International study on fragile newborns challenges current practices
Clopidogrel in infants with systemic-to-pulmonary artery shunts
2013-06-21
(Press-News.org) Washington, DC – One of the largest clinical trials done in infants with congenital (present at birth) heart diseases, published in the New England Journal of Medicine, shows that the increasingly common practice of using the drug clopidogrel (Plavix®) to reduce shunt-related blood flow issues is not effective in the dose studied.
"Once again, pediatric-specific research shows that newborns and infants are not little adults," said David Wessel, MD, Chief Medical Officer, Children's National Medical Center, and lead author on the international study published in the June 20, 2013 issue of the New England Journal of Medicine. "The take away message for pediatric cardiac care providers is to reconsider use of Plavix® in certain cases. In pediatric medicine, the assumption is that smaller doses of a drug that works in adults will work in infants, but our study shows that this is not true for these young patients. For the parents of these fragile newborns, it is important to understand that research informs best practices, and they need to be informed advocates for their children."
Dr. Wessel discussed the study findings and implications for clinical care in a short video.
The objective of this international trial, which included more than 900 patients seen across 134 centers in 33 countries, was to evaluate the efficacy of Plavix® compared with placebo for the reduction of all-cause mortality and shunt-related morbidity in neonates and infants with cyanotic congenital heart disease palliated with systemic-to-pulmonary artery shunts. Many forms of congenital heart disease can be repaired in early infancy, and pulmonary blood flow with shunts is an important consideration during initial treatment that may include reconstructive heart surgery for defects in heart ventricles.
As the authors note, effective prevention for thrombosis (blood clots) in neonates and infants with these heart conditions had not been previously tested, although aspirin treatment was associated with significantly lower risk of mortality and shunt thrombosis in a separate registry developed before this trial. Preventive treatment in adult patients who develop clots in coronary arteries often combines aspirin and Plavix®. As happens with many drugs approved for use in adults, Plavix® use is spreading into pediatric practice without sound evidence, according to study authors. In fact, they continue, use of this drug has increased 15-fold from 2001 to 2009 in children's hospitals in the U.S.
This study showed no benefit from adding Plavix® to current treatment, which often includes aspirin. As noted in the study, the use of Plavix® to address thrombosis in newborns and infants being palliated with systemic-to-pulmonary artery shunts does not reduce all-cause mortality or shunt-related morbidity.
Further analysis (not part of the original trial design) supports the notion that aspirin alone may be effective at reducing the risk of clot formation in these infants. The study authors point out that the trial suggests that switching from aspirin alone to Plavix® alone at the dose studied is not a good idea.
"This is a good illustration of the successful collaboration between industry and academia to conduct clinical research in children under the written request process of FDA's Best Pharmaceuticals for Children Act (BPCA), noted Edward Connor, MD, MBE, Director of Innovation Development at Children's National and internationally recognized expert on drug development. "Studies of drugs in children are essential to inform child health care providers regarding safety and efficacy in this population. The need for data in newborns is especially important, given known developmental differences in this population compared to adults."
With the enactment of the Pediatric Provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, BPCA and the Pediatric Research Equity Act have become permanent, providing both requirements and incentives for the conduct of clinical trials in children. FDASIA recognizes the value of conducting studies in the neonates and enables FDA to add personnel with expertise in newborns. Incentives to manufacturers include patent extensions if a trial is properly designed, executed, and approved by the FDA.
Worldwide, heart defects are the most common congenital birth defect; tens of thousands of children are born with heart defects each year, and many of these defects can be treated with medications or with procedures, including reconstructive surgery or interventional catheterization.
The Clopidogrel to Lower Arterial Thrombotic Risk in Neonates and Infants Trial (CLARINET) was a double-blinded, randomized, placebo-controlled, parallel group, event driven trial. The study was sponsored by a collaboration between Sanofi-Aventis and Bristol-Myers Squibb.
###
Contacts: Paula Darte or Emily Hartman, Children's National Public Relations, 202-476-4500.
Children's National Medical Center
Children's National Medical Center in Washington, DC, has been serving the nation's children since 1870. Home to Children's Research Institute and the Sheikh Zayed Institute for Pediatric Surgical Innovation, Children's National is consistently ranked among the top pediatric hospitals by U.S.News & World Report and the Leapfrog Group. Children's National is a Magnet® designated hospital. With 303 beds and eight regional outpatient centers, Children's National is the premier provider of acute pediatric services in the Washington metropolitan area. For more information, visit ChildrensNational.org, or follow us on Facebook and Twitter.
END
ELSE PRESS RELEASES FROM THIS DATE:
2013-06-21
Picture two light beams intersecting one another in space. When the beams touch one another, does the light bend? Reflect? Combine into a single beam?
