The U.S. Department of Defense has awarded $2 million to Children’s National Hospital to study how a family of protease enzymes known as caspases may contribute to brain cell degeneration when activated by prolonged anesthesia and cardiopulmonary bypass during cardiac surgery for congenital heart disease.
This U.S. Army Medical Research Acquisition Activity Award, Anesthesia Neurotoxicity in Congenital Heart Disease, is led by principal investigator Nobuyuki Ishibashi, M.D., with both clinical and basic science co-investigators including Kazue Hashimoto-Torii, Ph.D., (Neuroscience), Richard Jonas, M.D., (Cardiovascular Surgery) and Nina Deutsch, M.D., (Anesthesiology).
While the specific cellular and molecular mechanisms of how anesthesia and cardiac surgery impact cortical development are poorly understood, both seem to impact brain growth and development in young children. The most common neurologic deficit seen in children after CHD surgical repair is the impairment of fine and gross motor skills.
Both anesthetic agents and inflammation like that seen as a result of cardiopulmonary bypass have also been shown to contribute to the activation of a specific group of enzymes that play an essential role in the routine (programmed) death of cells: caspases. However, recent pre-clinical research shows that these enzymes may also contribute to other alterations to cells beyond cell death, including making changes to other cell structures. In pre-clinical models, these changes cause impairments to fine and gross motor skills – the same neurological deficits seen in children with CHD who have undergone procedures requiring prolonged anesthesia and cardiopulmonary bypass.
The research team hypothesizes that caspases are extensively activated as a result of cardiac surgery and while that activation is rarely causing reduced numbers of neurons, the changes that caspase enzymes trigger in neurons are contributing to neurological deficits seen in children with CHD after surgery.
While the study focuses specifically on the impacts of cardiac surgery for correction of a heart defect, the findings could have major implications for any pediatric surgical procedure requiring prolonged anesthesia and/or cardiopulmonary bypass.
As medical data increasingly highlights the serious impact of COVID-19 on children’s health, the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces a special pitch competition focused on COVID-19-related pediatric medical devices that support home health monitoring and telehealth, and improve sustainability, resiliency and readiness in diagnosing and treating children during a pandemic.
The “Make Your Medical Device Pitch for Kids!” COVID19 edition 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. The finals in the virtual pitch event will be held on July 20, 2020. Winners will each receive a grant award of up to $50,000.
“Despite early reports that COVID-19 posed less of a threat to children, a recent study published by Children’s National shows that considerable numbers of pediatric patients are hospitalized and become critically ill from the disease,” said Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. “Innovation in children’s medical devices consistently lags behind that of adults and we need to change that if we are to confront the challenge to children’s health of COVID-19 and future pandemics.”
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.
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.
Submissions for the competition are being accepted now through Monday, July 6, 2020z at the NCC-PDI website, Innovate4Kids.org, where complete details can be found.
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 progress of adult medical devices. Along with Children’s National, University of Maryland and Medtech Innovator, NCC-PDI members include accelerator BioHealth Innovation and design firm Archimedic.
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. The consortium hosts a major pediatric pitch competition annually that showcases and awards promising pediatric innovations and provides a first-of-its-kind pediatric-focused accelerator program for finalists.
Children’s National Hospital in Washington, D.C., was ranked No. 7 nationally in the U.S. News & World Report 2020-21 Best Children’s Hospitals annual rankings. This marks the fourth straight year Children’s National has made the list, which ranks the top 10 children’s hospitals nationwide.
In addition, its neonatology program, which provides newborn intensive care, ranked No.1 among all children’s hospitals for the fourth year in a row.
For the tenth straight year, Children’s National also ranked in all 10 specialty services, with seven specialties ranked in the top 10.
“Our number one goal is to provide the best care possible to children. Being recognized by U.S. News as one of the best hospitals reflects the strength that comes from putting children and their families first, and we are truly honored,” says Kurt Newman, M.D., president and CEO of Children’s National Hospital.
“This year, the news is especially meaningful, because our teams — like those at hospitals across the country — faced enormous challenges and worked heroically through a global pandemic to deliver excellent care.”
“Even in the midst of a pandemic, children have healthcare needs ranging from routine vaccinations to life-saving surgery and chemotherapy,” said Ben Harder, managing editor and chief of Health Analysis at U.S. News. “The Best Children’s Hospitals rankings are designed to help parents find quality medical care for a sick child and inform families’ conversations with pediatricians.”
The annual rankings are the most comprehensive source of quality-related information on U.S. pediatric hospitals. The rankings recognize the nation’s top 50 pediatric hospitals based on a scoring system developed by U.S. News. The top 10 scorers are awarded a distinction called the Honor Roll.
The bulk of the score for each specialty service is based on quality and outcomes data. The process includes a survey of relevant specialists across the country, who are asked to list hospitals they believe provide the best care for patients with the most complex conditions.
