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Clinical Trials and Research


Children’s Hospital participates in a number of clinical trials and research opportunities that benefit both the hospital and our patients.

All research is overseen by the Institutional Review Board.  The IRB reviews all research to make sure it is scientifically valid, conducted in such a way as to respect the rights and welfare of our patients, and maintains compliance with all applicable federal and institutional regulations and policies.  Composed of doctors, nurses, community members and hospital staff, the IRB brings together a wide variety of experience.  The IRB also serves to educate hospital staff on the different research processes at the hospital.

Children’s Hospital engages in a number of different types of research.  They include:

  • Clinical Trials – Sponsored either by a private corporation or the National Institutes of Health, these trials provide practical investigation into a drug or medical device, to be used for future marketing applications.
  • Registries – Children’s participates in a number of nationwide registries that capture data on specific populations for use in research of chronic pediatric conditions.  We contribute data to registries on hematology, cystic fibrosis, and diabetes.
  • Oncology ResearchThe Craycroft Cancer Center at Children’s Hospital is part of the Children’s Oncology Group, participating in more than 100 ongoing clinical trials.
  • Investigator Sponsored Research – The largest area of research at Children’s, these projects involve retrospective chart review.  Researchers look at data that has been collected to find trends in patient treatment and outcome, as well as answer questions that arise during research.

Current Clinical Trials

Cardiology

  • Closure of Atrial Septal Defects w/ the Amplatzer Septal Occluder Post-Market Study (ASD PMS II)
    Physician investigator: Carl Owada, MD
  • Use of the Contegra Pulmonary Valve Conduit in Appropriate Patients at Children's Hospital Central California
    Physician investigator:  Edwin Petrossian, MD
  • Protocol for Use of 15mm St. Jude Medical Mechanical Aorta or Mitral Prosthetic Heart Valve
    Physician investigator: Edwin Petrossian, MD
  • Closure of Muscular Ventricular Septal Defects with the AMPLATZER (Muscular VSD Occluder) Post Approval Study (Muscular VPA Study)
    Physician investigator: Carl Owada, MD
  • Outcomes After the Extracardiac Conduit Fontan Operation
    Physician investigator: Edwin Petrossian, MD
  • Outcomes after surgical management of patients with Anomalous Aortic Origin of a Coronary Artery (AAOCA): A collaborative retrospective chart review study between Children’s Hospital Central California (CHCC) and Lucille Packard Children’s Hospital (LPCH)
    Physician investigator: Edwin Petrossian, MD
  • Determining the Natural and “Unnatural” History of Anomalous Aortic Origin of a Coronary Artery with Interarterial or Intraconal or Intramural course (AAOCA): Establishing a Multi-Institutional Registry
    Physician investigator: Edwin Petrossian, MD
  • Coronary Sinus Ostial Atresia: Does this rare anomaly present with other specific congenital cardiac defects?
    Investigator: Kelly Thorson
  • Congenital Heart Disease Cardiac Catheterization Data Consortium
    Physician investigator: Carl Owada, MD
  • Compassionate Use of the CP Covered Stent for treatment of Aortic Arch Abnormalities
    Physician investigator: Carl Owada, MD
  • Medtronic MELODY Transcatheter Pulmonary Heart Valve for use under Humanitarian Device Premarket Approval
    Physician investigator: Carl Owada, MD

Child Advocacy

  • Abusive Head Trauma (AHT) Validation Study
    Physician investigator: Philip Hyden, MD

Employee Health and Wellness

  • What is the effect of not prescribing antimicrobial prophylaxis for hospital employees nosocomially exposed  to pertussis
    Physician investigator: Richard Geller, MD

Endocrinology

  • The ANSWER Program® - American Norditropin® Stuides: Web Enabled Research. An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)
    Physician investigator: Swati Banerjee, MD
  • TrialNet Natural History Study of the Development of Type I Diabetes
    Physician investigator: Swati Banerjee, MD
  • Prevalence of Vitamin D Deficiency in Suspected Child Abuse Patients
    Physician investigator: Renee Kinman, MD
  • Evaluation of Nutrition on the Inpatient Service at Children’s Hospital Central California
    Physician investigator: Swati Banerjee, MD

