Clinical Trials

At the Children’s Foundation Research Institute, we investigate the latest medications and devices by participating in clinical trials exploring the efficacy of these new treatments. Below is a list of our trials that are currently enrolling patients.

If you have questions regarding one of the clinical trials below, contact us.

byrd trial body photo

Dupilumab drug trial

  • Principal Investigator: Jay A. Lieberman, MD
  • Trial to investigate the efficacy and safety of dupilumab in pediatric patients with active eosinophilic esophagitis
  • Ages 1 to 12 years

Aminophylline drug trial

  • Principal Investigator: Umar Boston, MD
  • Effect of aminophylline on preventing acute kidney injury in neonates and infants with congenital heart disease undergoing open heart surgery
  • Neonates less than 1 year needing cardiac surgery for congenital heart defect OR less than 18 years needing heart transplant

Exdoxaban drug trial

  • Principal Investigator: Mario Briceno-Medina, MD
  • Evaluate the pharmacokinetics and dynamics of edoxaban and compare efficacy and safety of edoxaban with SOC anticoagulant therapy
  • 0 to 18 years of age with documented venous thromboembolism needing anticoagulant therapy

    Be Empowered Grow Intentionally Now

    • Principal Investigator: Kathryn Sumpter, MD
    • Device to track continuous glucose monitoring
    • Ages 8 to 17, patient of Le Bonheur’s Endocrine Clinic, poor management of diabetes, enrolled in TennCare health insurance

    TrialNET: Natural History Study of the Development of Type 1 Diabetes

    • Principal Investigator: Alicia Diaz-Thomas, MD
    • The overall objective of this study is to perform baseline and repeat assessments over time of the metabolic an dimmunologic status of individuals at risk for Type 1 diabetes (T1D) to:
      • Characterize their risk for developing T1D and identify subjects eligible for prevention trials
      • Describe the pathogenic evolution of T1D
      • Increase the understanding of the pathogenic factors involved in the development of T1D

    Teplizumab monoclonal antibody trial

    • Principal Investigator: Ramin Alemzadeh, MD
    • Evaluate efficacy and safety of teplizuman (PRV-031), a humanized, FcR non-binding, anti-CD3 monoclonal antibody
    • Ages 18 and younger with newly diagnosed Type 1 diabetes

      Dapagliflozin and saxagliptin drug trial

      • Principal Investigator: Amit Lahoti, MD, MSc
      • Evaluate the safety and efficacy of dapagliflozin 5 and 10 mg and saxagliptin 2.5 and 5 mg
      • Ages 10 and 18 years with Type 2 diabetes mellitus

      Regeneron COVID-19 study

      • Principal Investigator: Sandra Arnold, MD
      • Determine the efficacy of REGEN-COV antibody cocktail treatment 
      • Ages 0 to 17 years with at least one risk factor, who have tested positive within the last three days for COVID-19 and are not currently or previously hospitalized due to COVID-19
      • Study coordinator: Lauren Davis (901) 287-4594 or lauren.davis2@lebonheur.org

      RSV study

      • Principal Investigator: Timothy Dean Minniear, MD, MSc
      • Determine the morbidity and mortality associated with respiratory syncitial virus (RSV) infection in children
      • Ages 3 to 17 years with RSV infection within 1 year of transplantation procedure

      ContraFect staph study

      • Principal Investigator: Sandra Arnold, MD
      • Determine the efficacy and safety of a single dose of exebacase in patients receiving standard of care antibiotics for the treatment of staphylococcus aureus bloodstream infections (bacteremia), including right-sided infective endocarditis

      RSV Janssen DAISY study

      • Principal Investigator: Sandra Arnold, MD
      • Evaluate the efficacy and safety of rilematovir 
      • Infants and children ages 28 days to 5 years and neonates under 28 days hospitalized with acute respiratory tract infection due to respiratory syncytial virus (RSV)

      RSV Enanta study

      • Principal Investigator: Sandra Arnold, MD
      • Evaluate EDP-938 regiments 
      • Ages 28 days to 24 months infected with respiratory syncytial virus (RSV)