Below are links to the seven Children’s National specialty services that U.S. News ranked in the top 10 nationally:
- Neonatology (No. 1), led by Division Chief Billie Lou Short, M.D.
- Neurology and Neurosurgery (No. 3), led by Division Chiefs William D. Gaillard, M.D., and Robert F. Keating, M.D.
- Cancer (No. 6), led by Division Chief Jeffrey S. Dome, M.D., Ph.D.
- Nephrology (No. 7), led by Division Chief Marva Moxey-Mims, M.D., FASN
- Orthopedics (No. 9), led by Division Chief Matthew Oetgen, M.D., MBA
- Pulmonology and Lung Surgery (No.9), led by Division Chief Anastassios Koumbourlis, M.D., MPH
- Diabetes and Endocrinology (No. 10), led by Division Chief Andrew Dauber, M.D., MMSC
Many of the neurological deficits seen in children with congenital heart disease (CHD) are related to abnormal white matter development early in life caused by reduced oxygen supply to the brain while in utero. Children with immature white matter at birth also commonly sustain additional white matter injuries following cardiac surgery.
The NIH recently awarded a prestigious R01 grant totaling more than $3.2 million to a collaborative project led by the Center for Neuroscience Research, the Sheikh Zayed Institute for Pediatric Surgical Innovation and the Children’s National Heart Institute at Children’s National Hospital as well as MedStar Washington Hospital Center.
The research, titled “White matter protection in the fetus with congenital heart disease,” looks specifically at whether providing a supplemental amount of the naturally occurring tetrahydrobiopterin (BH4) for pregnant women could rescue white matter development of fetuses with congenital heart disease whose brains aren’t receiving enough oxygen – or suffering from hypoxic-ischemic events.
Previous preclinical studies have shown that this lack of oxygen depletes the brain’s natural BH4 level, and the researchers hypothesize that BH4 levels play a critical role in the growth and development of white matter in the fetal brain by triggering key cellular/molecular processes. Specifically, the study will focus on three aims:
- Establish in a preclinical model the optimal protective regiment for women pregnant with a fetus who has CHD to receive BH4.
- Determine the appropriate approach to deliver BH4 to this population
- Leverage genetic tools and biochemical techniques in the laboratory to better understand where and how BH4 levels play a role in the growth (or lack thereof) of oligodendrocytes—the primary cells of white matter.
This laboratory-based work is the first step to determining if the neurodevelopment of babies born with CHD can be preserved or recovered by addressing key brain development that occurs before the baby is even born. Findings related to congenital heart disease may also translate to other populations where white matter development is affected by hypoxia-ischemia, including premature infants.
The project is led by principal investigator Nobuyuki Ishibashi, M.D., with co-investigators Vittorio Gallo, Ph.D., Joseph Scafidi, D.O., and Mary Donofrio, M.D. as well as colleagues at MedStar Washington Hospital Center.
A prospective randomized controlled trial has given pediatric colorectal specialists the first evidence to reconsider a standard postoperative care practice: Routine anal dilations following a primary posterior sagittal anorectoplasty (PSARP), an operation to reconstruct a child born with imperforate anus. This treatment has been the standard of care following PSARP for more than thirty years and was believed to help prevent strictures after surgery for anorectal malformations (imperforate anus). However, it requires parents and caregivers to perform this uncomfortable procedure on their child daily, which can have a significant psychological impact on the child. Prior to this trial, a quality of life assessment found that postoperative dilations were the most stressful part of these patients’ care for both patient and parents.
“The PSARP procedure, performed for the first time in 1980, improves the lives of children born with imperforate anus by providing a safe and effective reconstruction technique,” says Marc Levitt, M.D., who led the study with co-author Richard Wood, M.D., of Nationwide Children’s Hospital, before joining Children’s National Hospital as chief of the division of Colorectal and Pelvic Reconstructive Surgery. “We are thrilled to have evidence that one of the top postoperative challenges for parents – a twice daily anal dilation for several months after the surgery is completed – can potentially be eliminated for most kids with no impact on their recovery.”
“We also found that if a stricture, or scar, develops, which occurs in only about 10 percent of cases, it can easily be managed with a minor operative procedure done at the same time as colostomy closure, which in most cases they already need. So, if a family had to choose between daily dilations for months or a one in 10 risk of needing a minor surgical procedure, they can now make that choice and avoid routine dilations.”
The prospective single institution randomized controlled trial was conducted between 2017 and 2019 and included 49 patients. The abstract of the results was accepted for presentation at the British Association of Paediatric Surgeons Annual International Congress, 2020, and its manuscript is to be published.
“The clinical benefit of routine dilation had never been studied in a formal way, it had been accepted as surgical dogma. Our cohort, who underwent a randomized controlled trial, gave us the ability to look at this practice in an evidence-based way,” Dr. Levitt says. “Revising this practice could be a real game-changer for parents and kids with anorectal malformations.”
