma and death.

An accompanying video and editorial are available online in the New England Journal of Medicine.

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the Health Resources and Services Administration. The PECARN DKA FLUID ClinicalTrials.gov number is NCT00629707.

Children’s National Health System’s Division of Pediatric Emergency Medicine has been a lead site for the PECARN network since its inception in 2001.