Hematology

  • Data collection on complications of Hemophilia and serum testing and storage
    Physician investigator: Faisal Razzaqi, MD
  • Epidemiology and evaluation of referral for abnormal coagulation screening tests to pediatric hematology service at Children’s Hospital Central California
    Investigator: Terea Giannetta, NP

Infectious Disease

  • Coccidioidomycosis in Children: A Retrospective Case Series
    Physician investigator: James McCarty, MD

Internal Medicine

  • Penny Ingestion and Zinc Toxicity in the Pediatric Population: An Issue of Common Cents
    Physician investigator: John Kinnison, MD

Neonatal Intensive Care Unit

  • Necrotizing Enterocolitis and Spontaneous Intestinal Perforation in Twins
    Physician investigator: Steven Elliott, MD
  • A randomized clinical trial of therapeutic hypothermia during transport in HIE: Device regulated cooling versus standard practice
    Physician investigator: Kajori Thusu, MD

Nephrology

  • Immunosuppression Minimization to Single Drug Therapy with Sirolimus (Rapamune®) in Pediatric Kidney Transplantation
    Physician investigator: Sahar Barayan, MD 

Neurology

  • Retrospective chart review of stroke in children in a pediatric hospital
    Physician investigator: Steven Ehrreich, MD

Neuropsychology

  • Transition to Adulthood Readiness for Teens and Young Adults with Special Health Care Needs or Chronic Physical Disabilities (YSHCN)
    Physician investigator: Paul Lebby, PhD

Nursing

  • HEADS UP Program Questionnaire
    Investigator: Mary Quintero, RN
  • Pediatric Early Warning System (PEWS) Score Tool Pilot Study
    Investigator: Mary-Ann Robson, RN
  • Development and testing of an instrument to measure Nursing Perception of Components of Professional Practice
    Investigator: Denise Vermeltfoort, RN