Pediatric orthopaedic surgery as a field is focused on improving quality and value in pediatric spine surgery, especially when it comes to eliminating surgical site infections (SSI). Many studies have documented how and why surgical site infections occur in pediatric spinal fusion patients, however, there is very little data about what approaches are most effective at reducing SSIs for these patients in a sustainable way.
At the Pediatric Orthopaedic Society of North America’s 2020 Annual Meeting, Matthew Oetgen, M.D., MBA, chief of orthopaedic surgery and sports medicine at Children’s National Hospital, presented findings from a long-term single institution study of acute SSI prevention measures.
“These findings give us specific insight into the tactics that are truly preventing, and in our case sometimes even eliminating, SSIs for pediatric scoliosis surgery,” says Dr. Oetgen, who also served on the annual meeting program committee. “By analyzing patient records across more than a decade, we were able to see that some strategies are quite effective, and others, that we thought would move the needle, just don’t.”
The team reviewed medical records and radiographs dating back to 2008 for 1,195 patients who had spinal fusion for scoliosis, including idiopathic scoliosis as well as other forms such as neuromuscular or syndromic scoliosis. Over that period of time, the division of orthopaedics and sports medicine at Children’s National was collaborating with the hospital’s infection control team to achieve several programmatic implementation milestones, including:
- January 2012: Standardized infection surveillance program
- July 2013: Standardized perioperative infection control protocols including those for pre-operative surgical site wash, surgical site preparation and administration of antibiotics before and after surgery
- March 2015: Standardized comprehensive spinal care pathway including protocols for patient temperature control, fluid and blood management, and drain and catheter management
Over the study time period, the team found that SSIs did decrease, but interestingly, the rate did not progressively decrease with each subsequent intervention.
“Instead, we found that the rate went down and was even eliminated for some subgroups when the perioperative infection control protocols were implemented in 2013 and sustained through the study period end,” says Dr. Oetgen. “The other programmatic efforts that started in 2012 and 2015 had no impact on infection rates.”
He also notes that the study’s findings have identified a crucial component in the process for infection control in pediatric spinal surgery—perioperative protocols. “A relatively uncomplicated perioperative infection control protocol did the best job decreasing SSI in spinal fusion. Future efforts to optimize this particular protocol may help improve the rates even further.”
POSNA’s Annual Meeting content, including Dr. Oetgen’s presentation, is available from May 13, 2020 through December 31, 2020.
The Children’s National Research Institute recently released its 2019-2020 academic annual report, titled 150 Years Stronger Through Discovery and Care to mark the hospital’s 150th birthday. Not only does the annual report give an overview of the institute’s research and education efforts, but it also gives a peek in to how the institute has mobilized to address the coronavirus pandemic.
“Our inaugural research program in 1947 began with a budget of less than $10,000 for the study of polio — a pressing health problem for Washington’s children at the time and a pandemic that many of us remember from our own childhoods,” says Vittorio Gallo, Ph.D., chief research officer at Children’s National Hospital and scientific director at Children’s National Research Institute. “Today, our research portfolio has grown to more than $75 million, and our 314 research faculty and their staff are dedicated to finding answers to many of the health challenges in childhood.”
Highlights from the Children’s National Research Institute annual report
- In 2018, Children’s National began construction of its new Research & Innovation Campus (CNRIC) on 12 acres of land transferred by the U.S. Army as part of the decommissioning of the former Walter Reed Army Medical Center campus. In 2020, construction on the CNRIC will be complete, and in 2012, the Children’s National Research Institute will begin to transition to the campus.
- In late 2019, a team of scientists led by Eric Vilain, M.D., Ph.D., director of the Center for Genetic Medicine Research, traveled to the Democratic Republic of Congo to collect samples from 60 individuals that will form the basis of a new reference genome data set. The researchers hope their project will generate better reference genome data for diverse populations, starting with those of Central African descent.
- A gift of $5.7 million received by the Center for Translational Research’s director, Lisa Guay-Woodford, M.D., will reinforce close collaboration between research and clinical care to improve the care and treatment of children with polycystic kidney disease and other inherited renal disorders.
- The Center for Neuroscience Research’s integration into the infrastructure of Children’s National Hospital has created a unique set of opportunities for scientists and clinicians to work together on pressing problems in children’s health.
- Children’s National and the National Institute of Allergy and Infectious Diseases are tackling pediatric research across three main areas of mutual interest: primary immune deficiencies, food allergies and post-Lyme disease syndrome. Their shared goal is to conduct clinical and translational research that improves what we know about those conditions and how we care for children who have them.
- An immunotherapy trial has allowed a little boy to be a kid again. In the two years since he received cellular immunotherapy, Matthew has shown no signs of a returning tumor — the longest span of time he’s been tumor-free since age 3.
