Research
Clinical Research
Our physicians and support staff work tirelessly to ensure safety and efficacy of medication and other treatment regimens meant to prevent and treat diseases in the pediatric and adolescent population.
Below, please find some highlights from the clinical research happening in our divisions.
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- Heather Agazzi, PhD: Her research interests include evaluation, diagnosis, and treatment of developmental disabilities, disruptive behavior disorders, and adverse childhood experiences.
She is currently Site PI/Co-PI/Co-I for the following studies:
- Behavioral Health Workforce Education & Training Program at USF, funded by the Health Resources & Services Administration (HRSA), United States Department of Health
- An Integrated Nutrition Intervention through the Part C Early Intervention Services to Promote Healthy Eating Habits for Children with Autism Spectrum Disorders (NIH)
- DOCS Parenting Program
For more information on HOT DOCS and DOCS K-5, visit https://health.usf.edu/medicine/pediatrics/child-development/hotdocs/overview.
- Heather Agazzi, PhD: Her research interests include evaluation, diagnosis, and treatment of developmental disabilities, disruptive behavior disorders, and adverse childhood experiences.
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- Christopher Griffith, MD: His research interests include Fabry, Pompe, and Gaucher.
His current studies include:
- Sanofi Genzyme Rare Disease Registry - A Multi-Center, International, Longitudinal, Observational program designed to track natural history and outcomes of patients with Gaucher, Fabry, MPSI, and Pompe Disease (Gaucher registry, Fabry registry, MPSI registry, Pompe registry)
- A Phase I/II, Multicenter, Open-Label, Single-Dose, Dose-Ranging Study to Assess the Safety and Tolerability of ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy in Subjects with Fabry Disease
- Amarilis Sanchez-Valle, MD: Her research
interests include inborn errors of metabolism, specifically, Phenylketonuria,
Fatty Acid Oxidation Disorders, and Urea Cycle Disorders.
She is currently the site PI for the following studies:
- A Phase 1/2 Open-Label, Dose Escalation Study to Determine the Safety and Efficacy of BMN 307, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Phenylalanine Hydroxylase in Subjects with Phenylketonuria and Plasma Phe Levels > 600 μmol/L
- Long-Chain Fatty Acid Oxidation Disorders In-Clinic Disease Monitoring Program
- A Phase 3 Multi-Center Study to Evaluate the Safety and Efficacy of Subcutaneous Injections of Pegvaliase in Adolescent Subjects (Ages 12-17) with Phenylketonuria Featuring an Open-Label Randomized Two-Arm (Active vs. Diet-Only Control) Design
- An Observational, Longitudinal, Prospective, Long-Term Registry of Patients with hypophosphatasia
- A Prospective Study Investigating the Natural History of Adults with Phenylketonuria (PKU) due to Phenylalanine Hydroxylase Deficiency
- A Non-Interventional Post-Authorization Safety Study (PASS) of Carbaglu® for the Treatment ofHyperammonemia Due to Methylmalonic Acidemia (MMA) and Propionic Acidemia (PA)in Adult and Pediatric Patient Populations
- A Phase 1, First-In-Human, Multiple Part, Single Ascending and Multiple Dose Study of JNT-517 in Healthy Participants and in Participants with Phenylketonuria
- A Non-Interventional Observational Study of Pegvaliase-Naïve Adults with Phenylketonuria (PKU): Concept Elicitation and Cognitive Interviews
- Christopher Griffith, MD: His research interests include Fabry, Pompe, and Gaucher.
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- Carina A. Rodriguez, MD: Her research interests
include HIV/STI prevention and treatment, vaccinology, infections in
immunocompromised patients and tuberculosis.
She is currently site PI or Co-PI for NIH-funded national and international networks including:
- COVID-19 Prevention Network (CoVPN)
- The Congenital and Perinatal Rare Disease Clinical Research Consortium
- The Adolescent Trials Networks
Her other active studies include:
- ACTG A5418 NIH/NIAID: A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease.
- Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Site Consortium related protocols
- A Phase 3 open-label expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273.214 primary and booster SARS-CoV-2 vaccine in healthy children 6 months to less than 6 years of age
- A Phase 2/3, two part, open-label, dose-escalation and randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273 SARS-CoV-2 vaccine in healthy children 6 months to less than 12 years of age
- A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 12- to 30-year old Healthy Adolescents and Adults
- Congenital and Perinatal Rare Disease Clinical Research Consortium relates protocols on acute flaccid myelitis, neonatal enterovirus, cytomegalovirus infections or their treatments.
- Phase 1/ 2 Study of Switching to Fixed Dose Combination Dolutegravir/Rilpivirine among Virologically Suppressed Children 6 to less than 12 years of age, Living with HIV-1
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Claudia Espinosa, MD, MSc: Her research interests include perinatal infections, surveillance of
respiratory infections, and infection prevention.
