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

Viaskin® Peanut skin patch drug trial

  • Principal Investigator: Jay A. Lieberman, MD
  • Trial to assess the safety and efficacy of Viaskin® Peanut in peanut-allergic young children
  • Ages 1 to 3, diagnosed allergy to peanuts, following strict peanut-free diet

Dupilumab drug trial

  • Principal Investigator: Jay A. Lieberman, MD
  • Trial to investigate the efficacy and safety of dupilumab in adolescent patients with eosinophilic esophagitis
  • Age 12 years or older

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

Amplatzer muscular VSD occluder device study

  • Principal Investigator: Benjamin R. Waller, MD
  • Post approval study for the closure of muscular ventricular septal defects (VSDs) with the amplatzer muscular VSD occluder
  • Must meet at least one of the following criteria:
    • Large volume left to right shunt
    • Pulmonary hypertension
    • Clinical symptoms of congestive heart failure
    • Banding of the pulmonary artery and in the opinion of the treating investigator, closure of the VSD is clinically warranted

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

Effects of insulin resistance and FGF21 on cardiac function in pediatric dilated cardiomyopathy

  • Principal Investigator: Daniel Mak, MD
  • Data collection study of patients age 13-18 years with dilated cardiomyopathy or hypertrophic cardiomyopathy

Alogliptin drug trial

  • Principal Investigator: Amit Lahoti, MBBS, MD
  • Evaluate efficacy and safety of alogliptin in children with type 2 diabetes mellitus
  • Ages 10 to 17 years experiencing inadequate diabetes control

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

Sparsentan drug trial

  • Principal Investigator: John Bissler, MD
  • Study of the effects of sparsentan, a dual endothelin reception and angiotensin receptor blocker, on renal outcomes
  • Ages 8 and older with diagnosis of primary focal segmental glomerulosclerosis (FSGS)

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

BRV drug trial

  • Principal Investigator: James Wheless, MD
  • Evaluate the pharmacokinetics, safety and tolerability of intravenous BRV
  • 1 month to 16 years with epilepsy diagnosis being treated with epilepsy medication

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

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: Joan Han, 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: Joan Han, 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: Joan Han, 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

Aerovanc drug trial

  • Principal Investigator: Tricia Dubin, MD
  • Study of aerovanc for the treatment of persistent methicillin-resistant staphylococcus aureus (MRSA)
  • Less than 21 years of age with diagnosis of cystic fibrosis and persistent MRSA lung infection

Contrast enhance voiding urosonograpy (ceVUS) trial

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

Updated July 1, 2020