- In the past 6 years, the 104 device projects that came through the National Capital Consortium for Pediatric Device Innovation accelerator program raised $148,680,256 in follow-on funding.
- Even though he’s watched more than 500 aspiring physicians pass through the Children’s National pediatric residency program, program director Dewesh Agrawal, M.D., still gets teary at every graduation.
Understanding and treating the novel coronavirus (COVID-19)
In a short period of time, Children’s National Research Institute has mobilized its scientists to address COVID-19, focusing on understanding the virus and advancing solutions to ameliorate the impact today and for future generations. Children’s National Research Institute Director Mark Batshaw, M.D., highlighted some of these efforts in the annual report:
- Eric Vilain, M.D., Ph.D., director of the Center for Genetic Medicine Research, is looking at whether or not the microbiome of bacteria in the human nasal tract acts as a defensive shield against COVID-19.
- Catherine Bollard, M.D., MBChB, director of the Center for Cancer and Immunology Research, and her team are seeing if they can “train” T cells to attack the invading coronavirus.
- Sarah Mulkey, M.D., Ph.D., an investigator in the Center for Neuroscience Research and the Fetal Medicine Institute, is studying the effects of, and possible interventions for, coronavirus on the developing brain.
You can view the entire Children’s National Research Institute academic annual report online.
In early March as countries around the globe began to wrestle with how best to tackle the spread of COVID-19, a group of doctors, nurses, researchers and other medical staff from Children’s National Hospital were wrestling with a distinct set of challenges: What to do about the 10 Ugandan children and adults who were currently scheduled for lifesaving heart surgery (and the countless others who would benefit from the continued training of the local heart surgery team) to correct complications of rheumatic heart disease (RHD) during an impending medical mission in the country.
Rheumatic heart disease impacts over 39 million people globally and causes nearly 300,000 deaths per year. RHD is the result of frequent, untreated streptococcal throat infections in childhood that ultimately cause the body’s immune system to repeatedly damage heart valves. It is completely preventable, yet the majority of the world’s children still live in impoverished and overcrowded conditions that predispose them to RHD. Most patients present with advanced valvular heart disease. For example, in Uganda, an RHD registry includes over 600 children with clinical RHD, of which nearly 40% die within four years and the median survival time from enrollment in the registry is only nine months. For these patients, heart surgery is the only viable solution for long-term survival and normal quality of life.
The scheduled trip from Washington was part of a nearly 20-year partnership** between doctors, nurses, researchers and other medical staff in the United States, including Craig Sable, M.D., associate chief of cardiology, and and Pranava Sinha, M.D.,pediatric cardiovascular surgeon, at Children’s National Hospital in Washington, D.C., and the Uganda Heart Institute in Kampala, Uganda. The partnership aims to tackle RHD head-on. It provides surgical skill transfer, allows for treatment of more complex patients, and increases sustainable surgical capacity for Uganda’s RHD patients over time. As a result, over the last 15 years more than 1,000 children have received lifesaving heart surgery in Uganda, with the Uganda Heart Institute (UHI) performing one to two heart valve surgeries every two weeks over the last few years.
COVID-19 was changing the current plan, however. Travel between countries was limited, and the team from the U.S. wouldn’t have been permitted to leave the U.S. and return according to schedule. The trip, and the support teams who were scheduled to arrive to help with the surgeries, were cancelled. The U.S. team members who had already arrived in Uganda were sent home after helping their UHI colleagues set up and prepare for the surgeries as much as possible. Knowing that patients and families were counting on the surgery mission to go forward after waiting for months or years to have surgery for heart valve disease, UHI decided not to cancel the majority of the surgeries. Instead, for the first time, they planned and successfully completed five valve-related cases in a single week – several of them quite complex. The cardiologists and cardiac surgeons from Children’s National who were supposed to be in-country for these procedures were forced to limit their in person assistance to the set-up activities the week prior to surgery and telehealth consult during the procedures.
“It was hard not to be able to stay and work with the UHI team to help these families,” says Dr. Sable. “But we are so proud of the UHI team for meeting this challenge on their own. We knew they had the skills to perform at this volume and complexity. It’s a proud moment to see the team accomplish this major milestone, and to see the patients they cared for thrive.”
The patients are the most important outcome: The five who had successful open-heart surgery are all doing well, either on their way to recovery or already discharged to their communities, where they will, for the first time in memory, be able to play, exercise and go to school or work.
Longer term, this success demonstrates the UHI medical team’s ability to manage greater surgical capacity even when surgical missions from the U.S. resume. The partnership’s goal is to complete at least 1,000 annual operations (both pediatric and adult), with the majority being performed by the local team. Having this capacity available will mean the difference between life and death for many children and adults who have RHD in Uganda and the surrounding countries.