The answer, of course, is the light beams do nothing; they simply continue on their path. That is because in most media — including air, water, and vacuums — particles of quantized light beams called photons do not interact.
But in certain crystalline materials and with a powerful enough laser, it is possible to make photons interact with one another and take on a special set of characteristics. Known as nonlinear optical ...
2013-06-21
Mealybugs only eat plant sap, but sap doesn't contain all the essential amino acids the insects need to survive. Luckily, the bugs have a symbiotic relationship with two species of bacteria – one living inside the other in a situation unique to known biology – to manufacture the nutrients sap doesn't provide.
The net result: The bacteria get a comfy mealybug home, and the bugs get the nutrition they need to live.
University of Montana microbiologist John McCutcheon describes such mutually beneficial relationships used to solve life's little problems as "almost hilariously ...
2013-06-21
Scientists have discovered the survival secret to a genetic mutation that stokes leukemia cells, solving an evolutionary riddle and paving the way to a highly targeted therapy for leukemia. In a paper published today in Cell, researchers at NYU Langone Medical Center describe how a mutated protein, called Fbxw7, behaves differently when expressed in cancer cells versus healthy cells. "Fbxw7 is essential for making blood cells, so the big mystery is why a mutation on a gene so important for survival would persist," says lead author Iannis Aifantis, PhD, chair of pathology ...
2013-06-21
San Francisco, CA. (June 20, 2013) – Residents in anesthesiology training programs have high rates of burnout and depression, reports a survey study in the July issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS).
The findings raise concerns that, "In addition to effects on the health of anesthesiology trainees, burnout and depression may also affect patient care and safety," write Dr Gildasio S. de Oliveira, Jr, and colleagues of Northwestern University, Chicago.
Burnout and Depression Are Common in Anesthesia Trainees…
The ...
2013-06-21
San Francisco, CA. (June 20, 2013) – Retention of guidewires used to place central venous catheters (CVCs) is a complication that is considered always preventable—but nevertheless still happens, according to a report in the July issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS).
Dr Andrea Vannucci and colleagues report their hospital's experience of four patients with retained guidewires, and analyze risk factors for these rare, preventable medical errors. A pair of accompanying editorials support the need for more ...
2013-06-21
WASHINGTON —More than three-quarters (81.8 percent) of unscheduled admissions to the hospital now come through the emergency department, which is a sharp increase from the previous decade when only 64.5 percent of unscheduled admissions came through the ER. A study, published early online this week in the journal Medical Care, re-confirms recent findings by the RAND Corporation highlighting the growing role emergency physicians play in health care beyond the emergency department ("Changes in the Source of Unscheduled Hospitalizations in the United States").
"Although ...
2013-06-21
VIDEO:
This time-lapse movie shows a solar eruption that happened on June 7, 2011. At lower right, material blasts outward from the sun and then splashes down again, creating dramatic flashes...
Click here for more information.
On June 7, 2011, our Sun erupted, blasting tons of hot plasma into space. Some of that plasma splashed back down onto the Sun's surface, sparking bright flashes of ultraviolet light. This dramatic event may provide new insights into how young stars ...
2013-06-21
Since the discovery of the Van Allen radiation belts in in the Earth's upper atmosphere in 1958, space scientists have believed that these belts consisted of two doughnut-shaped rings of highly charged particles — an inner ring of high-energy electrons and energetic positive ions, and an outer ring of high-energy electrons.
However, in February of this year, a team of scientists reported in the journal Science the surprising discovery of a previously unknown third radiation ring. This narrow ring had briefly circled the Earth between the inner and outer rings in September ...
2013-06-21
A team of researchers from Texas and Colorado has identified a variety of factors that influence the likelihood of E. coli contamination of spinach on farms prior to harvest. Their research is published in the July 2013 issue of the journal Applied and Environmental Microbiology.
"Microbial contamination of produce seems strongly influenced by the time since the last irrigation, the workers' personal hygiene and the field's use prior to planting of produce," says first author Sangshin Park of Texas A&M University, College Station. "These factors, together with the role ...
2013-06-21
"Enhancing student engagement has been identified as the key to addressing problems of low achievement, high levels of student misbehavior, alienation, and high dropout rates." – Pitt professor Ming-Te Wang
PITTSBURGH—A student who shows up on time for school and listens respectfully in class might appear fully engaged to outside observers, including teachers. But other measures of student engagement, including the student's emotional and cognitive involvement with the course material, may tell a different story—one that could help teachers recognize students who are ...
LAST 30 PRESS RELEASES:
[Press-News.org] International study on fragile newborns challenges current practices
Clopidogrel in infants with systemic-to-pulmonary artery shunts
