pediatrics Archives

Bloom Standard 2 Portable UltraSound Device being used on a baby

Novel ultrasound device gets FDA breakthrough designation with Children’s National support

March 6, 2024

The Bloom Standard device enables autonomous, hands-free ultrasound scans to be performed anywhere, by any user.

A novel ultrasound device developed by Bloom Standard received the Food and Drug Administration’s valued breakthrough device designation with the help of Children’s National Hospital and support provided through an FDA-funded grant that established the Alliance for Pediatric Device Innovation (APDI), formerly branded as the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). The grant funding, clinical expertise and regulatory guidance demonstrate the hospital’s leadership in pediatric medical device innovation and its commitment to supporting critically needed advancements.

“In many ways, Children’s National has been a key resource as we continue this journey from concept to commercialization,” said Annamarie Saarinen, co-founder of Bloom Standard and the mother of an infant who was diagnosed with a critical heart defect days after her birth.

Why we’re excited

Children’s National Innovation Ventures and APDI leaders saw the value in the Bloom Standard innovation: a device that enables autonomous, hands-free ultrasound scans to be performed anywhere, by any user. The FDA granted the innovation its breakthrough device designation to help streamline the regulatory process so that patients and healthcare providers have more timely access to devices.

Bloom Standard can potentially save lives and improve outcomes for newborns and babies with cardiac and respiratory issues. The technology can eliminate the delay that often occurs for infants who need ultrasound imaging because their medical location lacks the technology. Bloom Standard’s portability and ease of use can potentially reduce mortality and poor outcomes tied to delayed detection of lung and cardiac conditions. It has potential cost savings, too.

Children’s National leads the way

Children’s National supported this novel medical technology for children by engaging in multiple steps through the regulatory process:

Grant funding: Bloom Standard participated in pediatric pitch competitions in 2020 and 2022 and each time, because of the merits of the device, was awarded grant funding that helped to support its progression.
Regulatory support: Children’s National pediatrician Francesca Joseph, M.D., brings a wealth of expertise navigating the FDA’s regulatory processes and currently service as co-investigator and core regulatory expert for the pediatric device consortium led by Children’s National. Saarinen called Dr. Joseph “an invaluable resource,” explaining that her input and support has been very significant in Bloom Standard’s understanding and navigation of FDA processes. “For a small device company like ours, she has been a lifeline,” Saarinen said.

Saarinen says she is grateful for the continuing relationship with Children’s National as her company enters its next phase on the journey to commercialization.

Children’s National Vice President and Chief Innovation Officer Kolaleh Eskandanian, Ph.D., MBA, PMP, who directs the FDA-funded Alliance for Pediatric Device Development, says that nurturing and supporting life-saving technologies like Bloom Standard is important because the device addresses a dire unmet need in the pediatric space, especially in settings with fewer resources and in public health emergency situations. “Advancements in children’s medical devices continue to lag behind those of adults, and we must use our research and innovation infrastructure to help close that gap and to influence policy changes.”

Community-wide program to support teen parents serves as a model for engagement

June 14, 2023

More than 500 adolescent mothers, caregivers and community members benefitted from a coordinated “collective impact” model to provide support aimed at addressing the litany of strains faced by teen parents, according to a case study published Wednesday in the journal Pediatrics.

Known as the District of Columbia Network for Parenting and Expectant Teens (DC NEXT), the model used well-tested pillars of community organization to provide services and care that bolstered the well-being of pregnant and expectant teens in the city. The case study found that the 3-year-old program, which included teen advisors to help guide the mission, could serve as a model in other areas with high rates of teen parents.

“There’s no system of care for teen parents in Washington, D.C., or really anywhere in our country,” said Yael Smiley, M.D., Children’s National Hospital pediatrician and the study’s lead author. “Our coalition came together to connect the resources and the people who care about young parents and their families to improve their health, their outcomes, their well-being, and set them up for success. We fuse representatives from healthcare, education and housing policy — people who care about creating the very best outcomes possible.”

The patient benefit

More than 140,000 teens became parents in 2021 in the United States. In Washington, D.C., more than 300 babies are born to teens each year, and the rate of births to young teens ages 15 to 17 is double the national average. These young parents often face barriers to childcare and education and poor birth outcomes, often stemming from a lack of access to prenatal care.

To address these obstacles, the network assembled a city-wide network in 2020 to follow the five pillars of an evidence-based “collective impact” model:

Create a common agenda
Design shared measurement systems
Host mutually reinforcing activities
Foster continuous communication
Rely on trusted backbone support

What’s unique

DC NEXT was housed at the District of Columbia Primary Care Association (DCPCA), which received the 3-year, $4.5 million federal grant and provided the leadership. At Children’s National, Dr. Smiley led a team that partnered with DCPCA and Howard University to direct a network of community clinics, nonprofits and other organizations whose mission was to support adolescent parents. Hundreds of client-facing staff members were trained to provide trauma-informed, human-centered care. DC NEXT also engaged directly with teen mothers through well-being surveys that led to improved access to essential programs, including resources for housing and food security. Over 550 young parents and caregivers have been impacted by the program.

The leadership quickly realized that the teen parents needed a voice and created a “context team” of paid teen advisors who provided insights into their unique experiences and needs as parents. They help set the agenda, choose program offerings and tailor communications to their peers.