**This work is supported by the Edwards Life Sciences/Thoracic Surgery Foundation, the Emirates Airline Foundation, Samaritan’s Purse Children’s Heart Project and Gift of Life International.
Children’s National Hospital announced that world-class surgeon Yves d’Udekem, M.D., Ph.D., will become the next Chief of Cardiac Surgery and Co-Director of the Children’s National Heart Institute this summer.
Dr. d’Udekem is Belgian-born with Canadian and Australian citizenship and received his early training in Belgium and Toronto. As an attending cardiac surgeon in Belgium, he operated on both adults and children with congenital heart disease. Dr. d’Udekem then worked with internationally recognized heart surgeon Marc de Laval, M.D., FRCS, and others in London to train in congenital heart surgery at the Great Ormond Street Hospital for Children.
From there, he was recruited to The Royal Children’s Hospital in Melbourne, Australia, an institution that has been a leader in advancing the field of congenital heart disease. In Melbourne, Dr. d’Udekem built an outstanding reputation for clinical excellence and an exceptional academic career. He has over 300 publications and is highly cited and respected. Dr. d’Udekem obtained more than $7 million in grant funding over the past five years as the creator and leader of the highly touted Fontan Registry.
The Children’s National Cardiology team and hospital leadership have built a framework for Dr. d’Udekem to succeed and advance the legacy that has been so successfully created in cardiac surgery by Richard Jonas, M.D. Dr. Jonas is a world leader in congenital heart surgery who made significant clinical and academic advances in the field and will continue his award-winning research career at Children’s National in the laboratory focusing on neurodevelopmental outcomes for children with heart disease.
Children’s National offers a comprehensive surgical program that includes a team of experienced surgeons performing the full range of procedures available for treatment of pediatric cardiac disease and congenital heart defects. The high volume program serves neonates through adults with congenital heart disease with particular attention to neurodevelopmental outcomes.
A new LinkedIn post from Kurt Newman, M.D., president and CEO of Children’s National Hospital, tells a story about the hospital’s cardiac surgeons and interventional cardiologists working with the U.S. Food and Drug Administration (FDA) to bring a better-sized, less-invasive vascular stent to the U.S. for the first time. The stent holds open a newborn’s ductus arteriosus, a key blood vessel that keeps blood flowing to the body, until the baby is big and strong enough to undergo a serious open-heart procedure for repair of hypoplastic left heart syndrome.
He writes, “Why is this important? At less than 6 lbs., these patients have arteries that are thinner than a toothpick – less than 2mm in diameter. Currently, the stent used in these children is an FDA approved device for adult vascular procedures, adapted and used off-label in children. It is not always well suited for the smallest babies as it is too large for insertion through the artery and often too long as well. The extra length can create immediate and long-term complications including obstructing the vessel it is supposed to keep open.
“While I am proud of the talent and dedication of our Children’s National cardiac surgery and interventional cardiology teams, I tell this story to illustrate a larger point – innovation in children’s medical devices matters. What’s unfortunate is that development and commercialization of pediatric medical devices in the U.S. continues to lag significantly behind adults…We can and must do better.”
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.
The American Cleft Palate-Craniofacial Association (ACPA) recognized Albert Oh, M.D., with the 2020 Emerging Leader Award. This award is given to professionals who have been members of ACPA between three to 15 years, and who exhibit exemplary accomplishments and dedication to the issues affecting people with cleft and craniofacial conditions.
The ACPA is an association consisting of professionals who treat and/or perform research on cleft and craniofacial conditions. The nonprofit organization also supports those affected through education and resources through its ACPA Family Services program.
As the director of the Cleft and Craniofacial Program at Children’s National Hospital, Dr. Oh is a leader in the research, surgical treatment and holistic care of cleft and craniofacial patients. He has published over 75 peer-reviewed scientific articles and book chapters. Dr. Oh’s current research interests include the outcomes and safety of cleft and craniofacial procedures, 3-D analysis of craniofacial morphology, Pierre Robin sequence and vascular anomalies.
Dr. Oh says that “It is an honor to be recognized by the ACPA and to share their mission of advancing research and improving outcomes for all those affected by cleft and craniofacial conditions.”
Dr. Oh will be presented with his award during the ACPA’s 77th Annual Meeting in Portland, Or.
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.
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.
Children’s National Hospital and Virginia Tech create formal partnership that includes the launch of a Virginia Tech biomedical research facility within the new Children’s National Research & Innovation Campus.
Children’s National Hospital and Virginia Tech recently announced a formal partnership that will include the launch of a 12,000-square-foot Virginia Tech biomedical research facility within the new Children’s National Research & Innovation Campus. The campus is an expansion of Children’s National that is located on a nearly 12-acre portion of the former Walter Reed Army Medical Center in Washington, D.C. and is set to open its first phase in December 2020. This new collaboration brings together Virginia Tech, a top tier academic research institution, with Children’s National, a U.S. News and World Report top 10 children’s hospital, on what will be the nation’s first innovation campus focused on pediatric research.
