Clinical research is an important role at the OSF HealthCare Children’s Hospital of Illinois. Hundreds of clinical trials in a wide range of areas are conducted in an effort to discover and deliver more effective treatments. We are able to focus on the discoveries in the lab thanks to our teams of clinicians and researchers. With these great resources, OSF Children’s Hospital is able to offer children the most innovative care available.
Learn more about the research under way in the following areas:
St. Jude Children’s Research Hospital Affiliate
The following studies for care of children with cancer are available through the St. Jude Children’s Research Hospital:
AML08: A Phase III Randomized Trial of Clofarabine Plus Cytarabine Versus Conventional Induction Therapy and A Phase II Study of Natural Killer Cell Transplantation in Patients with Newly Diagnosed Acute Myeloid Leukemia
IPACTR: International Pediatric Adrenocortical Tumor Registry
SJYCO07: Risk-Adapted Therapy for Children Less than 3 Years of Age with Embryonal Brain Tumors, High-Grade Glioma, Choroid Plexus Carcinoma or Ependymoma
Total Therapy Study XVI for Newly Diagnosed Patients with Acute Lymphoblastic Leukemia
HOD08: Reduced Duration Stanford V Chemotherapy With or Without Low-Dose Tailored-Field Radiation Therapy for Favorable Risk Pediatric Hodgkin Lymphoma
SJBC3: Mature B-Cell Lymphoma and Leukemia Study III
ETHEL-A Double-Blind, Randomized, Placebo-controlled Trial of Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line Associated Bloodstream Infection (CLABSI) in Children and Adolescents
ANGIO- Phase I Study of Bevacizumab and Sorafenib Combined with Low Dose Cyclophosphamide in Patients with Refractory Solid Tumors and Leukemia
Children’s Oncology Group
The following studies sponsored through Children’s Oncology Group are available for enrollment:
AREN03B2: Renal Tumors Classification, Biology, and Banking Study
ANHL04B1: Rare and Cutaneous Non-Hodgkin Lymphoma Registry
ARST0531: Randomized Study of Vincristine, Dactinomycin and Cyclophosphomade (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate
*ANBL00P3: A Phase III Randomized Trial of Intravenous Gamma globulin Therapy for Patients with Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated with Chemotherapy and Prednisone (Pedro de Alarcon, MD, Principle Investigator)
ACNS02B3: A Children’s Oncology Group Protocol for Collecting and Banking Pediatric Brain Tumor Research Specimens
ACNS0331: A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children with Newly Diagnosed Standard Risk Meulloblastoma: A Phase III Double Randomized Trial
ALTE03N1: Key Adverse Events after Childhood Cancer
COG ACCRN07: Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)
D9902: A COG Soft Tissue Sarcoma Biology and Tissue Banking Protocol
ABTR04B1: Establishing Continuous Cell Lines and Xenografts from Pediatric Cancers for Biological and Pre-Clinical Therapeutic Studies
ABTR01B1 – A Children’s Oncology Group Protocol for Collecting and Banking Pediatric Rare Pediatric Tumors
COG AREN0532: Treatment for Very Low, Low and Standard Risk Favorable Histology Wilms Tumor
ANBL00B1: Neuroblastoma Biology Studies Protocol
AREN0533: Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumor
AREN0321: Treatment of High Risk Renal Tumors
AEWS07B1: A COG Study for Collecting and Banking Ewing Sarcoma Specimens
ARAR0332: Treatment of Adrenocortical Tumors with Surgery plus Lymph Node Dissection and Multiagent Chemotherapy
AOST06B1: A Children’s Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens
AHOD04B1: Hodgkin Disease (HD) Banking Study
AHEP0731: Treatment of Children with All Stages of Hepatoblastoma
ARST08P1: A Pilot Study to Evaluate Novel Agent Cixutumumab (IMC-A12, Anti-IGF-IR Monoclonal Antibody, IND #100947, NSC #742460) in Combination With Intensive Multi-Agent Interval Compressed Therapy for Patients With High-Risk Rhabdomyosarcoma
ALTE07C1: Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children with Cancer
AREN0534: Treatment for Patients With Multicentric or Bilaterally-Predisposed Unilateral Wilms Tumor
AEWS1031: A Phase III Randomized Trial of Adding Vincristine-topotecan-cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastaic Ewing Sarcoma
ANBL0032: Phase III Randomized Study of Chimeric Antibody 14, 18 (Ch 14, 18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue
ACNS1021: A Phase II Study of Sunitinib (NSC#736511, IND #74019) in Recurrent, Refractory or Progressive High Grade Giloma and Ependymoma tumors in Pediatric and Young Adult Patients
ACNS0822: A Randomized Phase II/III Study of Vorinostat (IND #71976) and Local Irradiation or Temozolomide and Local Irradiation or Bevacizumab and Local Irradiation Followed by Maintenance Bevacizumab (IND #7921) and Temozolomide in Newly Diagnosed High Grade Glioma
The use of the Melody Transcatheter Pulmonary Valve (Melody TPV) for treatment of Right Ventricular Outflow Tract conduit Dysfunction in Accordance with the Melody Humanitarian Device Exemption Indications for Use
Priti M. Patel, MD
Some people with narrowing or absence of the valve between the right pumping chamber of the heart (ventricle) and the artery to the lungs (pulmonary artery) need surgery to treat the problem. Sometimes this includes placement of a tube called a “homograft” or “conduit” between the right ventricle and the pulmonary artery. Deterioration of this tube can result in narrowing and/or leakiness. Until now, the usual treatment has been another operation to replace the tube or a catheterization procedure to enlarge the area with a balloon catheter with or without placement of a wire mesh tube called a “stent”. The catheterization procedures treat narrowing but may increase leakiness. Most people with the tube connections between the right ventricle and pulmonary artery require several operations to replace them throughout their life.