“If the network can continue to grow and support young parents to achieve their health and well-being goals, the impact will be felt across generations,” said Dr. Smiley.

Five winners selected in prestigious pediatric device competition

October 26, 2022

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announced five awardees chosen in its prestigious “Make Your Medical Device Pitch for Kids!” competition. Each received a share of $150,000 in grant funding from the U.S. Food and Drug Administration (FDA), with awards ranging from $20,000 to $50,000 to support the advancement of pediatric medical devices.

Consistent with its mission of addressing the most pressing pediatric device needs, this year’s competition, moderated by MedTech Innovator, welcomed medical device technologies that address the broad unmet needs of children. The pediatric pitch event was part of the 10^th Annual Symposium on Pediatric Device Innovation, co-located with the MedTech Conference, powered by AdvaMed.

This year’s pediatric device innovation awardees are:

CorInnova – Houston, TX – Minimally invasive biventricular non-blood contacting cardiac assist device to treat heart failure.
Innovation Lab – La Palma, CA – Mechanical elbow brace stabilizes tremors for pediatric ataxic cerebral palsy to improve the performance of Activities of Daily Living (ADLs).
Prapela – Biddeford, ME – Prapela’s incubator pad is the first innovation to improve the treatment of apnea of prematurity in over twenty years.
Tympanogen – Richmond, VA – Perf-Fix replaces surgical eardrum repair with a nonsurgical clinic procedure
Xpan – Concord, Ont. – Xpan’s universal trocar enables safest and most dynamic access and effortless upsizing in conventional/mini/robotic procedures.

“We are delighted to recognize these five innovations with critical NCC-PDI funding that will support their journey to commercialization. Improving pediatric healthcare is not possible without forward-thinking companies that seek to address the most dire unmet needs in children’s health,” 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 know all too well how challenging it is to bring pediatric medical devices to market, which is why we have created this rich ecosystem to identify promising medical device technologies and incentivize investment. We congratulate this year’s winning innovators and applaud their efforts to help bridge these important care gaps that are impacting children.”

Empowering Innovators

NCC-PDI is one of five consortia 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 progress of adult medical devices. NCC-PDI is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National and the A. James Clark School of Engineering at the University of Maryland, with support from partners MedTech Innovator and design firm Archimedic.

A pediatric accelerator program, powered by MedTech Innovator, the largest medical device accelerator in the world, is a key part of the network of resources and experts that NCC-PDI provides in support of pediatric innovators. All five of this year’s competition finalists had an opportunity to participate in the year-long accelerator program.

To date, NCC-PDI has mentored 250 medical device projects to help advance their pediatric innovations throughout all stages of the total product life cycle (TPLC).

Eskandanian adds that supporting the progress of pediatric innovators is a key focus of the new Children’s National Research & Innovation Campus, a one-of-its-kind ecosystem that drives discoveries that save and improve the lives of children. On a nearly 12-acre portion of the former, historic Walter Reed Army Medical Center in Northwest Washington, D.C., Children’s National has combined its strengths with those of public and private partners, including industry, universities, federal agencies, start-up companies and academic medical centers. The campus provides a rich environment of public and private partners which, like the NCC-PDI network, will help bolster pediatric innovation and commercialization.

A total of $150K was awarded to five pediatric innovations during the medical device pitch competition at the 10th Annual Symposium on Pediatric Device Innovation, hosted by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). Award winners include (from left to right): Zaid Atto, founder and CEO at Xpan; John Konsin, CEO and co-founder of Prapela; Elaine Horn-Ranney, co-founder and CEO at Tympanogen; William Altman, CEO at CorInnova; and Sharief Taraman, pediatric neurologist at CHOC and University of California-Irvine partnering with Innovation Lab. (Photo credit: Children’s National Hospital)

screenshot of conversation between Dr. Beers and Simone Biles

Dr. Lee Beers speaks with Olympic gold medalist Simone Biles about mental health

October 18, 2021

Lee Savio Beers, M.D., F.A.A.P., medical director of Community Health and Advocacy at the Child Health Advocacy Institute (CHAI) at Children’s National Hospital and president of the American Academy of Pediatrics (AAP), delivered the President’s Address to AAP members around the world and held a keynote conversation with Olympic gold medalist Simone Biles about mental health during AAP’s National Conference and Exhibition.

After being introduced by her children, Charlotte and Jonah, Dr. Beers thanked AAP members around the world for their ability to adapt and provide quality care to patients throughout the COVID-19 pandemic. “The COVID-19 pandemic has changed our collective calculus of uncertainty, yet you continue to adapt and adjust to provide quality care in your clinics, emergency departments, ICU’s and exam rooms,” said Dr. Beers.

Dr. Beers continued by reflecting on accomplishments that AAP members and volunteers were able to achieve over the last year including the establishment of community immunization efforts, interim guidance provided on numerous pandemic-related issues and bi-weekly COVID-19 townhalls and educational sessions.

Shortly after her address, Dr. Beers sat down with Simone Biles to discuss the importance of advocating for mental health as an athlete.