“Virginia Tech is an ideal partner to help us deliver on what we promised for the Children’s National Research & Innovation Campus – an ecosystem that enables us to accelerate the translation of potential breakthrough discoveries into new treatments and technologies,” says Kurt Newman, M.D., president and CEO, Children’s National. “Our clinical expertise combined with Virginia Tech’s leadership in engineering and technology, and its growing emphasis on biomedical research, will be a significant advance in developing much needed treatment and cures to save children’s lives.”
Earlier this year, Children’s National announced a collaboration with Johnson & Johnson Innovation LLC to launch JLABS @ Washington, DC at the Research & Innovation Campus. The JLABS @ Washington, DC site will be open to pharmaceutical, medical device, consumer and health technology companies that are aiming to advance the development of new drugs, medical devices, precision diagnostics and health technologies, including applications in pediatrics.
“We are proud to welcome Virginia Tech to our historic Walter Reed campus – a campus that is shaping up to host some of the top minds, talent and innovation incubators in the world,” says Washington, D.C. Mayor Muriel Bowser. “The new Children’s National Research & Innovation Campus will exemplify why D.C. is the capital of inclusive innovation – because we are a city committed to building the public and private partnerships necessary to drive discoveries, create jobs, promote economic growth and keep D.C. at the forefront of innovation and change.”
Faculty from the Children’s National Research Institute and the Fralin Biomedical Research Institute at Virginia Tech Carilion (VTC) have worked together for more than a decade, already resulting in shared research grants, collaborative publications and shared intellectual property. Together, the two institutions will now expand their collaborations to develop new drugs, medical devices, software applications and other novel treatments for cancer, rare diseases and other disorders.
“Joining with Children’s National in the nation’s capital positions Virginia Tech to improve the health and well-being of infants and children around the world,” says Virginia Tech President Tim Sands, Ph.D. “This partnership resonates with our land-grant mission to solve big problems and create new opportunities in Virginia and D.C. through education, technology and research.”
The partnership with Children’s National adds to Virginia Tech’s growing footprint in the Washington D.C. region, which includes plans for a new graduate campus in Alexandria, Va. with a human-centered approach to technological innovation. Sands said the proximity of the two locations – just across the Potomac – will enable researchers to leverage resources, and will also create opportunities with the Virginia Tech campus in Blacksburg, Va. and the Virginia Tech Carilion Health Science and Technology campus in Roanoke, Va.
Carilion Clinic and Children’s National have an existing collaboration for provision of certain specialized pediatric clinical services. The more formalized partnership between Virginia Tech and Children’s National will drive the already strong Virginia Tech-Carilion Clinic partnership, particularly for children’s health initiatives and facilitate collaborations between all three institutions in the pediatric research and clinical service domains.
Children’s National and Virginia Tech will engage in joint faculty recruiting, joint intellectual property, joint training of students and fellows, and collaborative research projects and programs according to Michael Friedlander, Ph.D., Virginia Tech’s vice president for health sciences and technology, and executive director of the Fralin Biomedical Research Institute at VTC.
“The expansion and formalization of our partnership with Children’s National is extremely timely and vital for pediatric research innovation and for translating these innovations into practice to prevent, treat and ultimately cure nervous system cancer in children,” says Friedlander, who has collaborated with Children’s National leaders and researchers for more than 20 years. “Both Virginia Tech and Children’s National have similar values and cultures with a firm commitment to discovery and innovation in the service of society.”
“Brain and other nervous system cancers are among the most common cancers in children (alongside leukemia),” says Friedlander. “With our strength in neurobiology including adult brain cancer research in both humans and companion animals at Virginia Tech and the strength of Children’s National research in pediatric cancer, developmental neuroscience and intellectual disabilities, this is a perfect match.”
The design of the Children’s National Research & Innovation Campus not only makes it conducive for the hospital to strengthen its prestigious partnerships with Virginia Tech and Johnson & Johnson, it also fosters synergies with federal agencies like the Biomedical Advanced Research and Development Authority, which will collaborate with JLABS @ Washington, DC to establish a specialized innovation zone to develop responses to health security threats. As more partners sign on, this convergence of key public and private institutions will accelerate discoveries and bring them to market faster for the benefit of children and adults.
“The Children’s National Research & Innovation Campus pairs an inspirational mission to find new treatments for childhood illness and disease with the ideal environment for early stage companies. I am confident the campus will be a magnet for big ideas and will be an economic boost for Washington DC and the region,” says Jeff Zients, who was appointed chair of the Children’s National Board of Directors effective October 1, 2019. As a CEO and the former director of President Obama’s National Economic Council, Zients says that “When you bring together business, academia, health care and government in the right setting, you create a hotbed for innovation.”