The Medtronic Melody® Transcatheter Pulmonary Valve is a new type of valve that is supported by a stent and was developed to treat narrowing and leakiness in homograft and conduit tubes between the right ventricle and pulmonary artery. It is an approved humanitarian use device (HUD) for treatment of narrowing and/or leakiness in people with a homograft or circumferential conduit between the right ventricle and pulmonary arteries that was at least 16mm in diameter when placed. The approval of an HUD device means that the device is approved as safe and probably beneficial for specific indications because no comparable device is available to treat the disease or condition.
- Child Development
Developmental Pediatric Research
Andrew Morgan, MD
Sponsoring Agency: Kiwanis International
The funds for this grant are contributed for his work on behalf of the Spastic Paralysis Research Foundation.
- Critical Care Medicine
Prototype Development of a Newly Designed Endotracheal Tube
Girish Deshpande, MD
Sponsoring Agency: Children’s Miracle Network, Children’s Hospital of Illinois, University of Illinois College of Medicine Peoria Pediatrics
SecureTube is a new design for an ETT that secures at two locations and enables the tube to move with the patient’s head, thus minimizing Unplanned Extubations (UEs), as well as kinking of the airway. The technological innovations in SecureTube are the second securing location and a rotational component that allows the tube to move from side to side. These novel features will prevent UEs, which results in increased morbidity and healthcare cost.
The objectives are:
- To develop beta prototype for SecureTube to perform the same as or better than existing ETTs with relation to functionality, airflow dynamics, and materials of construction. Additionally, SecureTube should be comparable to current ETT as regards to the intubation procedure.
- Functionality testing of Secure Tube device. SecureTube performs equivalent or better than the current ETTs in the key areas that cause UEs such as excessive secretions, unsupported tubing (with uneven weight distribution, plugged ETT and extubations during procedures. To do this, we will test for three key components: the holding strength of the device when intubated, the weight distribution, and movement of the device compared to existing ETTs.
- Test feasibility of innovative rotational design and develop validations for SecureTube.
Diabetes TN Study Group
Sue Sauder, MD
Sponsoring Agency: TrialNet, Inc.
The Type 1 Diabetes TrialNet is an international diabetes trial network of cooperative clinical research groups to create a stable, high quality infrastructure needed for the conduct of effective and efficient clinical trials in diabetes. TrialNet is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute of Child Health and Human Development (NICHD).
- Healthy Living
Exergaming for Health
Amy Christison, MD
Sponsoring Agency: Children’s Miracle Network
Exergaming for Health is a community based program for overweight children which incorporates a nutritional, behavioral and activity based curriculum with the intention to help children and their families become healthier. Its use of active videogame units as the activity portion of the program makes it a novel and possibly fun and sustainable approach to weight management for children. This research study will assess the effectiveness of this weight intervention program by comparing it to information based dietary education alone by measuring body mass index (BMI) z-scores (relative body mass for age and sex). It will also determine if this program improves activity levels, cardiovascular fitness, physical self-perception, eating habits and reduction in screen time. Participants will be randomly assigned to the exergaming group or the nutrition education group. Measurements of their BMI z-scores, cardiovascular fitness, questionnaires reflecting nutrition, screen time and physical self-perception will be performed at the beginning, 6 months and 12 months of the project. Establishing effective weight management programs for children is a top priority in our nation’s healthcare initiatives. Designing an effective curriculum for weight management intervention services for children in our community, develop an effective weight management curriculum for a multidisciplinary obesity clinic, and fill gaps in the medical literature with stronger scientific evidence establishing the role of exergaming in pediatric obesity management.