During their conversation, Biles discussed the importance of making her mental health a priority by withdrawing from several events during the 2020 Tokyo Olympics. She reflected on the outpouring support she received and how it made her feel.

Biles also offered advice for youth dealing with mental health issues and stressed the importance of reaching out to parents or peers so they can get the help and support they need.

AAP’s National Conference and Exhibition, held from October 8 through October 11, serves as an opportunity to keep pediatric providers abreast of the latest best practices in pediatrics and strives to meet participants’ identified educational needs and support their life-long learning with a goal of improving care for children and families.

Speaker and presentation information can be found here.

Simone Biles discussed the importance of making mental health a priority with Dr. Lee Savio Beers.

Children’s National provides clinical validation, IP for health challenge designed to advance pediatric innovation

June 24, 2021

girl with smart brain imagination doodle

Reinforcing its commitment to expanding innovation in pediatric care, Children’s National Hospital has joined a strategic partnership with the Center for Advancing Innovation (CAI) , along with collaborators Resonance Philanthropies and Digital Infuzion, to launch the 2021-2022 Innovate Children’s Health Challenge. This year’s event, Innovate Children’s Health II, focuses on technologies that address pandemic resiliency and prevention in the pediatric population and seeks to advance diagnostics, therapeutics and digital health tools that address pediatric mental health.

The initiative matches entrepreneurial talent with breakthrough inventions to launch startups and connect them with capital. For this challenge, more than 15 startups will compete for the opportunity to commercialize promising mental health solutions from a variety of research partners, including Children’s National. Nationally recognized for its expertise and commitment to innovation in pediatric care, Children’s National will contribute to the clinical validation of selected technologies.

“In addition to our role in providing clinical validation, this initiative provides the opportunity for intellectual property (IP) developed by leading clinicians at Children’s National Hospital, as well as other great pediatric institutions, to be considered for partnership with entrepreneurs who can help bring these technologies to market,” says Kolaleh Eskandanian, PhD, MBA, PMP, vice president and chief innovation officer at Children’s National Hospital. “Our mission is to improve children’s healthcare and Innovate Children’s Health II is a great way to harness this trifecta model — innovation, talent and capital — in order to develop breakthrough solutions that address the unique needs of pediatric patients.”

“In addition to our role in providing clinical validation, this initiative provides the opportunity for intellectual property (IP) developed by leading clinicians at Children’s National Hospital, as well as other great pediatric institutions, to be considered for partnership with entrepreneurs who can help bring these technologies to market,” says Kolaleh Eskandanian, PhD, MBA, PMP, vice president and chief innovation officer at Children’s National Hospital.

There are three ways to participate in Innovate Children’s Health II:

Entrepreneurial-minded people, alone or as members of multidisciplinary teams, may compete to commercialize vetted inventions;
Existing startups may enter the challenge with other public health-related inventions, including their own and/or others to which they have access;
Participants may submit ideas that they believe will improve emergency preparedness and pandemic response.

Inventors and technology licensing officers may submit inventions to be evaluated and made available for licensing to challenge winners. Innovate Children’s Health II will accept invention submissions until September 1, 2021. Anyone with an entrepreneurial spirit and interest in stopping current and future pandemics is invited to sign up to learn more about the challenge. Teams may also enroll in the challenge to choose a featured invention, bring in a third-party invention or get matched with an invention based on area of interest.

“The COVID-19 pandemic has made our children anxious, depressed and pessimistic about their futures. Through Innovate Children’s Health II, CAI and our strategic partner Children’s National will strive to give our children hope,” says Rosemarie Truman, founder and CEO of CAI. “We are grateful to Digital Infuzion and Resonance Philanthropies for their support, which makes this challenge possible.”

Eskandanian adds that supporting and expanding pediatric innovation is a key focus of the new Children’s National Research & Innovation Campus, the 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 will help bolster pediatric innovation and commercialization.

Decision support tool for chest pain reduces unnecessary cardiology referrals

May 27, 2021

A new study in the journal Medical Decision Making reports how well a new decision-support tool assisted pediatricians to apply validated criteria and reduce referrals to cardiology for children with chest pain.

In 2017, cardiologists from Children’s National Hospital and other centers published criteria to reliably detect risk for cardiac disease in children presenting with chest pain. However, despite the validated criteria published more than three years ago, as many as half of the children with chest pain who are referred to cardiology from a primary care doctor continue not to meet these criteria.

In response, the cardiology and Children’s National Pediatricians & Associates (CNP&A) team developed a decision support tool based on the validated criteria that was then incorporated into the CNP&A electronic medical record. A study, Promoting Judicious Primary Care Referral of Patients with Chest Pain to Cardiology: A Quality Improvement Initiative, in the journal Medical Decision Making reports how well the tool assisted pediatricians to apply the criteria and reduced referrals to cardiology for children who do not meet criteria for consultation by a pediatric cardiac specialist.

“As stated by the Institute for Healthcare Improvement, improving the U.S. health care system requires simultaneous pursuit of three aims: improving the experience of care, improving the health of populations and reducing per capita costs of health care. Known as the Triple Aim, such improvement includes reducing referrals to specialists for conditions that could be managed in primary care. Fewer unnecessary referrals can reduce costs by decreasing unnecessary testing and specialist time and also has the potential to improve the patient experience by providing care in the medical home,” the authors note.

