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.

Le Bonheur patient Charlie Byrd being cared for in clinical trials by Dr. Tracee Ridley Pryor

VITESSE Peanut Allergy Patch

  • What kind of research is this? A study of a medicine called DBV712 worn as a patch for children with peanut allergies.
  • Who is this for? Children 4 to 7 years old who have a diagnosed peanut allergy and are now on a strict peanut-free diet.
  • Who is the doctor in charge of this study? Jay Lieberman, MD

Status: We are currently looking for patients for this study 

    If you are interested in enrolling or would like more information, please contact the study coordinator: Alyssa Maria Kintanar, 901.2875044, alyssamarie.kintanar@lebonheur.org.

    ClinicalTrials.gov information:

     

    Baby Talk in TSC

    • What kind of research is this? A study to see if babbling in babies with Tuberous Sclerosis Complex (TSC) may be related to language development problems or autism.
    • Who is this for? Babies who are up to 36 months old with a diagnosis of Tuberous Sclerosis Complex.
    • Who is the doctor in charge of this study? Tanjala Gipson, MD

    Status: We are currently looking for patients for this study 

      If you are interested in enrolling or would like more information, please contact the study coordinator: kathryn Ryan, 901.287.5425, kathryn.ryan@lebonheur.org.

      Be Empowered Grow Intentionally Now (BEGIN) 

      • What kind of research is this? A study of managing diabetes with a device for continuous glucose monitoring instead of periodic monitoring with testing strips 
      • Who is this for? Current patients with diabetes from our Endocrine Clinic with TennCare insurance who are between 8 to 17 years old 
      • Who is the doctor in charge of this study? Kathryn Sumpter, MD  

      Status: We are currently looking for patients for this study 

      If you are interested in enrolling or would like more information, please contact the study coordinator: Susan Steppe, 901.287.4704, Susan.Steppe@lebonheur.org 

      TrialNET: Natural History Study of the Development of Type 1 Diabetes (T1D) 

      • What kind of research is this? A study of the risk for developing type 1 diabetes in children who have relatives with type 1 diabetes 
      • Who is this for? Children and adolescents older than 2-and-a-half years of age with a parent, sibling, niece, nephew, aunt, uncle, cousin, or half-sibling who has type 1 diabetes 
      • Who is the doctor in charge of this study? Kathryn Sumpter, MD

      Status: We are currently looking for patients for this study 

      If you are interested in enrolling or would like more information, please contact the study coordinator: Katie Ryan, 901.287.5425, kathryn.ryan@lebonheur.org 

      ClinicalTrials.gov information:  

      • No current trials available. Please check back later.

      Aminophylline drug trial

      • What kind of research is this? A study of Aminophylline to protect kidney function for children undergoing heart surgery 
      • Who is this for? Newborns who are less than 28 days old and infants less than 1 year old who were born with heart defects and need open heart surgery; and patients less than 18 years old who need a heart transplant 
      • Who is the doctor in charge of this study? Umar Boston, MD 

      Status: We are currently looking for patients for this study 

        If you are interested in enrolling or would like more information, please contact the study coordinator: Kathryn Carpenter, 901.287.5035, kathryn.carpenter@lebonheur.org.

        ClinicalTrials.gov information:  

        COMPASS Trial: a Direct Aspiration First Pass Technique

        • What kind of research is this? To investigate if a stent or shunt is better for keeping the duct (passageway) between the heart and lungs open.
        • Who is this for? Babies up to 30 days old born with congenital heart disease that affects the blood flow between the heart and lungs. (The medical term is "ductal-dependent pulmonary blood flow.")
        • Who is the doctor in charge of this study? Shyam Sathanandam, MD  

        Status: We are currently looking for patients for this study 

          If you are interested in enrolling or would like more information, please contact the study coordinator: Kathryn Carpenter, 901.287.5035, kathryn.carpenter@lebonheur.org 

          ClinicalTrials.gov information:  

          • Official Name: Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial) (COMPASS)
          • Identifier: NCT05268094 (https://beta.clinicaltrials.gov/study/NCT05268094)