Ranked 7th in National Institutes of Health research funding among pediatric hospitals, Children’s National continues to foster collaborations as it prepares to open its first 158,000-square-foot phase of its Research & Innovation Campus. These key partnerships will enable the hospital to fulfill its mission of keeping children top of mind for healthcare innovation and research while also contributing to Washington D.C.’s thriving innovation economy.
A poster at the AHA Scientific Sessions suggests bisphenol-s (BPS) and bisphenol-f (BPF) may have less impact on heart function than bisphenol-a (BPA).
Some chemical alternatives to plastic bisphenol-a (BPA), which is still commonly used in medical settings such as operating rooms and intensive care units, may be less disruptive to heart electrical function than BPA, according to a pre-clinical study that explored how the structural analogues bisphenol-s (BPS) and bisphenol-f (BPF) interact with the chemical and electrical functions of heart cells.
The findings suggest that in terms of toxicity for heart function, these chemicals that are similar in structure to BPA may actually be safer for medically fragile heart cells, such as those in children with congenital heart disease. Previous research has found a high likelihood that BPA exposure may impact the heart’s electrical conductivity and disrupt heart rhythm, and patients are often exposed to the plastic via clinical equipment found in intensive care and in the operating room.
“There are still many questions that need to be answered about the safety and efficacy of using chemicals that look and act like BPA in medical settings, especially in terms of their potential contribution to endocrine disruption,” says Nikki Gillum Posnack, Ph.D., the poster’s senior author and a principal investigator in the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital. “What we can say is that, in this initial pre-clinical investigation, it appears that these structural analogues have less of an impact on the electrical activity within the heart and therefore, may be less likely to contribute to dysrhythmias.”
Future studies will seek to quantify the risk that these alternative chemicals pose in vulnerable populations, including pediatric cardiology and cardiac surgery patients. Since pediatric patients’ hearts are still growing and developing, the interactions may be different than what was seen in this pilot study.
Learn more the impacts of exposure to plastics such as bisphenol-A and plasticizers such as DEHP and MEHP that are commonly used in medical devices:
- Plasticizer interaction with the heart
- What are the health effects of plastics?
- Do plastic chemicals contribute to the sudden death of patients on dialysis?
- Examining BPA’s impact on developing heart cells
- Experimental model study links phthalates and cardiovascular health
Bisphenol-a Analogues May Be Safer Alternatives For Plastic Medical Products
Rafael Jaimes, Damon McCullough, Luther M Swift, Marissa Reilly, Morgan Burke, Jiansong Sheng, Javier Saiz, Nikki G Posnack
Poster Presentation by senior author Nikki G Posnack
CH.APS.01 – Translational Research in Congenital Heart Disease
AHA Scientific Sessions
November 16, 2019
1:30 p.m. – 2:00 p.m.
An upcoming clinical trial at Children’s National Hospital will harness cardiopulmonary bypass as a delivery mechanism for a novel intervention designed to stimulate brain growth and repair in children who undergo cardiac surgery for congenital heart disease (CHD).
The NIH has awarded Children’s National $2.5 million to test the hypothesis that mesenchymal stromal cells (MSCs), which have been shown to possess regenerative properties and the ability to modulate immune responses in a variety of diseases, collected from allogeneic bone marrow, may promote regeneration of damaged neuronal and glial cells in the early postnatal brain. If successful, the trial will determine the safety of the proposed treatment in humans and set the stage for a Phase 2 efficacy trial of what could potentially be the first treatment for delays in brain development that happen before birth as a consequence of congenital heart disease. The study is a single-center collaboration between three Children’s National physician-researchers: Richard Jonas, M.D., Catherine Bollard, M.B.Ch.B., M.D. and Nobuyuki Ishibashi, M.D.
Dr. Jonas, chief of cardiac surgery at Children’s National, will outline the trial and its aims on Monday, November 18, 2019, at the American Heart Association’s Scientific Sessions 2019. Dr. Jonas was recently recognized by the Cardiac Neurodevelopmental Outcome Collaborative for his lifelong research of how cardiac surgery impacts brain growth and development in children with CHD.
Read more about the study: Researchers receive $2.5M grant to optimize brain development in babies with CHD.
Regenerative Cell Therapy in Congenital Heart Disease – Protecting the Immature Brain
Presented by Richard Jonas, M.D.
AHA Scientific Sessions
Session CH.CVS.608 Congenital Heart Disease and Pediatric Cardiology Seminar: A Personalized Approach to Heart Disease in Children
9:50 a.m. to 10:05 a.m.
November 18, 2019
Adolescents and teens experience biliary side effects after weight-loss surgery at about the same rate as adults. However, in younger patients, the symptoms are more likely to manifest as pancreatic inflammation, or acute pancreatitis, according to a new study published in the November issue of the journal Obesity.