The study highlights the results of a focused healthcare improvement initiative that engaged pediatricians, nurses, trainees and nurse practitioners at primary care practices to implement the new decision support tool. With the tool in place, the team saw a 71% reduction (from 17% referred to 5% referred) in cardiology referrals for children presenting to cardiology who did not meet the criteria for a referral. At almost one year of follow up, the reduction in referrals based on the criteria did not lead to any missed detections of potential life-threatening events, either.

“This study shows that patients presenting with chest pain who do not meet clinical criteria for referral can be safely and confidently managed at their medical home by their primary care provider,” says Ashraf Harahsheh, M.D., director of Quality Outcomes in Cardiology at Children’s National Heart Institute, who led the study with colleagues. “Avoiding unnecessary referrals to cardiology may help prevent missed work and school days for families and children and will also make sure that the children who truly need a cardiology evaluation can be evaluated quickly.”

This collaboration between our specialty colleagues and primary care clinicians improves care for our patients by bringing an evidence-based approach to managing a condition in a manner that reduces the burden of anxiety for families by addressing their concerns in their medical home,” adds Ellen Hamburger, M.D., study co-author and medical director of the Pediatric Health Network.

After the success of the project at Children’s National Hospital in partnership with the CNP&A, the team is now in talks with UPMC Children’s Hospital of Pittsburgh and Phoenix Children’s Care Network to expand the quality improvement initiative to their primary care networks as well.

Ashraf S Harahsheh, Ellen K Hamburger, Lena Saleh, Lexi M Crawford, Edward Sepe, Ariel Dubelman, Lena Baram, Kathleen M Kadow, Christina Driskill, Kathy Prestidge, James E Bost, Deena Berkowitz. Promoting Judicious Primary Care Referral of Patients with Chest Pain to Cardiology: A Quality Improvement Initiative. Med Decis Making. 2021 Mar 3;272989X21991445. Online ahead of print. DOI: 10.1177/0272989X21991445

Children’s National Hospital at the 2021 Pediatric Academic Societies Meeting

April 28, 2021

Attending the 2021 Pediatric Academic Societies meeting this week? There will be over 20 Children’s National Hospital-affiliated participants at this year’s meeting. We have compiled their sessions into a mini schedule:

Name	Program/Department	Session and role	Date	Time
Taeun Chang, M.D.	Neonatal Neurology and Neurocritical Care Program	PAS Postgraduate Course: Neonatal Neurology: HIE-focused Project-Based (Chair)	Friday, 30 April	9:00 AM – 4:00 PM CT
Taeun Chang, M.D.	Neonatal Neurology and Neurocritical Care Program	PAS Postgraduate Course: Neonatal Neurology: HIE-focused Project-Based (Presenter)	Friday, 30 April	9:30 AM – 10:00 AM CT
Yuan-Chiao Lu, Ph.D.	Developing Brain Research Laboratory	Cardiology Poster: Care of the Fetus and Newborn with CHD (Presenter)	Saturday, May 1	4:30 PM – 4:45 PM CT
Chidiogo Anyigbo, M.D., M.P.H.	General and Community Pediatrics	Poster: Health Services Research I (Presenter)	Saturday, May 1	5:15 PM – 5:30 PM CT
Panagiotis Kratimenos, M.D.	Neonatology	Platform (moderator)	Saturday, May 1	4:30 PM – 6:00 PM CT
Sudeepta Basu, MBBS, MS	Neonatology	Hot Topic Symposia: The Neurological Implications of Abnormal Glycemia in Neonatal Encephalopathy and Prematurity (Chair)	Sunday, May 2	9:00 AM – 12:00 PM CT
Sudeepta Basu, MBBS, MS	Neonatology	Hot Topic Symposia: The Neurological Implications of Abnormal Glycemia in Neonatal Encephalopathy and Prematurity (Presenter)	Sunday, May 2	9:55 AM – 10:15 AM CT
Ashraf Harahsheh, M.D., F.A.C.C., F.A.A.P.	Cardiology	Cardiology: Heart Disease in the Older Child	Sunday, May 2	10:00 AM – 12:00 PM CT
Rana F. Hamdy, M.D., MPH, MSCE	Infectious Diseases	Expanding Outpatient Antibiotic Stewardship: Practical Strategies, Novel Settings, and Sociobehavioral Influences (Presenter)	Sunday, May 2	10:15 AM – 10:30 AM CT
Rana F. Hamdy, M.D., MPH, MSCE	Infectious Diseases	Hot Topic Debates: Antibiotic Use in Hospitalized Children (Chair)	Sunday, May 2	1:00 PM – 3:00 PM CT
John Idso, M.D.		Critical Care Poster: Resuscitation and Potpourri (presenter)	Sunday, May 2	2:20 PM – 2:30 PM CT
Michael Shoykhet, M.D., Ph.D.	Critical Care Medicine	Critical Care Poster: Resuscitation and Potpourri (presenter)	Sunday, May 2	2:20 PM – 2:30 PM CT
Panagiotis Kratimenos, M.D.	Neonatology	Neonatal Neurology: Basic & Translational I (moderator)	Sunday, May 2	4:30 PM – 6:00 PM CT
Monika Goyal, M.D.	Emergency Medicine and Trauma Services	Injury Prevention (moderator)	Sunday, May 2	10:00 AM – 12:00 PM CT
Ioannis Koutroulis, M.D., Ph.D., M.B.A.	Genetic Medicine Research	Emergency Medicine III (moderator)	Tuesday, May 4	2:00 PM – 4:00 PM CT
Sudeepta Basu, MBBS, MS	Neonatology	Neonatal Neurology: Clinical: HIE and Other Insults (moderator)	Tuesday, May 4	4:30 PM – 6:00 PM CT
Josepheen De Asis-Cruz, M.D., Ph.D.	Center for the Developing Brain	Neonatal Neurology: Clinical: HIE and Other Insults (presenter)	Tuesday, May 4	4:30 PM – 4:45 PM CT
Asad Bandealy, M.D., MPH Priti Bhansali, M.D. Monika Goyal, M.D. Sabah Iqbal, M.D. Kavita Parikh, M.D. Shilpa Patel, M.D.		Workshop. ThisIsSTILLOurLane: Protect Kids, Not Guns	Monday, May 10	9:00 AM – 11:00 AM CT
Cara Lichtenstein, M.D.	General and Community Pediatrics	APA Injury Control/Advocacy Training Combined SIG (SIG Chair)	Monday, May 10	1:00 PM – 3:00 PM CT
Terry Kind, M.D., MPH	General and Community Pediatrics	APA Women in Medicine / Qualitative Research Combined SIG (SIG Chair)	Wednesday, May 12	9:00 AM – 11:00 AM CT

