We strive, through our clinical trials research, to bring new treatment options to our pediatric and adult patients. We are focused on medical advancements for preventing allergy symptoms and in improving outcomes of asthma, hay fever and eczema. We serve as principal investigators on Phase II and Phase III studies testing promising new compounds for asthma and allergies. We are also currently working on a study to look at compounds that block life-threatening allergic reactions to insect bites and stings, and food allergies. We emphasize safety in the implementation of research in our practice. Participation in clinical trials often affords patients greater insights into their disorders, as teaching is an integral part of the research that we perform. For more information about current and future studies, please call (714) 633-6363 and ask for Patti Faiman.

We have an active research program as well as representation at the pediatric study section of the National Institute of Health (NIH).  Ongoing projects include evaluating new treatments for respiratory syncytial virus (RSV) in children with cardiac disease and newer noninvasive methodologies in monitoring children after cardiac surgery.  The Division has assisted in the development of new catheters to evaluate coronary problems in children. We recently participated in a national study to evaluate newer inotropic agents following heart surgery as well as management strategies for hypoplastic left heart syndrome.  Future proposed projects involve an important collaboration between the PSF Cardiology Division and the University of California, Irvine. 

Our Critical Care and Neonatology Teams are involved in a variety of clinical research projects that we would like to make you aware of. We are participating in a multi-center study (consisting of 100 children’s hospitals) evaluating the benefits of Activated Protein C (APC) for systemic sepsis in the pediatric patient. Additionally, we are preparing to participate in a study utilizing surfactant in children with acute respiratory distress syndrome (ARDS). We have been selected as one of six sites nationwide to study the use of nitric oxide in pediatric patients with ARDS. We recently completed a project evaluating Milirone in pediatric patients with low cardiac output syndrome following cardiac surgery. Our Peds ICU Team has implemented a database called PICUe’s, which will be valuable in comparing outcomes data with pediatric units nationwide. Our Neonatal Team is actively involved in the Vermont Oxford Studies, comparing outcomes and developing plans for improving outcomes at participating tertiary neonatal sites. Also, we were recently acknowledged in an article published in the New England Journal of Medicine for our participation in a study of high frequency ventilation versus conventional mechanical ventilation in very low birth-weight babies. For more information, please contact our Administrative Office at (714) 532-8620.

Our research efforts are focused on three major areas: Type I Diabetes, Type II Diabetes and Growth Hormone administration. Clinical trials include the NIH sponsored Diabetes Prevention Trial Type I, and as part of this national consortium of pediatric endocrinologists and scientists, we are studying prevention of Type I Diabetes in relatives and preserving the function of the insulin producing pancreatic islet cells in children with new onset diabetes. We are also testing new analogs of insulin for use in pediatric populations and beta testing new insulin pump delivery systems and technologies. With the current epidemic of Type II diabetes in children and in childhood obesity, we are conducting trials to measure safety and efficacy of FDA approved oral medications for children. Our practice participates in the National Growth Hormone Registry that follows some 45,000 children treated with growth hormone for safety and efficacy. In addition, we are involved in growth hormone studies for alternate methods of dosing based on IGF-1 levels rather than the traditional dose based on weight. For more information about current and future studies, contact our Research Coordinator, Heather Speer, MPH, CCRC at (714) 532-8613.

Our GI Division is interested in clinical studies for treatment of GERD, IBD and pseudo-obstruction. We have recently been involved in studies related to irritable bowel syndrome and refractory gastro esophageal reflux disease in children. For information about our research interests and projects, please call our Administrative Office at (714) 289-4099.

We focus our research on the primary areas of inherited thrombosis, factor deficiencies, bleeding and clotting deficiencies and autoimmune diseases. We participate in the Immune and Inflammatory Research Group and serve as the principle director for Region 1 (consisting of 4 states) in the Hemophilia Cohort Study funded by the NCHB and the CDC. Current areas of research interest include focus on platelet dysfunction and production in immune thrombocytopenia and pathogenesis of autoimmune disease. We are funded to study the role of endothelial cells in neonatal coagulation and in clotting stoke disorders. Hematology is also part of the Molecular Medicine Core, which examines the genetic basis of childhood disease. For more information regarding our research and research interests, please call our office at (714) 532-8744.