“Biliary issues after laparoscopic sleeve gastrectomy occur with about the same frequency in pediatric patients as they do in adults,” says Evan Nadler, M.D., senior author on the study and director of the Bariatric Surgery Program at Children’s National Hospital. “We were surprised, however, to find that the small number of pediatric patients who do experience these complications seem to be more likely to have acute pancreatitis as a result. In adults, it’s more commonly the gall bladder that acts up as opposed to the pancreas.”
The study included 309 patients without previous or concurrent history of biliary disease or gallstones who had undergone laparoscopic sleeve gastrectomy at Children’s National. Twenty-one patients, or 6.7% of the cohort, were diagnosed with biliary disease after surgery. Sixty-two percent of the pediatric patients with biliary disease also showed signs of acute pancreatitis, while only one-third of those with post-operative biliary disease presented with a gallstone blockage, or biliary colic. In adults, biliary colic is a primary symptom after surgery and far fewer adults experience acute pancreatitis.
“We definitely need more research, across a more diverse population, to understand the mechanisms behind this higher likelihood of acute pancreatitis in pediatric patients. More importantly, this study provides a proof point that weight-loss surgery doesn’t pose any higher risk of biliary complications for kids than it does for adults.”
Obesity’s editorial team selected the study as one of the Top 5 most innovative scientific research studies to prevent and treat obesity in 2019. It appears in a special section of the November 2019 print edition. Dr. Nadler will present his findings during the Obesity Journal Symposium on Nov. 5, 2019, as part of ObesityWeek®, the annual meeting of The Obesity Society.
“We’ve got one of the largest, if not the largest, weight-loss surgery programs dedicated solely to caring for children and adolescents,” adds Dr. Nadler. “That gives us a unique ability to collect and analyze a statistically significant sample of pediatric-specific patient data and really contribute a better understanding of how bariatric surgery specifically impacts younger patients.”
In late October 2019, the American Academy of Pediatrics issued guidance with the aim of providing severely obese teens easier access to bariatric surgery.
“Our study is just the latest contribution to a significant body of evidence that weight-loss surgery should be considered a viable treatment approach for children and teenagers with severe obesity, an idea that is now endorsed by the nation’s largest organization of pediatricians,” he points out.
The Obesity Journal Symposium occurs on Tuesday, Nov. 5, 2019, from 3:30 – 5:00 p.m. at the Mandalay Bay South Convention Center in Las Vegas, Nev. ObesityWeek® is a partnership of The Obesity Society and the American Society for Metabolic and Bariatric Surgery.
Presentation: Pattern of Biliary Disease Following Laparoscopic Sleeve Gastrectomy in Adolescents
Session: Obesity Journal Symposium
Date/Time: 11/5/2019, 3:30 pm – 5:00 pm
Co-authors: Jun Tashiro , Arunachalam A. Thenappan, and Evan P. Nadler
Richard Jonas, M.D., is this year’s recipient of the Newburger-Bellinger Cardiac Neurodevelopmental Award in recognition of his lifelong research into understanding the impact of cardiac surgery on the growth and development of the brain. The award was established in 2013 by the Cardiac Neurodevelopmental Outcome Collaborative (CNOC) to honor Jane Newburger and David Bellinger, pioneers in research designed to understand and improve neurodevelopmental outcomes for children with heart disease.
At Children’s National, Dr. Jonas’ laboratory studies of neuroprotection have been conducted in conjunction with Dr. Vittorio Gallo, director of neuroscience research at Children’s National, and Dr. Nobuyuki Ishibashi, director of the cardiac surgery research laboratory. Their NIH-supported studies have investigated the impact of congenital heart disease and cardiopulmonary bypass on the development of the brain, with particular focus on impacts to white matter, in people with congenital heart disease.
Dr. Jonas’s focus on neurodevelopment after cardiac surgery has spanned his entire career in medicine, starting with early studies in the Harvard psychology department where he developed models of ischemic brain injury. He subsequently undertook a series of highly productive pre-clinical cardiopulmonary bypass studies at the National Magnet Laboratory at MIT. These studies suggested that some of the bypass techniques used at the time were suboptimal. The findings helped spur a series of retrospective clinical studies and subsequently several prospective randomized clinical trials at Boston Children’s Hospital examining the neurodevelopmental consequences of various bypass techniques. These studies were conducted by Dr. Jonas and others, in collaboration with Dr. Jane Newburger and Dr. David Bellinger, for whom this award is named.
Dr. Jonas has been the chief of cardiac surgery and co-director of the Children’s National Heart Institute since 2004. He previously spent 20 years on staff at Children’s Hospital Boston including 10 years as department chief and as the William E. Ladd Chair of Surgery at Harvard Medical School.
As the recipient of the 2019 award, Dr. Jonas will deliver a keynote address at the 8th Annual Scientific Sessions of the Cardiac Neurodevelopmental Outcome Collaborative in Toronto, Ontario, October 11-13, 2019.
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