Phase I: April-30-May 4 and Phase II: May 10-June 4

PAS 2021 Virtual Schedule

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

April 12, 2021

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.

“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 8^th 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.

Children’s National joins international AI COVID-19 initiative

October 28, 2020

Children’s National Hospital is the first pediatric partner to join an international initiative led by leading technology firm NVIDIA and Massachusetts General Brigham Hospital, focused on creating solutions through machine and deep learning to benefit COVID-19 healthcare outcomes.

Children’s National Hospital is the first pediatric partner to join an international initiative led by leading technology firm NVIDIA and Massachusetts General Brigham Hospital, focused on creating solutions through machine and deep learning to benefit COVID-19 healthcare outcomes. The initiative, known as EXAM (EMR CXR AI Model) is the largest and most diverse federated learning enterprise, comprised of 20 leading hospitals from around the globe.

Marius George Linguraru, D.Phil., M.A., M.Sc., principal investigator at the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital, noted that one of the core goals of the initiative is to create a platform which brings resources together, from a variety of leading institutions, to advance the care of COVID-19 patients across the board, including children.

“Children’s National Hospital is proud to be the first pediatric partner joining the world’s leading healthcare institutions in this collaboration to advance global health,” says Linguraru. “We are currently living in a time where rapid access to this kind of global data has never been more important — we need solutions that work fast and are effective. That is not possible without this degree of collaboration and we look forward to continuing this important work with our partners to address one of the most significant healthcare challenges in our lifetime.”

A recent systematic review and meta-analysis from Children’s National Hospital became another core contribution to understanding how children are impacted by COVID-19. Led by Linguraru and accepted to be published in Pediatric Pulmonology, it offers the first comprehensive summary of the findings of various studies published thus far that describe COVID-19 lung imaging data across the pediatric population.

The review examined articles based on chest CT imaging in 1,026 pediatric patients diagnosed with COVID-19, and concluded that chest CT manifestations in those patients could potentially be used to prompt intervention across the pediatric population.

“Children’s National Hospital is proud to be the first pediatric partner joining the world’s leading healthcare institutions in this collaboration to advance global health,” says Marius George Linguraru, D.Phil., M.A., M.Sc.

“Until this point, pediatric COVID-19 studies have largely been restricted to case reports and small case series, which have prevented the identification of any specific pediatric lung disease patterns in COVID-19 patients,” says Linguraru. “Not only did this review help identify the common patterns in the lungs of pediatric patients presenting COVID-19 symptoms, which are distinct from the signs of other viral respiratory infections in children, it also provided insight into the differences between children and adults with COVID-19.”

Earlier this month, NVIDIA announced the EXAM initiative had – in just 20 days – developed an artificial intelligence (AI) model to determine whether a patient demonstrating COVID-19 symptoms in an emergency room would require supplemental oxygen hours – even days – after the initial exam. This data ultimately aids physicians in determining the proper level of care for patients, including potential ICU placement.

The EXAM initiative achieved a machine learning model offering precise prediction for the level of oxygen incoming patients would require.

In addition to Children’s National Hospital, other participants included Mass Gen Brigham and its affiliated hospitals in Boston; NIHR Cambridge Biomedical Research Centre; The Self-Defense Forces Central Hospital in Tokyo; National Taiwan University MeDA Lab and MAHC and Taiwan National Health Insurance Administration; Tri-Service General Hospital in Taiwan; Kyungpook National University Hospital in South Korea; Faculty of Medicine, Chulalongkorn University in Thailand; Diagnosticos da America SA in Brazil; University of California, San Francisco; VA San Diego; University of Toronto; National Institutes of Health in Bethesda, Maryland; University of Wisconsin-Madison School of Medicine and Public Health; Memorial Sloan Kettering Cancer Center in New York; and Mount Sinai Health System in New York.