Oncology

  • National Wilms Tumor Late Effects Study
    Physician investigator: Vonda Crouse, MD
  • Northern California Childhood Leukemia (UCB) (nee:Molecular Epidemiology of Childhood Leukemia & Environmental Exposures)
    Physician investigator: Vonda Crouse, MD
  • Osteosarcoma biology protocol:  Companion to intergroup therapeutic studies
    Physician investigator: Vonda Crouse, MD
  • A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents with Newly Diagnosed Intermediate Risk Hodgkin Disease
    Physician investigator: Vonda Crouse, MD
  • Phase III Randomized Study of Chimeric Anti-GD1 in High Risk Neuroblastoma Following Myeloablative therapy and Autologous Stem Cell Rescue
    Physician investigator: Vonda Crouse, MD
  • A Children's Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumor
    Physician investigator: Vonda Crouse, MD
  • Classification of Acute Lymphoblastic Leukemia
    Physician investigator: Vonda Crouse, MD
  • High Risk B-Precursor Acute Lymphoblastic Leukemia
    Physician investigator: Vonda Crouse, MD
  • A Phase III Study of Reduced Therapy in the Treatment of Children w/Low & Intermediate Risk Germ Cell Tumors
    Physician investigator: Vonda Crouse, MD
  • A Phase II Study to Assess the Ability of Neoadjuvant Chemotherapy +/- Second Look Surgery to Eliminate All Measurable Disease Prior to Radiotherapy for Non-Germinomatous Germ Cell Tumors (NGGCT)
    Physician investigator: Vonda Crouse, MD
  • 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 Medulloblastoma:  A Phase III Double Randomized Trial
    Physician investigator: Vonda Crouse, MD
  • "Vincristine, Dactinomycin & Lower Doses of Cyclophosphamide with/without Radiation Therapy for Patients w/Newly Diagnosed Low-Risk Embryonal/Botryoid Rhabdomyosarcoma"
    Physician investigator: Vonda Crouse, MD
  • Treatment of Late Isolated Extramedullary Relapse from Acute Lymphoblastic Leukemia (ALL)
    Physician investigator: Vonda Crouse, MD
  • Low Birth Weight and Other Risk Factors for Hepatoblastoma
    Physician investigator: Vonda Crouse, MD
  • 1961, Treatment of Patients with ALL with Unfavorable Features
    Physician investigator: Vonda Crouse, MD
  • Chemotherapy For Progressive Low Grade Astrocytoma in Children less than Ten Years Old
    Physician investigator: Vonda Crouse, MD
  • Primary Surgical Therapy for Biologically Defined Low-Risk Neuroblastomoa
    Physician investigator: Vonda Crouse, MD
  • Phase III Protocol for the Treatment of Children with Hepatoblastoma
    Physician investigator: Vonda Crouse, MD
  • Osteosarcoma biology protocol: Companion to Group-wide Therapeutic Studies
    Physician investigator: Vonda Crouse, MD
  • Escalating Dose Intravenous Methotrexate Without Leucovorin Rescue Versus Oral Methotrexate and Single Versus Double Delayed Intensification Therapy for Children with Standard Risk Acute Lymphoblastic Leukemia
    Physician investigator: Vonda Crouse, MD
  • A Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma
    Physician investigator: Vonda Crouse, MD
  • Trial of Chemotherapy Intensification Through Interval Compression in Ewing Sarcoma and Related Tumors
    Physician investigator: Vonda Crouse, MD
  • A Pilot Study of Re-Induction Chemotherapy with Ifosamide, and Vinorelbine (IV) in Children with Refractory/Relapsed Hodgkin Disease
    Physician investigator: Vonda Crouse, MD
  • Treatment of Very High Risk Acute Lymphoblastic Leukemia in Children and Adolescents
    Physician investigator: Vonda Crouse, MD
  • A Randomized Study of Purged Versus Unpurged Peripheral Blood Stem Cell Transplant Following Dose Intensive Induction Therapy for High Risk Neuroblastoma
    Physician investigator: Vonda Crouse, MD
  • A Phase II Study of Temozolomide in the Treatment of Children with High-Grade Glioma
    Physician investigator: Vonda Crouse, MD
  • A Groupwide Biology and Banking Study for Ewing Sarcoma
    Physician investigator: Vonda Crouse, MD
  • Tumor Registry: Pleuropulmonary Blastoma (PPB)
    Physician investigator: Vonda Crouse, MD
  • A Phase II Trial of Conformal RT for Pediatric Patients with Localized Ependymoma, Chemotherapy prior to 2nd Surgery for Incompletely Resected Ependymoma and Observations for Completely Resected, Differentiated, Supratentorial Ependymoma
    Physician investigator: Vonda Crouse, MD
  • A Children’s Oncology Group Protocol for Collecting and Banking Pediatric Brain Tumor Research Specimens
    Physician investigator: Vonda Crouse, MD
  • A Pilot Study to Determine the Toxicity of the Addition of Rituximab to the Induction and Consolidation Phases and the Addition of Rasburicase to the Reduction Phase in Children with Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated with LMB/FAB Therapy
    Physician investigator: Vonda Crouse, MD
  • A Phase 1 Study of Temsilolimus (CCI-779, IND#61010) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkin Lymphoma
    Physician investigator: Vonda Crouse, MD
  • Late Effects/Survivorship Program
    Physician investigator: John Gates, MD
  • A Phase 2 Multi-Center, Historically-Controlled Study of Dasatinib Added to Standard Chemotherapy in Pediatric Patients with Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
    Physician investigator: Daniel Ozeran, MD
  • Iron Overload in patients with Acute Myeloid Leukemia
    Physician investigator: Daniel Ozeran, MD
  • A prospective multi-institutional study to assess the risk of radiation induced vasculopathy and stroke as well as stroke recurrence in children with cancer who received radiation therapy to the neck and/or brain
    Physician investigator: David Samuel, MD
  • A Phase I Study of AC220 for Children with Relapsed or Refractory ALL or AML (IND111461)
    Physician investigator: Wendy Tcheng, MD
  • A Randomized, Open Label, Multi-center Study to Evaluate the Efficacy and Safety of Decitabine as Epigenetic Priming with Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects
    Physician investigator: Wendy Tcheng, MD
  • A Phase 1 Dose Finding Study of Panobinostat in Children with Refractory Hematoloic Malignancies
    Physician investigator: Wendy Tcheng, MD
  • Treatment of newly Diagnosed Children Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study and a Companion Study
    Physician investigator: Wendy Tcheng, MD