          COMPASSION Heart Valve Trial

          • What kind of research is this? A study of new transcatheter heart valve systems for children and adults
          • Who is this for? Children and adults who weigh more than 44 pounds with a malfunctioning right ventricular outflow tract (RVOT) or previously implanted pulmonary valve. 
          • Who is the doctor in charge of this study? Shyam Sathanandam, MD  

          Status: We are currently looking for patients for this study 

            If you are interested in enrolling or would like more information, please contact the study coordinator: Kathryn Carpenter, 901.287.5035, kathryn.carpenter@lebonheur.org 

            ClinicalTrials.gov information:  

            Renata Minima Stent Trial 

            • What kind of research is this? A study of a new stent that keeps the blood vessel open treatment of Coarctation of the Aorta or Pulmonary Artery Stenosis 
            • Who is this for? Infants and children between 0 and 7 years old requiring treatment for Coarctation of the Aorta or Pulmonary Artery Stenosis 
            • Who is the doctor in charge of this study? Shyam Sathanandam, MD  

            Status: Active not recruiting

              If you are interested in enrolling or would like more information, please contact the study coordinator: Kathryn Carpenter, 901.287.5035, kathryn.carpenter@lebonheur.org 

              ClinicalTrials.gov information:  

              Official Name: Growth Trial: Study of the Renata Minima Stent 

              Identifier: NCT05086016 (https://beta.clinicaltrials.gov/study/NCT05086016 

              VALOR Clinical Trial of Vericiguat 

              • What kind of research is this? A study of the medicine Vericiguat for heart failure due to systemic left ventricular systolic dysfunction (VALOR) 
              • Who is this for? Infants, children, adolescents, and teenagers between 28 days old to 18 years old 
              • Who is the doctor in charge of this study? Jeffrey A. Towbin, MD, MS 

              Status: We are currently looking for patients for this study 

                If you are interested in enrolling or would like more information, please contact the study coordinator: Kathryn Carpenter, 901.287.5035, kathryn.carpenter@lebonheur.org 

                  CIViC-19 (COVID-19 study) 

                  • What kind of research is this? A study of how the immune system responds to the virus that causes COVID-19 and how the virus might change during the course of an infection 
                  • Who is this for? Patients from birth to 90 years old who are Positive for COVID-19, the household contacts of enrolled subjects, and control group patients who are negative COVID-19  
                  • Who is the doctor in charge of this study? Heather Smallwood, PhD  

                  Status: We are currently looking for patients for this study 

                  If you are interested in enrolling or would like more information, please contact the study coordinator: Ashley Blair, 901.634.6342, CIVIC19study@live.utk.edu 

                  Aztreonam and Avibactam (ATM-AVI) for Infections

                  • What kind of research is this? This study looks at how of Aztreonam-Avibactam (ATM-AVI) works for pediatric patients with infection.
                  • Who is this for? Pediatric patients aged 9 months to 18 years of age who are hospitalized with a suspected or confirmed complicated gram-negative infection(s) and receiving intravenous antibiotics; areas of infection include the abdomen, urinary tract, blood stream, and lungs.
                  • Who is the doctor in charge of this study? Maria Carrillo-Marquez, MD

                  If you are interested in enrolling or would like more information, please contact the study coordinator: Katie Ryan, 901-287-5425, kathryn.ryan@lebonheur.org.

                  ClinicalTrials.gov information:

                  RSV Enanta Study 

                  • What kind of research is this? A study of how well a medicine called EDP-938 can treat respiratory syncytial virus (RSV) 
                  • Who is this for? Newborns and infants 28 days old to 24 months old who have a respiratory syncytial virus (RSV) infection 
                  • Who is the doctor in charge of this study? Sandra Arnold, MD  

                  Status: We are currently looking for patients for this study 

                    If you are interested in enrolling or would like more information, please contact the study coordinator: Nick Leal, 901.287.5886, nicolas.leal@lebonheur.org 

                    ClinicalTrials.gov information:  

                    Congenital CMV Biomarker Study

                    • What kind of research is this? This study will find out test results can be used to determine how hearing will be impacted in babies with a congenital cytomegalovirus (CMV) infection
                    • Who is this for? Infants 0 to 55 days old
                    • Who is the doctor in charge of this study? Maria Carrillo-Marquez, MD

                    If you are interested in enrolling or would like more information, please contact the study coordinator: Kara Lessel, 901.287.4594, kara.lessel@mlh.org.