Real-world evidence and the impact on pediatric device innovation

October 16, 2020

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

The 8^th 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, 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.

William D. Gaillard, M.D., elected president of the American Epilepsy Society

January 15, 2020

“The AES, is one of the oldest neurological professional organizations in the country dedicated to the scientific investigation, exchange of clinical information and eradication of epilepsy and associated disorders, and I’m honored to serve as the new president,” Dr. Gaillard said.

In early December 2019, William D. Gaillard, M.D., chief of the Divisions of Child Neurology, Epilepsy and Neurophysiology at Children’s National Hospital, began his term as president of the American Epilepsy Society (AES) at the annual meeting in Baltimore. The AES is a medical and scientific society with over 4,000 members consisting of clinicians, scientists investigating basic and clinical aspects of epilepsy, and other professionals interested in seizure disorders.

“The AES, is one of the oldest neurological professional organizations in the country dedicated to the scientific investigation, exchange of clinical information and eradication of epilepsy and associated disorders, and I’m honored to serve as the new president,” Dr. Gaillard said.

Dr. Gaillard’s clinical research focuses on the use of advanced imaging to investigate the effect of childhood epilepsy on brain structure and function with an emphasis on cognitive systems. His group also develops and implements imaging strategies to improve epilepsy outcomes.

In addition, Dr. Gaillard, an active participant in AES activities, has served as treasurer and as chair of the Clinical Investigator Workshop and Pediatric Content Committees. He also serves as an associate editor for the journal Epilepsy Research, and as a regular reviewer on AES and Epilepsy Foundation study sections.

As division chief of Child Neurology, Epilepsy and Neurophysiology, Dr. Gaillard directs a team of pediatric specialists who see thousands of patients each year. Dr. Gaillard has worked throughout his career to care for children and young adults with epilepsy from the onset of seizures through novel therapeutic interventions, medication trials and, when appropriate, surgery. Treatment options at Children’s National addresses the full range of the condition, including problems of difficult-to-control epilepsy. Additionally, treatment includes the concurrent social, education and emotional issues faced by children with the condition and their families.

His academic appointments include Professor of Pediatrics and Neurology at George Washington University, Professor of Neurology at Georgetown University, and Professor (adjunct), Hearing and Speech, University of Maryland, College Park.

TAA-Ts as therapy for tumors

August 1, 2019

“The T cell immunotherapy regimen resulted in prolonged disease stabilization in patients who previously experienced rapid tumor progression,” says Holly Meany, M.D. “The therapy could prove to be an important component of immunotherapy for patients with solid tumor malignancies.”

In a study published in the Journal of Clinical Oncology, researchers from Children’s National Health System uncovered tumor-associated antigen cytotoxic T cells (TAA-Ts) that represent a new and potentially effective nontoxic therapeutic approach for patients with relapsed or refractory solid tumors.

The Phase 1 study led by Children’s National pediatric oncologists Holly Meany, M.D., and Amy B. Hont, M.D., represented the first in-human trial investigating the safety of administering TAA-Ts that target Wilms Tumor gene 1, a preferentially expressed antigen of melanoma and survivin in patients with relapsed/refractory solid tumors.

“These are exciting clinical results using a novel ‘first in-human’ T cell therapy,” said Catherine Bollard, MB.Ch.B., M.D., director of the Center for Cancer and Immunology Research at Children’s Research Institute. “This T cell therapy was safe and appeared to prolong patients’ time to progression which suggests that we can now use this novel treatment as a combination therapy to hopefully achieve long-term remissions in pediatrics and adults with relapsed/refractory solid tumors.”

During the Phase 1 trial, TAA-Ts products were generated from autologous peripheral blood and were infused over three dose levels. Patients were then eligible for up to eight infusions that were administered four to seven weeks apart.

Of the 15 evaluable patients, 11 were with stable disease or better at 45 days post-infusion and were defined as responders. Patients who were treated at the highest dose level showed the best clinical outcomes, with a 6-month progression-free survival rate of 73% after TAA-Ts infusion, an improvement as compared with prior therapy.

Overall, the Phase 1 trial of TAA-Ts resulted in safely induced disease stabilization and was associated with antigen spreading and a reduction in circulating tumor-associated antigen DNA levels in patients with relapsed/refractory solid tumors before infusion.

“The T cell immunotherapy regimen resulted in prolonged disease stabilization in patients who previously experienced rapid tumor progression,” said Dr. Meany. “The therapy could prove to be an important component of immunotherapy for patients with solid tumor malignancies,” she added.

The other researchers that contributed to this work are as follows: Amy B. Hont, M.D.; C. Russell Cruz, M.D., Ph.D.; Robert Ulrey, M.S.; Barbara O’Brien, B.S.; Maja Stanojevic, M.D.; Anushree Datar, M.S.; Shuroug Albihani, M.S.; Devin Saunders, B.A.; Ryo Hanajiri, M.D., Ph.D.; Karuna Panchapakesan, M.S.; Sam Darko, M.S.; Payal Banerjee, M.S.; Maria Fernanda Fortiz, B.S.; Fahmida Hoq, MBBS, M.S.; Haili Lang, M.D.; Yunfei Wang, Dr.PH.; Patrick J. Hanley, Ph.D.; Jeffrey S. Dome, M.D., Ph.D.; Catherine M. Bollard, M.D.; and Holly J. Meany, M.D.