We serve as principal investigators for clinical trials in Phases I, II, III and IV, with primary focus on trials in Phases III and IV, developing new medications, as well as new uses for existing medications. The clinical trials that we conduct mainly involve new antimicrobials, antifungals and vaccines. Our basic science research is focused in the area of infection/inflammation with the goal of gaining a better understanding of the functions of the body while under attack of infection and in the body’s resolution process. We are looking at responses to infection in multiple infectious syndromes, including UTIs, otitis media and infections in the neonate and premature infant. We hope to better manipulate the immune system to enhance recovery and decrease long-term sequalae mediated by inflammation. We are finalizing our grant with the NIH to become one of only six investigator sites nationwide to test two new anthrax vaccines. For more information, please contact Ofelia Vargas, CCRC at (714) 532-8735.

PSF Nephrology physicians serve as principal investigators for several clinical research studies, providing patients with access to the newest treatment options available. Recent studies have included clinical trials to assess the effectiveness of a new anti-hypertensive medication, an active form of Vitamin D for dialysis patients, and a new long-acting erythropoetin drug for anemia in patients with renal failure. For more information, please contact our Administrative Office at (714) 532-8432.

Our Neurology Division is primarily interested in research for treatment of patients with moderate to severe developmental disabilities. We were also recently awarded two studies in experimental drugs utilized for pediatric patients with epilepsy. The Neurology Division continues to seek out research opportunities that will have the highest benefits for our patients, while focusing on the safety of the studies.       

In addition to being an active member of COG, the Children’s Oncology Group, which develops and maintains nationally recognized state-of-the-art research studies for the array of pediatric oncology diseases, we are also active participants in sponsored pharmaceutical trials. Our current efforts include prevention of tumor lysis syndrome, chronic pain control, central venous catheter occlusion clearance, prevention and treatment of invasive fungal infection, Graft-versus-Host Disease treatment post bone marrow transplantation, and supportive care of myelosupression using long acting hematopoietic growth factors. On the horizon, we are beginning new treatment studies for refractory and/or relapsed leukemia’s and solid tumors, long-acting anti-emetic supportive care, and additional prophylactic anti-fungal care. In our continuing efforts to provide state-of-the-art treatment and supportive care options in the fight against childhood cancers, we also work with the Pediatric Cancer Research Foundation Consortium. For more information about current and future studies, contact Laura Gates, RN at (714) 516-4203.

We continue our research efforts in the area of cord blood research, working to make transplants more effective and more available to patients suffering from a variety of cancers and other conditions, including auto-immune disorders. The CHOC Cord Blood Bank is one of only ten NMDP Cord Blood Banks in the country. Through the NMDP Registry, our bank provides cord blood units to transplant patients worldwide. For more information, please contact Vicki Slone in the Cord Blood Program at CHOC at (714) 289-4154.

Our Pulmonary Team has been actively involved in clinical trials of new therapies for cystic fibrosis, including Inhaled Tobramycin (TOBI), recombinant human DNase (Pulmozyme) and the Epidemiology Study of Cystic Fibrosis. We are also involved in Stage III trials and subsequent studies of Palivizumab (Synagis), a passive vaccine against Respiratory Syncitial Virus for premature infants and those with chronic lung disease. We have presented our work at national and international meetings. We are also involved with the University of California, Irvine on research into the causes and results of treatment of asthma in Orange County. We continue to accept new clinical trials, working as principal investigators to bring new treatment options to children that we care for. For more information, please contact Mary Lee Montgomery, CPNP at (714) 532-8620.

The Rheumatology Division is involved in both basic and clinical research. As part of the Research Institute at CHOC, the Division is involved in the understanding of chronic inflammation in juvenile rheumatoid arthritis (JRA) and DNA repair in systemic lupus erythematosus (SLE). We have cloned a gene expressed in the synovial tissue from inflamed joints from patients with JRA and are exploring its role in the pathogenesis of inflammation. This work is ongoing and has resulted in two abstracts at the American College of Rheumatology meetings and two papers in peer-reviewed journals. Our laboratory is also studying DNA repair in SLE and scleroderma. This is a fascinating area and may lead to a better understanding of disease pathogenesis. Our preliminary work has been presented in one abstract and one paper. We have also been involved in clinical trials for new medications in the treatment of JRA and SLE in children. We have participated in five clinical trials and collected data for future drug marketing. Some of these medications are revolutionizing the care of children with JRA. For more information, please contact our Administrative Office at (714) 532-8617.