                    Moderna Baby COVE Study

                    • What kind of research is this? A study of a new vaccine to prevent COVID-19 infection in babies.
                    • Who is this for? Babies who are between 12 weeks old to 6 months old.
                    • Who is the doctor in charge of this study? Maria Carrillo-Marquez, MD

                    Status: Active, enrollment paused

                    If you are interested in enrolling or would like more information, please contact the study coordinator: Katie Newsom, 901.287.5179, Katherine.Newsom@lebonheur.org.

                      Amplitude Integrate Electroencephalogram (aEEG) in Newborns Exposed to Prenatal Illicit Substances  

                      • What kind of research is this? A study of how well a test called an amplitude integrate electroencephalogram (aEEG) works in newborns who were exposed to illicit substances before birth 
                      • Who is this for? All infants and their mothers admitted to The Newborn Center’s well baby nursery (WBN) or neonatal intensive care unit (NICU); mothers have a history of prescription substance use during pregnancy 
                      • Who is the doctor in charge of this study? Divya Rana, MD  

                      Status: We are currently looking for patients for this study 

                      If you are interested in enrolling or would like more information, please contact the study coordinator: Gail Camp, 901.448.1823, lcamp@uthsc.edu 

                      PIVOTAL Pilot Study 

                      • What kind of research is this? A study of how well a device works for treating patients with ductus arteriosus (hsPDA) 
                      • Who is this for? Newborns aged 14 to 28 days of age with patent ductus arteriosus (hsPDA) 
                      • Who is the doctor in charge of this study? Mark Weems, MD  

                      Status: We are currently looking for patients for this study 

                      If you are interested in enrolling or would like more information, please contact the study coordinator: Gail Camp, 901.448.1823, lcamp@uthsc.edu 

                      Biohaven Pharmaceuticals Study of Rimegepant for Migraines

                      • What kind of research is this? A study to use a new medicine called Rimegepant to treat children and adolescents who suffer from migraine headaches
                      • Who is this for? Children between 6 to 18 years old who have a history of migraine headaches. The migraines can either be with or without aura
                      • Who is the doctor in charge of this study? Ankita Ghosh, MD

                      Status: Active not recruiting

                      If you are interested in enrolling or would like more information, please contact the study coordinator: Nick Leal, 901.287.5886, nicolas.leal@lebonheur.org.

                      EpiCom Study

                      • What kind of research is this? This study will look at using a medication called Epidiolex as an add-on medicine for children and adults with tuberous sclerosis complex (TSC) and seizures.
                      • Who is this for? Infants and children from 1 year old to adults 65 years old
                      • Who is the doctor in charge of this study? Sarah Weatherspoon, MD

                      Status: We are currently looking for patients for this study.

                      If you are interested in enrolling or would like more information, please contact the study coordinator: Adrienne West, 901.287.4473, adrienne.west@lebonheur.org.

                      ClinicalTrials.gov information:  

                      • Official Name: A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex (EpiCom)
                      • Identifier: NCT05864846 (https://clinicaltrials.gov/study/NCT05864846)

                        Functional brain mapping using transcranial magnetic stimulation  

                        • What kind of research is this? A study of a test called functional brain mapping that uses a a procedure called transcranial magnetic stimulation (TMS) to look for brain changed in people with neurological or psychological disorders 
                        • Who is this for? Children and adolescents 3 and 17 years old with a neurological or psychological disorder and healthy volunteers without neurological or psychological disorders and  
                        • Who is the doctor in charge of this study? Shalini Narayana, PhD  

