Pediatrics

Below are current clinical trials.

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1. C. Albicans during Early Life Predisposes Individuals to Atopy

   Rochester, Minn.

   The purpose of this study is to evaluate the contribution of C. albicans to dysbiotic microbial communities of mucosal tissues in pediatric populations. Prospective sampling across multiples tissue sites in a pediatric cohort will be used to assess which tissues are colonized by C. albicans and associated with microbial dysbiosis seen in atopic dermitis.

   We hypothesize presence of C. albicans in the microbial communities in early life is associated with atopy. We will assess the presence of C. albicans in the microbial communities of a population of children at-risk for atopic dermatitis compared to healthy controls who do not have an underlying risk for atopy based off family history. In tandem with the collection of human samples, we will utilize mouse models to validate the influence of C. albicans exposure during early life on the systemic immune populations.

    

2. Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease

   Rochester, Minn.

   Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a significant public health problem (affects 1 in 740 boys between ages 0-14), but uncommon enough to have a sufficient number of patients from a single institution to perform a definitive prospective study comparing the results of current treatments. The present study will establish a database of prospectively identified patients with Legg-Calvé-Perthes (LCP) Disease and collect information regarding their presentation, treatment, and outcomes in the course of receiving currently available treatments. This study seeks to compare the outcomes of current treatments in the management of different age groups (ages 1-6, 6-8, 8-11, >11) of patients with Perthes disease at two- and five-year followup and at skeletal maturity. For each age group, two to three common treatment regimens currently used by practicing pediatric orthopaedic surgeons will be compared. The intervention a patient receives is determined through physician treatment expertise, and is not pre-determined by the study.

3. Clinical and Basic Investigations into Congenital Disorders of Glycosylation

   Jacksonville, Fla., Rochester, Minn.

   The purpose of this study is to establish the prevalence and severity of specific morbid indicators of disease severity such as specific organ system involvement, degree of cognitive disability, and case-fatality associated with various congenital disorders of glycosylation (CDG), and establish a dynamic platform to effectively disperse clinically relevant findings to families, non-expert clinicians and researchers, as well as provide a verified method to link these individuals to experts in CDG.

    

4. A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma

   Rochester, Minn.

   The pupose of this study is to evaluate whether or not selumetinib works just as well as the standard treatment with carboplatine/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by blocking some enzymes that low grade glioma tumor cells need for their growth. This results in killing tumor cells. Drugs used as chemotherapy, such as carboplatin and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether selumetinib works better in treating patients with NF1-associated low-grade glioma compared to standard therapy with carboplatin and vincristine.

5. Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients with Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorder

   Rochester, Minn.

   The purpose of this Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.

6. A Study to Evaluate a Primary Care-Based Intervention for Adolescent Restrictive Eating Disorders

   Rochester, Minn.

   The purpose of this study is to assess the feasibility, acceptability, usability, and preliminary outcomes of a treatment protocol (FBT-PC) for PCP management of adolescent restrictive eating disorders.

7. Prospective Identification of Long QT Syndrome in Fetal Life

   Rochester, Minn.

   The postnatal diagnosis of Long QT Syndrome (LQTS) is suggested by a prolonged QT interval on 12 lead electrocardiogram (ECG),a positive family history and/or characteristic arrhythmias and confirmed by genetic testing.  LQTS testing cannot be performed successfully before birth as   fetal ECG is not possible and direct measure of the fetal QT interval by magnetocardiography is limited. Genetic testing can be performed in utero, but there is risk to the pregnancy and the fetus. Although some fetuses present with arrhythmias easily recognized as LQTS (torsade des pointes (TdP) and/or 2° atrioventricular (AV) block, this is uncommon, occurring in <25% of fetal LQTS cases. Rather, the most common presentation of fetal LQTS is sinus bradycardia, a subtle rhythm disturbance that often is unappreciated to be abnormal. Consequently, the majority of LQTS cases are unsuspected and undiagnosed during fetal life, with dire consequences. For example, maternal medications commonly used during pregnancy can prolong the fetal QT interval and may provoke lethal fetal ventricular arrhythmias. But the most significant consequence is the missed opportunity for primary prevention of life threatening ventricular arrhythmias after birth because the infant is not suspected to have LQTS before birth. The over-arching goal of the study is to overcome the barriers to prenatal detection of LQTS. The investigators plan to do so by developing an algorithm using fetal heart rate (FHR) which will discriminate fetuses with or without LQTS. Immediate Goal: The investigators propose a multicenter pre-birth observational cohort study to develop a Fetal Heart Rate (FHR)/Gestational Age (GA) algorithm from a cohort of fetuses recruited from 13 national and international centers where one parent is known by prior genetic testing to have a mutation in one of the common LQTS genes: potassium voltage-gated channel subfamily Q member 1 (KCNQ1), potassium voltage-gated channel subfamily H member 2 (KCNH2), or sodium voltage-gated channel alpha subunit 5 (SCN5A). The investigators have chosen this population because 1) These mutations are the most common genetic causes of LQTS, and 2) Offspring will have high risk of LQTS as inheritance of these LQTS gene mutations is autosomal dominant. Thus, progeny of parents with a known mutation are at high (50%) risk of having the same parental LQTS mutation. The algorithm will be developed using FHR measured serially throughout pregnancy. All offspring will undergo postnatal genetic testing for the parental mutation as the gold standard for diagnosing the presence or absence of LQTS.

8. A Study of Noninvasive Hemoglobin Monitoring in Pediatric Patients Undergoing Orthopedic Surgery

   Rochester, Minn.

   The purposes of this study are to validate noninvasive hemoglobin monitoring in postoperative orthopedic pediatric patients, to evaluate patient, parent, and provider preference of noninvasive hemoglobin monitoring compared to invasive blood draw, and to evaluate cost effectiveness of noninvasive monitoring in comparison to invasive blood draws.

9. Bioengineered Cardiac Tissue for Hypoplastic Left Heart Syndrome Analysis

   Rochester, Minn.

   The purpose of this study is to produce and characterize patient-specific cardiac tissue for Hypoplastic Left Heart Syndrome (HLHS) using reprogrammed cell technology.

10. A Study to Evaluate the Performance of an Advanced Algorithm with CGM in Adults, Adolescents, and Pediatrics

    Rochester, Minn.

    The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).