Industry

Study Funding Source: Industry

Long-term Neurodevelopmental Effects in Neonates Following Treatment with Lacosamide

The Neurodevelopmental Outcomes Study is a retrospective, observational cohort study designed to compare the long-term neurocognitive outcomes of neonates treated with lacosamide versus other antiseizure medications (ASMs) for neonatal seizures. Neonatal seizures, which occur in 1.4 to 3.6 per 1,000 live births, are associated with poor neurodevelopmental outcomes, including cognitive delays and increased risk of […]

Long-term Neurocognitive Effects in Neonates Following Treatment with Lacosamide

The Neurocognitive Developmental Outcomes Study is a retrospective, observational cohort study designed to compare the long-term neurocognitive outcomes of neonates treated with lacosamide versus other antiseizure medications (ASMs) for neonatal seizures. Neonatal seizures, which occur in 1.4 to 3.6 per 1,000 live births, are associated with poor neurodevelopmental outcomes, including cognitive delays and increased risk […]

Characterization of Babies Born with Hemolytic Disease of the Fetus/Newborn (HDFN)

Hemolytic disease of the fetus and newborn (HDFN) otherwise known as erythroblastosis fetalis, is a disease in which fetal and neonatal erythrocytes are destroyed by maternal IgG alloantibodies. Before the first RhD immunoprophylaxis was introduced as a treatment in 1968, HDFN affected 1% of all newborns worldwide and resulted in a mortality rate of 50% […]

Health Services and Clinical Characteristics that Precede Diagnosis of Primary Hyperoxaluria Type 1

Primary hyperoxaluria (PH) encompasses 3 genetically distinct, autosomal-recessive, inborn errors of glyoxylate metabolism characterized by the over-production of oxalate, a highly insoluble metabolic endproduct that is eliminated mainly by the kidney. All 3 forms of PH exhibit some extent of overlap in the clinical manifestations, where overproduction of oxalate is a prominent observation. Renal oxalate […]

Hemolytic Disease of the Fetus and Newborn (HDFN) Epidemiology Study

The Hemolytic Disease of the Fetus and Newborn (HDFN) Epidemiology Study aims to analyze the epidemiology and clinical outcomes of HDFN using data from the PEDSnet database. HDFN, caused by maternal IgG alloantibodies that destroy fetal and neonatal erythrocytes, remains a critical concern despite advancements in prenatal care and prophylactic treatment. While Rh immunoprophylaxis has […]

NEST R1: Developing Capacity for Post Marketing Surveillance of Craniomaxillofacial Distractors

The National Evaluation System for health Technology Coordinating Center (NESTcc) is tasked to be a catalyst for the timely, reliable, and cost-effective development of real-world evidence (RWE) to enhance regulatory and clinical decision-making for medical devices. Real world data (RWD) reflects information relating to patient health status and the delivery of health care routinely collected […]

Skeletal and Cranial Growth Among Children with Achondroplasia

Achondroplasia, the most common form of disproportionate short stature, is caused by a mutation in the fibroblast growth factor receptor 3 (FGFR3) gene. Affected children may experience severely impaired foramen magnum growth during the first years of life, which may necessitate neurosurgical intervention. The skeletal abnormalities seen in achondroplasia can result in respiratory and neurologic […]

Evaluating the Occurrence of Adverse Events Among Pediatric Patients Exposed to IV Lacosamide Using RWD

Epilepsy affects the pediatric population with an estimated prevalence of 6.8 per 1,000 insured children. Newly introduced antiepileptic drugs (AEDs) may be used off-label in children with epilepsy before completion of pediatric regulatory studies, creating an opportunity to evaluate the real-world use and safety of these drugs in children to support the pediatric clinical trial […]

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