                        Status: We are currently looking for patients for this study 

                        If you are interested in enrolling or would like more information, please contact Dr. Shalini Narayana, 901.287.4616, snaraya2@uthsc.edu 

                        Human Tissue Study 

                        • What kind of research is this? A study to test for changes in proteins and genes in tissue samples from the brain taken during epilepsy surgery 
                        • Who is this for? Children between 4 and 13 years old with epilepsy and who will undergo epilepsy surgery 
                        • Who is the doctor in charge of this study? James Wheless, MD 

                        Status: We are currently looking for patients for this study 

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Kenishia Guy, 901.287.7484, Kenishia.Guy@lebonheur.org 

                        International Pediatric Stroke Study (IPSS) 

                        • What kind of research is this? A registry of data to be collected from children across the world who are at high risk for stroke or who have already had a stroke 
                        • Who is this for? Children from birth to 18 years old who have been diagnosed with stroke or a condition or disease that may put them at a high risk of stroke  
                        • Who is the doctor in charge of this study? Tracee Ridley-Pryor, DNP, APRN, PMHNP-BC  

                        Status: We are currently looking for patients for this study 

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Sarah Barve, 901.287.7467, sarah.barve@lebonheur.org 

                        Low-Frequency TMS Treatment for Refractory Complex Partial Epilepsy  

                        • What kind of research is this? A study of a test called low-frequency transcranial magnetic stimulation (TMS) for detecting complex partial epilepsy 
                        • Who is this for? Patients who are 5 years old or older who have epilepsy that is difficult to treat (refectory epilepsy) with patients seizures (seizures that affect only a part of the brain) 
                        • Who is the doctor in charge of this study? Shalini Narayana, PhD 

                        Status: We are currently looking for patients for this study 

                        If you are interested in enrolling or would like more information, please contact Dr. Shalini Narayana, 901.287.4616, snaraya2@uthsc.edu 

                        MONARCH (Stoke Therapeutics) 

                        • What kind of research is this? A study of a medicine called STK-001 used to treat Dravet Syndrome 
                        • Who is this for? Children and adolescents between 2 and 18 years old who have been diagnosed with Dravet Syndrome 
                        • Who is the doctor in charge of this study? James Wheless, MD  

                        Status: Active not recruiting

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Sarah Barve, 901.287.7467, sarah.barve@lebonheur.org 

                        ClinicalTrials.gov information:  

                        Nelli - Detection of Paroxysmal Events Utilizing Computer Vision and Machine Learning

                        • What kind of research is this? A study to use machine learning to teach a system named Nelli how to detect seizures from video recordings of patients before they occur  
                        • Who is this for? Children and adolescents 6 and 21 years old who have a history (or a suspected history) of seizures who are scheduled to undergo routine video-EEG monitoring 
                        • Who is the doctor in charge of this study? James Wheless, MD  

                        Status: We are currently looking for patients for this study 

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Nick Leal, 901.287.5886, nicolas.leal@lebonheur.org

                        Novel Side Positioner Vest Device Trial  

                        • What kind of research is this? A study of a vest that can be used for positioning infants on their side to prevent or treat head flattening (occipital plagiocephaly) 
                        • Who is this for? Healthy infants 1 to 10 months of age 
                        • Who is the doctor in charge of this study? Stephanie Einhaus, MD  

                        Status: We are currently looking for patients for this study 

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Brandy Vaughn, 901.287.5892, brandy.vaughn@lebonheur.org

                        ORCHID Study

                        • What kind of research is this? A study to use a new medication called Fenfluramine to treat children and adolescents who have Dravet syndrome
                        • Who is this for?Infants between 1 to 2 years old 
                        • Who is the doctor in charge of this study? James Wheless, MD 

                        Status: We are currently looking for patients for this study.

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Kenishia Guy, 901.287.7484, Kenishia.Guy@lebonheur.org.