        PIVOTAL Pilot Study

        • Principal Investigator: Mark Weems, MD
        • Device trial for ages 14-28 days with significant patent ductus arteriosus (hsPDA)

        Amplitude integrate electroencephalogram (aEEG) in newborns exposed to prenatal illicit substances

        • Principal Investigator: Divya Rana, MD
        • All infants and their mothers, admitted to The Newborn Center’s well baby nursery (WBN) or neonatal intensive care unit (NICU) with history of maternal illicit or prescription substance use during pregnancy

        Brivaracetam drug trial

        • Principal Investigator: James Wheless, MD
        • Long-term study to evaluate safety and efficacy of brivaracetam used as adjunctive treatment in pediatric patients with epilepsy
        • Must have completed prior participation in other related study

          Aucta TSC face cream drug trial

          • Principal Investigator: James Wheless, MD
          • Ages 2 to 18 years with diagnosis of tuberous sclerosis complex (TSC) and visible facial angiofibromas

          Human Tissue Study

          • Principal Investigator: James Wheless, MD
          • Use of extra tissue samples obtained during brain surgery to look for any changes in proteins and genes in the tissue
          • Ages 4 to 13 years with epilepsy and receiving epilepsy surgery

          Raise

          • Principal Investigator: James Wheless, MD
          • Evaluate the efficacy and safety of intravenous ganaxolone ins tatus epilepticus
          • 12 years of age with status epilepticus (SE)

          Novel side positioner vest device trial

          • Principal Investigator: Stephanie Einhaus, MD
          • Efficacy and safety of a novel side vest positioner in treating and preventing human infant occipital plagiocephaly
          • Healthy infants ages 1 to 10 months

          Low-frequency TMS treatment for refractory complex partial epilepsy

          • Principal Investigator: Shalini Narayana, PhD
          • 5 years or older and diagnosed with refractory epilepsy with partial-onset seizures

          Functional brain mapping using transcranial magnetic stimulation

          • Principal Investigator: Shalini Narayana, PhD
          • Healthy volunteers and patients with neurological and psychiatric disorders ages 3 to 17 years

          Setmelanotide (RM-493) drug trial

          • Principal Investigator: Ahlee Kim, MD
          • Treatment of obesity and hyperphagia in patients diagnosed with Bardet Biedl Syndrome (BBS) or Alstrom Syndrome (AS) in ages 6 or older

          Setmelanotide (RM-493) extension drug trial

          • Principal Investigator: Ahlee Kim, MD
          • Long term extension trial of setmelanotide for patients who have completed a trial of setmelanotide for the treatment of obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway
          • Must have completed participation in related setmelanotide study

          Setmelanotide (RM-493) drug trial for rare genetic disorders of obesity

          • Principal Investigator: Ahlee Kim, MD
          • Ages 6 and above with specific genotypes for rare genetic disorders of obesity

          Post-operative pain management drug trial

          • Principal Investigator: Lindsey Locke, MSN, CPNP-PC
          • Ages 4 to 13 years with diagnosis of supracondylar humerus fracture needing percutaneous pinning

          Scoliosis analog model for evaluation of bracing technology

          • Principal Investigator: Denis Diangelo, PhD
          • Ages 5 to 17 years diagnosed with idiopathic scoliosis

          Intra-operative ketorolac drug trial

          • Principal Investigator: Anthony Sheyn, MD
          • Intra-operative ketorolac to decrease pain and narcotic use in immediate post-operative period following tonsillectomy or adeno-tonsillectomy
          • Ages 2 to 18

          Fibrin Sealant Grifols drug trial

          • Principal Investigator: Max Langham, MD
          • Evaluate the safety and efficacy of Fibrin Sealant Grifols as an adjunct to hemostasis during pediatric surgeries
          • Elective open (non-laparoscopic) surgery for pelvic, abdominal or thoracic where a hemostatic agent is needed, under 18 years

          Contrast enhance voiding urosonograpy (ceVUS) trial

          • ceVUS for diagnosis of vesicoureteral reflux in children
          • Ages 0 to 17 years


          Updated March 29, 2021