Author: Kayla Korzekwinski

Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative

Posted on by Kayla Korzekwinski

Contemporary Clinical Trials Communications • November 2017

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Greenberg RG, Corneli A, Bradley J, Farley J, Jafri HS, Lin L, Nambiar S, Noel GJ, Wheeler C, Tiernan R, Smith PB, Roberts J, Benjamin DK Jr.

Despite legislation to stimulate pediatric drug development through clinical trials, enrolling children in trials continues to be challenging. Non-investigator providers are essential to recruitment of pediatric patients, but little is known regarding the specific barriers that limit pediatric providers from participating in and referring their patients to clinical trials. This study conducted an online survey of pediatric providers from a wide variety of practice types across the United States to evaluate their attitudes and awareness of pediatric clinical trials.

Association between early echocardiography, therapy for patent ductus arteriosus, and outcomes in very low birth weight infants

Posted on by Kayla Korzekwinski

Cardiology in the Young • November 2017

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Lee JH, Greenberg RG, Quek BH, Clark RH, Laughon MM, Smith PB, Hornik CP

In very low birth weight infants, persistence of a patent ductus arteriosus results in morbidity and mortality. Therapies to close the ductus are effective, but clinical outcomes may depend on the accuracy of diagnosis and the timing of administration. The objective of the present study was to characterise the association between early echocardiography, therapy for patent ductus arteriosus, and outcomes in very low birth weight infants.

Population Pharmacokinetics of Dexmedetomidine in Infants

Posted on by Kayla Korzekwinski

Journal of Clinical Pharmacology • September 2017

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Greenberg RG, Wu H, Laughon M, Capparelli E, Rowe S, Zimmerman KO, Smith PB, Cohen-Wolkowiez M

Despite limited pharmacokinetic (PK) data, dexmedetomidine is increasingly being used off-label for sedation in infants. This study aimed to characterize the developmental PK changes of dexmedetomidine during infancy.

Antifungal Extraction by the Extracorporeal Membrane Oxygenation Circuit

Posted on by Kayla Korzekwinski

The Journal of ExtraCorporeal Technology • September 2017

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Watt KM, Cohen-Wolkowiez M, Williams DC, Bonadonna DK, Cheifetz IM, Thakker D, Benjamin DK Jr, Brouwer KLR

Invasive candidiasis is common and often fatal in patients supported with extracorporeal membrane oxygenation (ECMO), and treatment relies on optimal antifungal dosing. The ECMO circuit can extract drug and decrease drug exposure, placing the patient at risk of therapeutic failure. This ex vivo study determined the extraction of antifungal drugs by the ECMO circuit. Fluconazole and micafungin were studied separately in three closed-loop circuit configurations to isolate the impact of the oxygenator, hemofilter, and tubing on circuit extraction.

Use of Population Pharmacokinetics and Electronic Health Records to Assess Piperacillin-Tazobactam Safety in Infants

Posted on by Kayla Korzekwinski

The Pediatric Infectious Disease Journal • September 2017

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Salerno S, Hornik CP, Cohen-Wolkowiez M, Smith PB, Ku LC, Kelly MS, Clark R, Gonzalez D; Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee.

Piperacillin, in combination with tazobactam, is frequently used in infants for treating nosocomial infections, although safety data in this population are limited. Electronic health record (EHR) data can be used to evaluate drug safety in infants, but measures of drug exposure are lacking. To relate simulated piperacillin exposure with adverse events (AEs) in infants using EHR data, we identified infants discharged from 333 neonatal intensive care units managed by the Pediatrix Medical Group between 1997 and 2012.

Population Pharmacokinetics and Exploratory Pharmacodynamics of Lorazepam in Pediatric Status Epilepticus

Posted on by Kayla Korzekwinski

Clinical Pharmacokinetics • August 2017

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Gonzalez D, Chamberlain JM, Guptill JT, Cohen-Wolkowiez M, Harper B, Zhao J, Capparelli EV; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee.

Lorazepam is one of the preferred agents used for intravenous treatment of status epilepticus (SE). We combined data from two pediatric clinical trials to characterize the population pharmacokinetics of intravenous lorazepam in infants and children aged 3 months to 17 years with active SE or a history of SE.

Late-onset Sepsis in Extremely Premature Infants: 2000-2011

Posted on by Kayla Korzekwinski

The Pediatric Infectious Disease Journal • August 2017

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Greenberg RG, Kandefer S, Do BT, Smith PB, Stoll BJ, Walsh MC, Bell EF, Carlo WA, Laptook AR, Sánchez PJ, Shankaran S, Van Meurs KP, Ball MB, Hale EC, Newman NS, Das A, Higgins RD, Cotton CM, for the Eunice Kennedy Shriver National Institute of Child Health

Late-onset sepsis (LOS) is an important cause of death and neurodevelopmental impairment in premature infants. The purpose of this study was to assess overall incidence of LOS, distribution of LOS-causative organisms and center variation in incidence of LOS for extremely premature infants over time.

In-hospital outcomes of premature infants with severe bronchopulmonary dysplasia

Posted on by Kayla Korzekwinski

Journal of Perinatology • July 2017

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Jackson W, Hornik CP, Messina J, Guglielmo K, Watwe A, Delancy G, Valdez A, MacAuthur T, Peter-Wohl S, Smith PB, Clark R, Laughon MM

This study characterized in-hospital outcomes of premature infants diagnosed with severe bronchopulmonary dysplasia (BPD). A majority of infants diagnosed with severe BPD were discharged home by 44 weeks of postmenstrual age. These results may inform discussions with families regarding the expected hospital course of infants diagnosed with severe BPD.

Timing of Multiorgan Dysfunction among Hospitalized Infants with Fatal Fulminant Sepsis

Posted on by Kayla Korzekwinski

American Journal of Perinatology • June 2017

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Wynn JL, Kelly MS, Benjamin DK, Clark RH, Greenberg R, Benjamin DK Jr, Smith PB

This study sought to identify the progression of specific signs of multiorgan dysfunction among infants with fatal sepsis. Hospitalized infants with fatal LOS manifest respiratory, cardiovascular, renal, immune, and hematologic dysfunction. Knowledge of these factors and their timing may be important for the development and testing of novel therapeutics to reduce sepsis mortality.

Risk Factors and In-Hospital Outcomes Following Tracheostomy in Infants

Posted on by Kayla Korzekwinski

The Journal of Pediatrics • June 2017

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Lee JH, Smith PB, Quek MBH, Laughon MM, Clark RH, Hornik CP

This study analyzed an electronic medical record from 348 NICUs from 1997–2012 and evaluated the associations between infant demographics, diagnoses, and pre-tracheostomy cardio-pulmonary support with in-hospital mortality. It also determined the trends in use of infant tracheostomy over time. Tracheostomy is uncommonly performed in hospitalized infants, but the associated mortality is high. Risk factors for increased in-hospital mortality after tracheostomy include GA near term, SGA, and pulmonary diagnoses.