                        ClinicalTrials.gov information:  

                        • Official Name: A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome (ORCHID)
                        • Identifier: NCT02744677 (https://clinicaltrials.gov/study/NCT06118255

                        Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy 

                        • What kind of research is this? A study of a medicine called Valtoco for treating epilepsy 
                        • Who is this for? Children 2 to 5 years old with a clinical diagnosis of epilepsy 
                        • Who is the doctor in charge of this study? James Wheless, MD 

                        Status: Active not recruiting

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Misha Webb, 901.287.5330, Misha.Webb@lebonheur.org 

                        ClinicalTrials.gov information:  

                        PRAX-222 in Pediatric Participants with Early Onset SCN2A Development and Epileptic Encephalopathy

                        • What kind of research is this? A study of a new medicine called PRAX-222 that may control seizures in children who have a genetic alteration of the SCN2A gene.
                        • Who is this for? Children 2 to 18 years old who had seizures before reaching the age of 3 months, have a minimum weight of 22 pounds when they are screened, and had genetic testing done that discovered a variant in the SCN2A gene.
                        • Who is the doctor in charge of this study? James Wheless, MD

                        Status: Active not recruiting

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Misha Webb, 901.287.5330, Misha.Webb@lebonheur.org.

                        ClinicalTrials.gov information:

                        Seizures and Children’s Outcomes After Stroke (SCOUTS)

                        • What kind of research is this? This study will look at brain injuries that infants, children, and adolescents suffer after a stroke that may lead to developing seizures in the short term and epilepsy in the long term
                        • Who is this for? Patients who experienced a stroke between 28 days of age and 18 years of age who were enrolled in the Vascular Effects of Infection in Pediatric Stroke (VIPS) I or II studies
                        • Who is the doctor in charge of this study? Beth Anne Cavanaugh, MD

                        Status: We are currently looking for patients for this study

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Kenishia Guy, 901.287.7484, Kenishia.Guy@lebonheur.org.

                          

                        SKIP 025 

                        • What kind of research is this? A study using a medicine called Cenobamate with other treatments to treat generalized tonic-clonic seizures 
                        • Who is this for? Children 12 years or older who have primary generalized tonic-clonic seizures 
                        • Who is the doctor in charge of this study? James Wheless, MD 

                        Status: We are currently looking for patients for this study 

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Sarah Barve, 901.287.7467, sarah.barve@lebonheur.org 

                        ClinicalTrials.gov information:  

                        Skip 039 

                        • What kind of research is this? A study of a medicine called Cenobamate for treating partial-onset (or focal) seizures 
                        • Who is this for? Children and adolescents 2 to 18 years old with partial-onset seizures 
                        • Who is the doctor in charge of this study? James Wheless, MD 

                        Status: We are currently looking for patients for this study 

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Misha Webb, 901.287.5330, Misha.Webb@lebonheur.org 

                        ClinicalTrials.gov information:  

                        Skip 040 

                        • What kind of research is this? A study of a medicine called Cenobamate for treating partial-onset (or focal) seizures 
                        • Who is this for? Children and adolescents 2 to 18 years old with partial-onset seizures 
                        • Who is the doctor in charge of this study? James Wheless, MD 

                        Status: We are currently looking for patients for this study 

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Misha Webb, 901.287.5330, Misha.Webb@lebonheur.org 

                        Swallowtail (Stoke Therapeutics) 

                        • What kind of research is this? A study of a medicine called STK-001 to treat Dravet Syndrome 
                        • Who is this for? Children 2-and-a-half years old and older who have Dravet Syndrome and who participated in a previous study of STK-001 
                        • Who is the doctor in charge of this study? James Wheless, MD 

                        Status: Active not recruiting

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Sarah Barve, 901.287.7467, sarah.barve@lebonheur.org 

                        ClinicalTrials.gov information:  

                        • Official Name: An Open-Label Extension Study of STK-001 for Patients With Dravet Syndrome 

                        TrustTSC  

                        • What kind of research is this? A study of a medicine called ganaxolone for treating seizures associated with Tuberous Sclerosis Complex (TSC) 
                        • Who is this for? Patients aged 1 through 65 years old with a diagnosis of Tuberous Sclerosis Complex (TSC)-related Epilepsy. 
                        • Who is the doctor in charge of this study? Sarah Weatherspoon, MD

                        Status: We are currently looking for patients for this study 

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Kenishia Guy, 901.287.7484, Kenishia.Guy@lebonheur.org.