Surgical home program for spinal fusion achieves long-term success

November 9, 2018

“Our primary goal was to improve the value of care for children with scoliosis and their families,” says Dr. Oetgen. “Even better, we’ve shown that this model can be used consistently over time to maintain the benefits it delivers to this patient population.”

“Creating an effective process that benefits patients, is sustainable long term and doesn’t increase costs is one of the most challenging parts of any new procedure, both in health care and beyond,” says Matt Oetgen, M.D., chief of Orthopaedic Surgery and Sports Medicine at Children’s National.

Dr. Oetgen’s team accomplished this feat when building the Children’s National Spinal Fusion Surgical Home. The team used LEAN process mapping at the outset to engage a broad group of care providers who established a collaborative environment that empowered and engaged everyone to take ownership over a new care pathway for every patient who undergoes posterior spinal fusion surgery at the hospital.

This unique model designed using proven business process development tools has allowed patients require fewer pain medications after surgery and have shorter stays in the hospital. Even better, the team has maintained the integrity of the pathway consistently over a longer period of time than any other pediatric spinal fusion care model to date.

“Our primary goal was to improve the value of care for children with scoliosis and their families,” says Dr. Oetgen, who was the study’s lead author. “Even better, we’ve shown that this model can be used consistently over time to maintain the benefits it delivers to this patient population.”

The team conducted a retrospective analysis of prospective data from all patients (213) undergoing posterior spinal fusion at Children’s National Health System from 2014 to 2017, a period of time that captures nearly one year before implementation of the new pathway and 2.5 years after implementation. The outcomes were reported in the Journal of Bone and Joint Surgery.

As pressure builds to increase the value of care, many hospital systems are trying standardized care pathways for many complex conditions, in an effort to decrease care variability, improve outcomes and decrease cost. Previous research has shown the effectiveness of a variety of standardized pathways with wide ranging goals for spinal fusion procedures, however, most published studies have focused only on the initial success of these pathways. This study is the first to look at the implementation over a period of 2.5 years to gauge whether the process and its effectiveness could be maintained long term.

The authors attribute physician buy-in across disciplines and strict adherence to pathway processes as key to the success of this model. In addition, the team created standardized educational procedures for onboarding new care providers and implemented standardized electronic order sets for both orthopaedic and anesthesia services to make the pathway easy to maintain with little deviation over time. Lean process mapping at the outset included a broad group of care providers who established a collaborative environment that empowered and engaged the entire team to take ownership over the new process.

“We used proven business models for culture change that were critical to the success of this program,” Dr. Oetgen says. “We’re proud of the model we have created and think it would work well in other pediatric hospitals with similar patient populations.”

Eradicating epilepsy with Visualase

August 29, 2018

Chima Oluigbo, M.D., and his team are using Visualase to identify and eliminate seizure foci and provide patients with a minimally invasive procedure for treating epilepsy.

About one in 26 people will be diagnosed with epilepsy in their lifetime. That adds up to about 3.4 million people in the U.S., or about 1 percent of the population nationwide. This condition can have huge consequences on quality of life, affecting whether children will learn well in school, eventually drive a car, hold down a job or even survive into adulthood.

For most of those that develop epilepsy, medications can keep seizures in check. However, for about a third of patients, this strategy doesn’t work, says Chima Oluigbo, M.D., an attending neurosurgeon at Children’s National Health System. That’s when he and his team offer a surgical fix.

Epilepsy surgery has come a long way, Dr. Oluigbo explains. When he first began practicing in the early 2000s, most surgeries were open, he says – they involved making a long incision in the scalp that can span half a foot or more. After drilling out a window of skull that can be as long as five inches, surgeons had to dig through healthy brain to find the abnormal tissue and remove it.

Each part of this “maximally invasive” procedure can be traumatic on a patient, Dr. Oluigbo says. That leads to significant pain after the procedure, extended hospital stays of at least a week followed by a long recovery. There are also significant risks for neurological complications including stroke, weakness, paralysis, speech problems and more.

However, open surgery isn’t the only option for epilepsy surgery anymore. Several new minimally invasive alternatives are now available to patients and the most promising, Dr. Oluigbo says, is called Visualase. He and his team are the only surgeons in the region who perform this procedure.

In Visualase surgeries, Dr. Oluigbo and his colleagues start by making a tiny incision, about 5 millimeters, on the scalp. Through this opening, they bore an even tinier hole into the skull and thread a needle inside that’s about 1.6 millimeters wide. “The brain barely notices that it’s there,” he says.

The tip of this wire holds a laser. Once this tip is placed directly at the seizure foci – the cluster of nerve cells responsible for generating a seizure – the patient is placed in an intraoperative magnetic resonance imaging (MRI) device. There, after checking the tip’s precise placement, the surgeons turn the laser on. Heat from the laser eradicates the foci, which the surgeons can see in real time using MRI thermography technology. The margins of the destroyed tissue are well-defined, largely sparing healthy tissue.

