Study Population

Application of Physiologically Based Pharmacokinetic Modeling to Characterize the Effects of Age and Obesity on the Disposition of Levetiracetam in the Pediatric Population

Posted on by Kayla Korzekwinski

Clinical Pharmacokinetics • June 2024

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Maglalang PD, Sinha J, Zimmerman K, McCann S, Edginton A, Hornik CP, Hornik CD, Muller WJ, Al-Uzri A, Meyer M, Chen L, Anand R, Perrin E, Gonzalez D., Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee

Levetiracetam is an antiseizure medication used for several seizure types in adults and children aged 1 month and older; however, due to a lack of data, pharmacokinetic (PK) variability of levetiracetam is not adequately characterized in certain populations, particularly neonates, children younger than 2 years of age, and children older than 2 years of age with obesity. PBPK modeling simulations revealed that the current US FDA-labeled pediatric dosing regimen listed in the prescribing information can produce the required exposure of levetiracetam in these target populations with dose adjustments for children with obesity aged 4 years to younger than 16 years.

Urinary Tract Infection Epidemiology in NICUs in the United States

Posted on by Kayla Korzekwinski

American Journal of Perinatology • May 2024

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Kilpatrick R, Boutzoukas AE, Chan E, Girgis V, Kinduelo V, Kwabia SA, Yan J, Clark RH, Zimmerman KO, Greenberg RG

This study characterized the incidence, associated clinical factors, timing of infection, microbiology, and incidence of concordant blood culture of urinary tract infections (UTIs) in very low birth weight (VLBW <1,500g) infants. UTI is a common cause of infection in VLBW infants, especially among the smallest, most premature, male infants, and those with a longer duration of hospitalization. Neonatal clinicians should consider obtaining urine culture in the setting of late-onset sepsis evaluations in VLBW infants.

Opportunistic dried blood spot sampling validates and optimizes a pediatric population pharmacokinetic model of metronidazole

Posted on by Kayla Korzekwinski

Antimicrobial Agents and Chemotherapy • April 2024

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Randell RL, Balevic SJ, Greenberg RG, Cohen-Wolkowiez M, Thompson EJ, Venkatachalam S, Smith MJ, Bendel C, Bliss JM, Chaaban H, Chhabra R, Dammann CEL, Downey LC, Hornik C, Hussain N, Laughon MM, Lavery A, Moya F, Saxonhouse M, Sokol GM, Trembath A, Weitk

Pharmacokinetic models rarely undergo external validation in vulnerable populations such as critically ill infants, thereby limiting the accuracy, efficacy, and safety of model-informed dosing in real-world settings. Here, we describe an opportunistic approach using dried blood spots (DBS) to evaluate a population pharmacokinetic model of metronidazole in critically ill preterm infants of gestational age (GA) ≤31 weeks from the Metronidazole Pharmacokinetics in Premature Infants study.

Leveraging School Infection Data to Address Community COVID-19 Data Gaps

Posted on by Kayla Korzekwinski

Journal of the Pediatric Infectious Diseases Society • December 2023

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Moreda E, Al-Dhalimy H, Ha M, Nwanaji-Enwerem E, Nguyen A, Pieters K, Brookhart MA, Hickerson J, Benjamin, Jr DK, Zimmerman KO, Boutzoukas AE

At-home COVID-19 testing resulted in significant data gaps; K-12 data could have supplemented community data. In future public health emergencies, reporting of school data could minimize data gaps, but requires additional resources including funding to track infections and standardized data reporting methods.

Risk factors and epidemiology of spontaneous intestinal perforation among infants born at 22-24 weeks’ gestational age

Posted on by Kayla Korzekwinski

Journal of Perinatology • January 2024

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Thakkar PV, Sutton KF, Detwiler CAB, Henegar JG, Narayan JR, Perez-Romero M, Strausser CM, Clark RH, Benjamin DK Jr, Zimmerman KO, Goldberg RN, Younge N, Tanaka D, Smith PB, Greenberg RG, Kilpatrick R

This study sought to describe the epidemiology, risk factors, and timing of spontaneous intestinal perforation (SIP) among infants born at 22-24 weeks’ gestational age (GA). Antenatal magnesium exposure, antenatal indomethacin exposure, postnatal hydrocortisone exposure, postnatal indomethacin exposure, and weight loss ≥15% were associated with SIP.

Mentorship

Posted on by Kayla Korzekwinski

Journal of the Pediatric Infectious Diseases Society • December 2023

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Zimmerman KO

A unique feature of the Duke Summer Training in Academic Research (STAR) program is its focus on mentorship. STAR is an opportunity for junior faculty members and fellows to learn how to be mentors, and for undergraduate and high school students to learn how to be mentored. These are important and fundamental points; mentorship, from the perspective of mentor or mentee, should be a deliberate and skilled activity that can result from adequate training.

Association Between Hypoglycemia and the Occurrence of Early Onset Sepsis in Premature Infants

Posted on by Kayla Korzekwinski

Journal of the Pediatric Infectious Diseases Society • December 2023

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Kumar KR, Shah SJ, Fayyad RM, Turla TM, O’Sullivan LM, Wallace B, Clark RH, Benjamin Jr DK, Greenberg RG, Hornik CP

This study examined the association between hypoglycemia and the occurrence of early onset sepsis (EOS) in premature infants admitted to the neonatal intensive care unit (NICU). Hypoglycemia may be an early marker of EOS, particularly in episodes caused by Gram-negative organisms and when using a stricter definition of hypoglycemia.

Late-Onset Sepsis Evaluation and Empiric Therapy in Extremely Low Gestational Age Newborns

Posted on by Kayla Korzekwinski

Journal of the Pediatric Infectious Diseases Society • December 2023

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Speier RL, Cotton CM, Lewis K, Benajmin DK Jr, Keeler K, Kidimbu G, Roberts W, Clark RH, Zimmerman KO, Stark A, Greenberg RG

Little is known about late-onset sepsis (LOS) evaluations in extremely low gestational age newborns (ELGANs). This study describes frequencies of LOS evaluation in ELGANs, infant characteristics, and empiric therapy choices during evaluations.

Duke STAR Program

Posted on by Kayla Korzekwinski

Journal of the Pediatric Infectious Diseases Society • December 2023

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Benjamin DK Jr

The DCRI Pediatrics group designed a summer internship program that had a wide reach and reflects its purpose and mission to conduct research to help children everywhere. This led to the creation of the Duke STAR (Summer Training in Academic Research) Program, a program that provides ~20 high school or college students per summer the opportunity to be exposed to clinical research and to work closely with researchers and practicing clinicians. Recruiting efforts prioritized participants from historically marginalized communities in North Carolina, with a goal to include at least several students each year who were “hidden talent.”

Diagnostic Utility of Cerebrospinal Fluid White Blood Cell Components for the Identification of Bacterial Meningitis in Infants

Posted on by Kayla Korzekwinski

Journal of the Pediatric Infectious Diseases Society • December 2023

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Lamb AE, Rent S, Brannon AJ, Greer JL, Ndey-Bongo NP, Cho SH, Greenberg RG, Benjamin DK Jr, Clark RH, Kumar KR

This study evaluated the diagnostic and predictive utility of cerebrospinal fluid (CSF) white blood cell (WBC) components in the diagnosis of bacterial meningitis in infants discharged from the neonatal intensive care unit (NICU). No single clinical prediction rule had the optimal discriminatory power for predicting culture-proven bacterial meningitis, and clinicians should be cautious when interpreting CSF WBC parameters in infants with suspected meningitis.