                        ClinicalTrials.gov information:  

                        • Official Name: Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy (TrustTSC) 

                        TSC Alliance Tuberous Sclerosis Complex (TSC) Biosample Repository and Natural History Database  

                        • What kind of research is this? A registry of data and samples to be collected from patients with Tuberous Sclerosis Complex (TSC) 
                        • Who is this for? Child and adult patients with a diagnosis Tuberous Sclerosis Complex (TSC). 
                        • Who is the doctor in charge of this study? James Wheless, MD 

                        Status: We are currently looking for patients for this study 

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Nick Leal, 901.287.5886, nicolas.leal@lebonheur.org 

                        UCB EP0162 

                        • What kind of research is this? A study of a medicine called Alprazolam for patients with stereotypical prolonged seizures 
                        • Who is this for? Adolescents 12 years old or older who have stereotypical prolonged seizures 
                        • Who is the doctor in charge of this study? Basanagoud Mudigoudar, MD  

                        Status: We are currently looking for patients for this study 

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Kenishia Guy, 901.287.7484, Kenishia.Guy@lebonheur.org 

                        ClinicalTrials.gov information:  

                        • Official Name: A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures 
                        • Identifier: NCT05077904 (https://beta.clinicaltrials.gov/study/NCT05077904 

                        UCB EP0165  

                        • What kind of research is this? A study of a medicine called Alprazolam for patients with stereotypical prolonged seizures 
                        • Who is this for? Adolescents 12 years old or older who have stereotypical prolonged seizures 
                        • Who is the doctor in charge of this study? Basanagoud Mudigoudar, MD 

                        Status: We are currently looking for patients for this study 

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Kenishia Guy, 901.287.7484, Kenishia.Guy@lebonheur.org 

                        Zogenix 2103  

                        • What kind of research is this? A study of a medicine called Zx008 to treat a genetic illness called Cdkl5 Deficiency Disorder (CDD) 
                        • Who is this for? Child and adult patients from 1 to 35 years old with a likely or confirmed mutation in the CDKL5 gene and a clinical diagnosis of CDD; patients will also need to have experienced epilepsy onset in the first year of life with motor and 
                        • developmental delays 
                        • Who is the doctor in charge of this study? James Wheless, MD  

                        Status: We are currently looking for patients for this study 

                        If you are interested in enrolling or would like more information, please contact the study coordinator: Kenishia Guy, 901.287.7484, Kenishia.Guy@lebonheur.org 

                        ClinicalTrials.gov information:  

                          Physical Activity as a Vital Sign in Mid-South Youth

                          • What kind of research is this? A study to use physical activity to monitor and improve physical and mental health and prevent chronic diseases like diabetes in adulthood.

                          • Who is this for? Any child between 6 to 18 years old who has come to Le Bonheur for a non-emergency medical issue; the child must be able to answer questions in a questionnaire and participate in physical activity.

                          • Who is the doctor in charge of this study? Webb Smith, PhD

                          Status: We are currently looking for patients for this study 

                          If you are interested in enrolling or would like more information, please contact the study coordinator: Savannah Blackwell, 901.287.6869, sblackw8@uthsc.edu.

                          Bracing vs Casting in the Treatment of Idiopathic Early-Onset Scoliosis  

                          • What kind of research is this? A study to compare casting and bracing for treating idiopathic early onset scoliosis (IEOS) 
                          • Who is this for? Children with a diagnosis of idiopathic early-onset scoliosis 
                          • Who is the doctor in charge of this study? Derek Kelly, MD  

                          Status: We are currently looking for patients for this study 

                          If you are interested in enrolling or would like more information, please contact the study coordinator: Jonathan Rowland, 901.287.6856, Jonathan.Rowland@lebonheur.org 

                          Does the Use of Complementary Alternative Medicine in Adolescents with Idiopathic Scoliosis Undergoing Posterior Spinal Fusion Improve Patient Outcomes? 