The objective of this study is to determine the effectiveness of a community based multifaceted pediatric weight management program incorporating exergaming technology in its curriculum. The aim is to reduce BMI z-scores of the treatment group more than the control group undergoing information based dietary education alone. Secondary aims include improvement of activity levels, cardiovascular fitness, physical self-perception, eating habits, reduction of screen time and sustainability of anthropomorphic changes. Establishing effective management of childhood obesity is a top national healthcare initiative.
Managing Expectations in Pediatric Weight Management: A Pilot Study in Focus on a Fitter Future III Hospitals
Amy Christison, MD
Objectives of this project.
1.To determine whether patient and family congruence between treatment expectations and self-reported progress in these domains is associated with attrition at 3 months. We intend to test this aim with the following hypothesis:
H1: Congruence between treatment expectations and self-reported progress at 3 months will be associated with reduced attrition.
2. To assess feasibility of implementation of a standardized tool to assess patient and family treatment expectations across a variety of pediatric weight management program and clinic formats. We intend to test this aim with the following hypothesis:
H2: A tool to assess learning goals and expectations from patients and families attending a pediatric weight management program can be implemented across multiple institutions with varying size and program formats.
Additionally, we will explore the following potential relationships:
(1) Congruent needs and expectations are less likely for families with a greater number of needs, with needs in multiple domains, and when the parent and patient have differing expectations.
(2) Adolescents and parent/guardians with matched program expectations will demonstrate reduced attrition at 3 months.
(3) Congruent needs and expectations at 3 months will be associated with a significant improvement in BMI z-score.
Characterization of Plasma Factor XIII Antigen and Activity in Very Low Birth Weight Premature Neonates
Michael Tarantino, MD
Sponsoring Agency: Novo Nordisk, Inc.
Hypothesis: Plasma FXIII concentration in the fetus and neonate is dependent upon hepatic maturation and gestational age and low cord blood FXIII activity is associated with an increased risk of intraventricular hemorrhage (IVH).
- To collect data on the incidence of IVH in premature neonates from a dataset of a large Level 3 Neonatal Intensive Care Unit and use neurodevelopmental outcome data to gauge the impact of IVH in premature neonates.
- To measure cord blood antigen concentration and activity of Factor XIII in premature neonates to identify a correlation between low Factor XIII activity and the incidence of IVH.
- To measure other morphometric, co-morbid and hemostatic parameters to identify possible contributors and potential confounding variables to role of low Factor XIII activity in IVH in premature neonates.
Investigate efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopeietin receptor agonist in previously treated patients with chronic ITP
Michael Tarantino, MD
Sponsoring Agency: Glaxo SmithKline
A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).
Hematologic manifestations in pediatrics patients with Mycoplasma infections.
Karen Fernandez, MD
Mycoplasma pneumoniae is one of the common pathogenic bacteria responsible for a wide variety of infectious syndromes. Infection with M. pneumoniae primarily affects the respiratory tract system with symptoms ranging from mild fever, nonproductive cough to severe pneumonia. Extrapulmonary manifestations are also common and include the central nervous system, cardiovascular, gastrointestinal, and hematological systems (1). Hematological complications that are known to occur with M. pneumoniae infection include hemolytic anemia, thrombocytopenia, thrombotic thrombocytopenic purpura (TTP) and hemophagocytosis.
For the past few years, we observed several pediatrics patients who presented with severe clinical manifestations of M. pneumoniae infection had the changes in peripheral blood esosinophilia. The mechanisms of eosinophilia in M. pneumoniae infection are poorly understood. In fact, it is not yet certain whether peripheral blood eosinophilia was caused directly by M. pneumoniae infection. Interestingly, Medina et al recently reported that M. pneumoniae can produces an ADP-ribosylating and vacuolating toxin termed the CARDS toxin which induced an increased expression of the Th-2 cytokines IL-4 and IL-13 and Th-2 chemokines CCL17 and CCL22 resulting in a mixed cellular inflammatory response comprised of a robust eosinophilia in pulmonary tissues (2). However, the role of M. pneumoniae infection and eosinophilia is just emerging and data are very limited.
Thus, the objective of this study is to evaluate prevalence of peripheral blood eosinophilia among patients with M. pneumoniae infection.
