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 Research – The 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.