She is currently PI for the following studies:
- A neonatal enterovirus ad human parechovirus viral sepsis study to define the natural history and predictors of morbidity and mortality of these infections in neonates NIAID/University Cincinnati
- A prospective study of Acute Flaccid Myelitis to define natural history, risk factors, and pathogenic mechanisms of this disease. UAB/NIH
- A phase 2 randomized, double blind, placebo-controlled, study to evaluate an antiviral in children infected with RSV
- A phase 3, multicenter, randomized, partially blinded, palivizumab controlled study to evaluate the safety, efficacy, and pharmacokinetics of a monoclonal antibody in infants and children at increased risk for severe RSV disease
- A Multicenter, Open-Label, Evaluator-Blinded, Randomized Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin versus Standard of Care for the Treatment of Pediatric Subjects with Acute Bacterial Skin and Skin Structure Infections
- Carina A. Rodriguez, MD: Her research interests
include HIV/STI prevention and treatment, vaccinology, infections in
immunocompromised patients and tuberculosis.
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- Maya Balakrishnan, MD: Her research interests include quality improvement, its clinical applications, as well as its effectiveness on neonatal abstinence syndrome.
She is currently Site Co-I for the following studies:
- Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal
Syndrome (ACT NOW ESC): A function-based assessment and management approach
(NIH, NICHD)
- Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal
Syndrome (ACT NOW ESC): A function-based assessment and management approach
(NIH, NICHD)
- Jaime Flores-Torres, MD: His research interests include Hypoxic Ischemic Encephalopathy, neonatal seizures, prenatal consultation, and neonatal palliative care.
He is currently Site PI for the following clinical trials:
- Infant Bacterial
Therapeutics AB – IBP9414-020: A randomized, double blind, parallel-group,
placebo-controlled study to evaluate the efficacy and safety of IBP-9414 in
premature infants 500-1500g birth weight in the prevention of necrotizing
enterocolitis – The Connection study
- Infant Bacterial
Therapeutics AB – IBP9414-020: A randomized, double blind, parallel-group,
placebo-controlled study to evaluate the efficacy and safety of IBP-9414 in
premature infants 500-1500g birth weight in the prevention of necrotizing
enterocolitis – The Connection study
- Steven Ford, MD: His research interests include
neonatal nutrition and intestinal rehabilitation.
He is currently Site PI for the following clinical trials:
- Oak Hill Bio- OHB-607-202, A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age Compared to Standard Neonatal Care in Extremely Premature Infants
- Abbott Nutrition, Abbott Laboratories, AL-46, Growth and Tolerance of Premature Infants Fed an Experimental Human Milk Fortifier
- Thao (Tina) Ho, DO: Her research interests include the development of gut microbiota, its influence on health
and impact on risk for diseases in preterm infants.
She is currently Site PI for the following studies:
- Enteral Iron Dosage and Gut Health: A Randomized Double Blinded Study (NIH, NHLBI: 5K23HL150300) Anemia and Gut Microbiota: An Observational Study
- The Effect of Anemia and Maternal Factors on Intestinal Microbiome in VLBW Infants: An Observational Study
- An AI-based Multimodal Approach for Monitoring Prolonged Acute Pain in Neonates: An Observational Study
- Tara Randis, MD: Her research interests include the
mechanisms by which maternal pathogens contribute to adverse pregnancy outcomes and neonatal morbidity and mortality.
She is currently Site PI for the following studies:
- NICU Antibiotics and Outcomes Trial (NIH, NICHD)
- Tanner Wright, MD: His research interests include maternal-infant dyads affected by opioid use.
He is currently Site PI/Co-PI for the following studies:
- ACT NOW Weaning study (NIH), Pragmatic, Randomized, Blinded Trial to Shorten Pharmacologic Treatment of Newborns with Neonatal Opioid Withdrawal Syndrome (NOWS)
- Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal Syndrome (ACT NOW ESC): A function-based assessment and management approach (NIH, NICHD)
- MATernal and Infant Network to Understand Outcomes Associated with Treatment for Opioid Use Disorder during Pregnancy (MAT-LINK 2) Expansion Project (CDC, PHII)
- Adverse Childhood Experiences: Impact on Maternal and Infant Outcomes Associated with Opioid Use Disorder USF Women’s Health Collaborative- PNC Bank Sponsored Seed Grant
- CADENCE-ContinuousAndData-drivENCarE” (NIH-NIDA)
- Program to Reduce Severe Maternal Morbidity through Telehealth (SMMT) in Florida
- Maya Balakrishnan, MD: Her research interests include quality improvement, its clinical applications, as well as its effectiveness on neonatal abstinence syndrome.
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- Adam B. Lewin, PhD, ABPP: His research interests include Tourette, Obsessive Compulsive, Misophonia, and related disorders.
He is currently Site PI for the following grants:
- Transdiagnostic Treatment for Youth with Misophonia (Clinical Trial; Funded by the Ream Foundation)
- Screening for Tourette and Tic Disorders (Funded by CDC)
- Applying Statistical Measures to Improve identification of Tics and Tic Disorders (Funded by CDC)
- Developing assessment tools for Misophonia (Funded by the Ream Foundation)
- Adam B. Lewin, PhD, ABPP: His research interests include Tourette, Obsessive Compulsive, Misophonia, and related disorders.