Sickle Cell Disease
Medical Services for Newborns and Children with Abnormal Hemoglobins
Kay Saving, MD
Sponsoring Agency: Illinois Department of Public Health
The Illinois Department of Public Health (IDPH), Office of Health Promotion, will provide funding to hematology centers to assure the availability of statewide services to families in Illinois who have a newborn or child with a hemoglobin disorder or trait. Sickle cell centers will provide diagnostic services, treatment and counseling of patients. In addition, education and information about hemoglobin disorders and treatment will be provided to health care providers and the public.
Sickle Cell Disease Treatment Demonstration Project
Kay Saving, MD
In 2004 Congress enacted legislation authorizing a demonstration program for the prevention and treatment of Sickle Cell Disease (SCD). The legislation was enacted to (1) create an optional medical assistance program for individuals with Sickle Cell Diseases for treatment and education, genetic counseling and other services to prevent mortality and decrease morbidity from Sickle Cell Disease; and (2) create a demonstration program, the Sickle Cell Disease Treatment Demonstration Project (SCDTDP), under Health Resources and Services Administration (HRSA).
Under the authorizing legislation, a National Coordinating Center (NCC) was established to collect, coordinate, monitor, and distribute data, best practices and findings regarding the activities of the demonstration program.
Staphylococcus Colonization and Infection in the Neonatal Intensive Care Unit
Barry Gray, MD
Sponsoring Agency: Children’s Hospital of Illinois
The aim of this study is to establish an ongoing comprehensive surveillance program to monitor and study staphylococcal colonization and infection in our Neonatal Intensive Care Unit. The short-term goal is to implement an operational framework to support the initial stages of projects focused on Staphylococcus aureus/MRSA and Staphylococcus epidermidis. The long-term goal is to improve infection control strategies and reduce the burden of preventable disease in the Neonatal Intensive Care Unit.
Association of stress-induced hyperglycemia (SIH) and acute kidney injury (AKI) in critically ill children and adolescents.
Roberto Gordillo, MD
Stress-induced hyperglycemia (SIH) is common in critically ill patients and it has been associated with increased mortality and morbidity in adults and children [1-3]. However, it is still not clear whether SIH correlates with acute kidney injury (AKI) . The incidence of AKI in critically ill patients is difficult to estimate because of a lack of standard definition. Over 30 definitions of AKI have been published .
AKI is associated with significant mortality, as high as 60% . Therefore prevention of AKI is crucial, and includes hemodynamic support, maintenance of euvolemia, and avoidance of nephrotoxic medications. Current research has identified a set of kidney injury biomarkers, i.e. neutrophil gelatinase-associated lipocalcin (NGAL), osteopontin (OPN), kidney injury molecule-1 (KIM-1), that may allow early clinical recognition of patients at risk for AKI .
However, those biomarkers were not evaluated during stress-hyperglycemia states.
Mitochondrial Genome Damage in Neurologic Disease
William D. Parker, MD
The objective of this project is to conduct extremely in depth sequencing studies of mitochondrial DNA recovered from blood platelets from patients with several different sporadic brain diseases. The specific hypothesis is that patients with a given brain disease will have more point mutations in regions of mitochondrial DNA than will be found in healthy controls.
Congenital Spine Stimulator
Julian Lin, MD
Sponsoring Agency: Children’s Miracle Network
Simulation is a useful tool for training residents and in ascertaining competency. One of the most common procedures in pediatric neurosurgery is spinal cord detethering. Prior to “real-time and hands-on” experience in operating on actual patients, simulation will allow trainees to learn anatomy and the steps wise progress in an actual procedure. Obtaining technical proficiency outside of the operating room should ultimately result in better outcomes. Currently, there are no available congenital spine simulators. We propose to design and fabricate a high fidelity congenital spine simulator that will allow trainees to simulate common congenital spine surgeries such as spinal cord detethering. The simulator will be modular and materials used will be as life-like as possible. In addition, the simulator will provide electrophysiological feedback and include components such as simulated nerve roots, spinal cord, CSF etc. The project will be carried out by four senior Bradley mechanical engineering students during the academic year 2011-12. There will be quarterly reports and presentations at a national pediatric neurosurgery conferences as well as preliminary filing of patent are expected.
Family Nutritional Physical Activity Tool
Amy Christison, MD
The primary objective of this investigation is to assess the acceptability and feasibility of the Family Nutritional Physical Activity (FNPA) assessment and coaching tool when applied in the primary care setting in an observational pilot study. The secondary objectives are to evaluate the influence of this intervention on motivation and plans for change of obesigenic behaviors in the study subjects and their families as well as short term body mass index (BMI) change. In addition, the tool's influence on practitioner self-efficacy in the area of obesigenic lifestyle counseling and fidelity of MI techniques will be examined.