After the wire is removed, the incision is closed with a single stitch, and patients go home the next day. The majority of patients are seizure free, with rates as high as 90 percent for some types of epilepsy, Dr. Oluigbo says. Although seizure-free rates are also high for open procedures, he adds, Visualase spares them many of open surgeries’ painful and difficult consequences.

“Having done both open surgeries and Visualase,” Dr. Oluigbo says, “I can tell you the difference is night and day.”

Although open procedures will still be necessary for some patients with particularly large foci that are close to the surface, Dr. Oluigbo says that Visualase is ideal for treating medication-resistant cases in which the foci are buried deep within the brain. A typical example is a condition called hypothalamic hamartoma, in which tumors on the hypothalamus lead to gelastic seizures, an unusual seizure type characterized by uncontrollable laughing. He also uses Visualase for another condition called tuberous sclerosis, in which waxy growths called tubers develop in the brain, and for cancerous and benign brain tumors.

It’s gratifying to be able to help these children become seizure-free for the rest of their lives, says Dr. Oluigbo – even more so with the numerous updates he receives from families telling him how much this procedure has improved their children’s lifestyle.

“Visualase has completely changed the way that we approach these patients,” Dr. Oluigbo says. “It’s extraordinary to see the effects that this one procedure can have on the quality of life for patients here at Children’s National.”

Use of dietary supplements in children with Down syndrome

July 10, 2018

vitamins

There is a widespread practice of parents giving dietary supplements to children with Down syndrome in the hope of improving intelligence or function, according to new research published in The Journal of Pediatrics. The study, conducted by experts at Children’s National Rare Disease Institute (CNRDI), examined the prevalence, perceived impact, cost and other factors related to dietary supplement use in children with Down syndrome.

The survey finds nearly half of 1,167 respondents – 49 percent – have given or currently give dietary supplements to their children in an effort to improve health and development. On average, children receive three of the more than 150 supplements reported, with nearly 30 percent of users beginning supplementation before the child’s first birthday.

Amy Feldman Lewanda, M.D., a medical geneticist at CNRDI and lead author on the study, notes that the results also reveal a troubling trend – nearly 20 percent of parents who report using dietary supplements do not inform their pediatrician.

“While we know supplements are given by parents in hopes of improving developmental outcomes for children with Down syndrome, many of these supplements contain concerning ingredient profiles that can have adverse effects in infants and children that are too young to communicate their symptoms,” says Dr. Lewanda. “Additionally, these supplements have no proven safety or efficacy, so it’s important for families to consult with their pediatrician or primary care provider to help determine any risk, ill effects or conflicts with existing treatment.”

Reasons for not informing pediatricians about supplement use vary, according to the study results. The most common reason reported was that the doctor has never specifically asked about nutritional supplements. While some parents indicate they do not view supplement use as important medical information to divulge, others feel that their pediatrician may not be knowledgeable about these types of supplements or may dismiss the practice entirely, as some reportedly have done in the past.

Amy Feldman Lewanda, M.D., a medical geneticist at CNRDI and lead author on the study.

The most popular class of products reported by 25.8 percent of respondents taking supplements are antioxidants, such as curcumin, a byproduct of turmeric, and epigallocatechin-3-gallate (ECGC), the polyphenol compound in green tea. Vitamins, both single and multivitamins, rank second, accounting for 18.9 percent of supplement use. B vitamins were the most popular among single vitamin use. The third most popular supplement category, reported by 15.8 active or previous supplement users, contains proprietary products or combination supplements, such as Nutrivene-D or HAP-CAPS (High Achievement Potential Capsules).

According to Dr. Lewanda, chemical analyses of herbal supplements find some contain anabolic steroids or pharmaceuticals that aren’t listed in the ingredients. Hepatoxicity has been cited among 60 herbs, herbal drugs and herbal supplements. The problem, she notes, is that these products aren’t regulated, like pharmaceuticals are, and similarly, they aren’t thoroughly tested for their safety and efficacy.

The study also notes potential concerns about consuming hyper-concentrated forms of fat-soluble vitamins, including vitamin E and vitamin K, which stay in the body until the vitamins are used. One particular supplement, Speak, provides 5,000 percent of the recommended daily value limits of vitamin E. Fat-soluble vitamins and/or herbal supplements pose unknown health risks – including liver damage.

Among study respondents who actively provide supplements to their children, roughly 87 percent feel they are effective. Those who stopped administering supplements to their children cite lack of efficacy and cost – approximately $90.53 per month on average – as leading reasons for discontinuing use. Approximately 17 percent of respondents note side-effects of supplement use, specifically gastrointestinal disturbance, which was the most common side effect among active and previous supplement users.

“This research gives pediatricians a bit of a wake-up call on what’s trending in the Down syndrome community and the dialogue taking place online, in parent support groups and outside of the doctor’s office,” says Marshall Summar, M.D., director of CNRDI and co-author on the study. “The goal is for pediatricians and parents to work as a team in providing the best care possible for every child, so we hope this research provides physicians greater insight and encourages more open dialogue with patient families about supplement use. Since many of these supplements have active ingredients, it is vitally important that the primary care provider be aware of them.”

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