Orthopaedics

  • "The Use of TLSOs in the Treatment of Adolescent Idiopathic Scoliosis: A Prospective, Randomized Controlled Study (BrAIST) - Scoliosis: A Prospective, Randomized Controlled Study (BrAIST)"
    Physician investigator: Joseph Gerardi, DO
  • Verticle Expandable Prosthetic Titanium Rib (VEPTR)
    Physician investigator: Michael Elliott, MD
  • The Chest Wall and Spine Deformity Registry
    Physician investigator: Michael Elliott, MD

Pediatric Intensive Care Unit

  • Preventing Catheter Associated Urinary Tract Infections by Implementing Four Recommended Components of Care
    Investigator: Carole Cooper, RN
  • Targeted Genomic Analysis of Coagulation Pathway in Acute Lung Injury
    Physician investigator: Ana Graciano, MD
  • Development of a Pediatric Sepsis Tool
    Physician investigator: Ana Graciano, MD
  • Rapid Leukodepletion in the Management of Pertussis in Infants <91 days of age
    Physician investigator: Samuel Lehman, MD

Pediatric Surgery

  • Hirschsprung Disease Research Collaboration
    Physician investigator: Doug Tamura, MD

Pharmacy

  • Outcomes of a Clinical Pharmacist Managed Outpatient Pediatric Oral Anticoagulation Service: Comparison w/Management by a Pediatric Cardiology Service
    Investigator: Steve Waite, PharmD
  • Continuous Infusions of Dexmedetomidine in Pediatric ICU Patients
    Investigator: Wenee Lopez, PharmD
  • Impact of CPOE on Patient Care 
    Investigator: Patrick Loo, PharmD
  • Comparison of Poractant alfa and Beractant Treatment in a Premature Neonates with Respiratory Distress Syndrome
    Investigator: Nancy Han, PharmD
  • Evaluation of medication reconciliation upon admission to a children’s hospital
    Investigator: Lynn Warner, PharmD

Plastics

  • Molecular Genetic Analysis of Limb Malformations
    Physician investigator: Peter Witt, MD

Poison Control

  • Death and Life Following Concentrated Bypyridyl Herbicide Exposures: A Case Series
    Physician investigator: Richard Geller, MD
  • Poisoning and Suicide by Cyanide Jewelry Cleaner in the US Hmong Community: A Case Series
    Physician investigator: Richard Geller, MD

Pulmonology

  • Cystic Fibrosis Patient Registry
    Physician investigator: Reddivalam Sudhakar, MD
  • Review of Pediatric Primary Pulmonary Coccidioidomycosis
    Physician investigator: John Moua, MD
  • Collection of CFTR Mutations for Laboratory Quality Assurance
    Physician investigator: Reddivalam Sudhakar, MD
  • Identification and Characterization of CFTR Mutations Among Nonwhite Patients with Cystic Fibrosis to Improve the Clinical Sensitivity of Neonatal Screening and Diagnostic Testing
    Physician investigator: Reddivalam Sudhakar, MD

Urology

  • A Multi-Center, Double-Blind, Placebo-Controlled, Dose Titration Study Evaluating the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Oxybutynin Chloride Topical Gel for the Treatment of Detrusor Overactivity Associated with a Neurological Condition in Pediatric Subjects
    Physician investigator: Devonna Kaji, MD

 

Additional information is available on significant conflicts of interest (COI) regarding PHS funded studies.
 

 

 

 

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