                          • What kind of research is this? A study of a natural supplement (aromatherapy oil blend) called QueaseEASE to help with nausea after spinal fusion surgery for idiopathic scoliosis 
                          • Who is this for? Adolescents and adults from 12 to 21 years old who have idiopathic scoliosis and are undergoing initial posterior spinal fusion 
                          • Who is the doctor in charge of this study? Lindsey N. Locke, MSN, CPNP-PC  

                          Status: We are currently looking for patients for this study 

                          If you are interested in enrolling or would like more information, please contact the study coordinator: Jonathan Rowland, 901.287.6856, Jonathan.Rowland@lebonheur.org 

                          Evaluation of Conventional Strap Tension, Constant-Tension Units, and a Modified Brace for Adolescent Idiopathic Scoliosis (AIS) 

                          • What kind of research is this? A study of current bracing technology to assist in the development of a new treatment called the Constant Tension Unit (CTU) 
                          • Who is this for? Children and adolescents 5 to 17 years old who have been diagnosed with Idiopathic Scoliosis 
                          • Who is the doctor in charge of this study? Denis DiAngelo, PhD (no biography webpage) 

                          Status: We are currently looking for patients for this study 

                          If you are interested in enrolling or would like more information, please contact the study coordinator: Jonathan Rowland, 901.287.6856, Jonathan.Rowland@lebonheur.org 

                          Hospital-Based Cluster Stratified Randomization Control Trial: Determination of Best MCGR Implementation Strategy Using Distraction Intervals  

                          • What kind of research is this? A study to see if shorter intervals (6 weeks) between magnetically controlled growing rod (MCGR) lengthenings work better than the standard interval (16 weeks) 
                          • Who is this for? Children 5 to 9 years old who have been diagnosed with Early Onset Scoliosis (EOS) and are planning to undergo initial MCGR implantation
                          • Who is the doctor in charge of this study? Jeffrey Sawyer, MD  

                          Status: We are currently looking for patients for this study 

                          If you are interested in enrolling or would like more information, please contact the study coordinator: Jonathan Rowland, 901.287.6856, Jonathan.Rowland@lebonheur.org 

                          Scoliosis Analog Model for Evaluation of Bracing Technology  

                          • What kind of research is this? A study to improve current bracing technology for scoliosis and develop a new and better brace 
                          • Who is this for? Children and adolescents 5 to 17 years old who have been diagnosed with Idiopathic Scoliosis 
                          • Who is the doctor in charge of this study? Denis DiAngelo, PhD 

                          Status: We are currently looking for patients for this study 

                          If you are interested in enrolling or would like more information, please contact the study coordinator: Jonathan Rowland, 901.287.6856, Jonathan.Rowland@lebonheur.org 

                          • No current trials available. Please check back later.

                          Assessing Effectiveness and Implementation of a Perioperative Enhanced Recovery Protocol for Children Undergoing Gastrointestinal Surgery (ENRICH-US) 

                          • What kind of research is this? A survey study of patients and the parents of patients on the best way to care for children before, during, and after gastrointestinal surgery  
                          • Who is this for? Children and adolescents 10 to 18 years old who are scheduled to undergo non-emergency (elective) gastrointestinal surgery  
                          • Who is the doctor in charge of this study? Tim Jancelewicz, MD, MA, MS, FAAP, FACS  

                          Status: We are currently looking for patients for this study 

                          If you are interested in enrolling or would like more information, please contact the study coordinator: Lauren Camp, 901.287.4449, lauren.camp@lebonheur.org 

                          More information about this study can be found on the ENRICH-US Website: https://enrich-us.org/

                          PediAtric ReseArch of Drugs, Immunoparalysis and Genetics during MODS (PARADIGM)

                          • What kind of research is this? A multi-center study to understand how the immune system works in children who are very sick with at least two organs that aren't working well. Knowing how a child’s diagnosis, treatments, and genes relate to their immune system function may help us design better treatments for critically ill children in the future.
                          • Who is this for?Babies and children from 0 to 17 years old with multiple organ dysfunction syndrome (MODS) who are admitted to the PICU
                          • Who is the doctor in charge of this study? Samir Shah, MD, MBA

                            Status: We are currently looking for patients for this study 

                            If you are interested in enrolling or would like more information, please contact the study coordinator: Alyssa Marie Kintanar, 901.287.5044, alyssamarie.kintanar@lebonheur.org.

                            P-ICECAP (Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients)

                            • What kind of research is this? This is a study to see if cooling patients down for different lengths of time may help with brain function in children who are in a coma because of cardiac arrest.
                            • Who is this for? Children from 2 days old up to 18 years old who are in coma after suffering cardiac arrest outside of a hospital setting and have been admitted to the intensive care unit. (Patients must also be enrolled within 6 hours following their cardiac arrest.)
                            • Who is the doctor in charge of this study? Alexandra Schaller, DO

                              Status: We are currently looking for patients for this study 

                              If you are interested in enrolling or would like more information, please contact the study coordinator: Laura Boywid, 901.491.4915 or 901.287.5230, laura.boywid@lebonheur.org.

                              ClinicalTrials.gov information:

                              Biomarkers of Brain Injury in Children on Extracorporeal Membrane Oxygenation (BEAM Study)

                              • What kind of research is this? A study of patients on extracorporeal membrane oxygenation (ECMO) to find markers in the blood that the medical team can use to check brain injury.
                              • Who is this for? Children at least 2 days and under 18 years old who are in an intensive care unit (ICU).
                              • Who is the doctor in charge of this study? Hitesh Sandhu, MB, BS, MRCPCH

                                Status: Active, not recruiting

                                If you are interested in enrolling or would like more information, please contact A. Nico West, MD, 901.287.6303, awest3@uthsc.edu.

                                ClinicalTrials.gov information:

                                Prone and Oscillation Pediatric Clinical Trial (PROSpect) 

                                • What kind of research is this? A study compare lying on one's back or stomach when off a ventilater, and to compare high-frequency oscillatory ventilation (HFOV) with conventional mechanical ventilation (CMV) on ventilator-free days when off a ventilater 
                                • Who is this for? Critically ill pediatric patients with moderate-severe Pediatric Acute Respiratory Distress Syndrome (PARDS)  
                                • Who is the doctor in charge of this study? Hitesh Sandhu, MBBS, MRCPCH  

                                Status: We are currently looking for patients for this study 

                                If you are interested in enrolling or would like more information, please contact the study coordinator: Laura Boywid, 901.287.5230, laura.boywid@lebonheur.org 

                                  • No current trials available. Please check back later.

                                  Effect of Restricted Fluid Management Strategy on Outcomes in Critically Ill Pediatric Trauma Patients

                                  • What kind of research is this? This study will look at how much intravenous (IV) fluid should be given to children with traumatic injuries after surgery.
                                  • Who is this for? Children who have experienced trauma, were admitted to the pediatric intensive care unit (PICU) and had surgery.
                                  • Who is the doctor in charge of this study? Regan Williams, MD

                                  Status: We are currently looking for patients for this study

                                  If you are interested in enrolling or would like more information, please contact the study coordinator: Jincy Rajan, 901.287.6859, jincy.rajan@mlh.org.  

                                  Operative vs. Non-Operative Management of Pancreatic Injuries in the Pediatric Population

                                  • What kind of research is this? This study will find out if surgery or medical care is the best choice for children who have suffered an injury to the body that also injured the pancreas and damaged the duct inside the pancreas.
                                  • Who is this for? Children between 0 and 17 years old who have had a blunt traumatic injury to the body that also affected the pancreas and pancreatic duct.
                                  • Who is the doctor in charge of this study? Rachel Landisch, MD

                                  Status: We are currently looking for patients for this study

                                  If you are interested in enrolling or would like more information, please contact the study coordinator: Jincy Rajan, 901.287.6859, jincy.rajan@mlh.org.


                                    Updated November 2023