Duke STAR Program

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

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.

Trends in Pediatric Emergency and Inpatient Healthcare Use for Mental and Behavioral Health Among North Carolinians During the Early COVID-19 Pandemic

Journal of the Pediatric Infectious Diseases Society December 2023

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Sielaty R, Boutzoukas AE, Zimmerman KO, Caison B, Charles CO, CoyneSmith T, Darden T, Overman RA, Benjamin, Jr DK, Brookhart MA

Widespread school closures and health care avoidance during the COVID-19 pandemic led to disruptions in access to pediatric mental health care. This study conducted a retrospective analysis of emergency and inpatient administrative claims from privately insured children aged 6-20 years in North Carolina between January 2019 and December 2020.

Pharmacokinetics and Proposed Dosing of Levetiracetam in Children With Obesity

The Journal of Pediatric Pharmacology and Therapeutics December 2023

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Zimmerman KO, Wu H, Maharaj A, Turner A, Chen L, Hornik CD, Arnold S, Muller W, Al-Uzri A, Meyer M, Shiloh-Malawsky Y, Taravath S, Lakhotia A, Joshi C, Jackman J, Hornik CP; on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network

This study sought to characterize levetiracetam pharmacokinetics (PK) in children with obesity to inform dosing. Weight-tiered dosing for levetiracetam oral solution and tablets for children with obesity 4 to <16 years old results in more comparable exposures to children of normal weight.

Impact of the COVID-19 Pandemic on Pediatric Preventive Health Care Among North Carolina Children Enrolled in Medicaid

Journal of the Pediatric Infectious Diseases Society December 2023

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Thakkar PV, Scott Z, Hoffman M, Delarosa J, Hickerson J, Boutzoukas AE, Benjamin DK Jr., Brookhart MA, Zimmerman KO, Moorthy GS

This study used an administrative claims database from North Carolina Medicaid to evaluate the rates of well-child visits and immunization administration for children ≤14 months of age, and used a quasi-Poisson regression model to estimate the rate ratio of each outcome during the pandemic period (3/15/2020 through 3/15/2021) compared with the pre-pandemic period (3/15/2019 through 3/14/2020). The rates of well-child visits and immunization administrations among North Carolina children enrolled in public insurance substantially decreased during the first year of the COVID-19 pandemic.

Improving Outcomes for Infants After Cardiopulmonary Bypass Surgery for Congenital Heart Disease: A Commentary on Recent Randomized Controlled Trials

Pediatric Critical Care Medicine November 2023

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Schlapbach LJ, Gibbons KS, Butt W, Kannankeril PJ, Li JS, Hill KD, NITRIC Study Group, STRESS Network Investigators

The recent NITRIC and STRESS trials demonstrate opportunities to perform pragmatic large randomized trials in congenital heart disease. We discuss lessons learnt from these trials which can inform future trial design and conduct in the field of pediatric heart surgery.
Thumbnail screenshot of Clindamycin results-at-a-glance.

Clindamycin Results-at-a-Glance

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Clindamycin is an antibiotic medicine that is often given to children to treat infections like methicillin-resistant Staphylococcus aureus (MRSA). Despite its common use in children, there is little information on the pharmacokinetics, how the drug is processed, of clindamycin in pediatric groups. These studies were needed to learn the safest, most effective dosage of clindamycin in children ranging in age from premature infants to adolescents.

 

Thumbnail photo of metronidazole results-at-a-glance.

Metronidazole Results-at-a-Glance

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Metronidazole is an antibiotic that is often used when treating infants with complicated intra-abdominal infections. However, the medicine is not approved for use in infants by the U.S. Food and Drug Administration (FDA). This study was needed to learn more about the safest and most effective dosage of metronidazole for treating cIAIs in infants.

Assessing clinical site readiness for electronic health record (EHR)-to-electronic data capture (EDC) automated data collection

Contemporary Clinical Trials May 2023

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Eisenstein EL, Zozus MN, Garza MY, Lanham HJ, Adagarla B, Walden A, Zimmerman KO, Kumar KR

eSource software is used to automatically copy a patient’s electronic health record data into a clinical study’s electronic case report form. However, there is little evidence to assist sponsors in identifying the best sites for multi-center eSource studies. This site developed an eSource site readiness survey. The survey was administered to principal investigators, clinical research coordinators, and chief research information officers at Pediatric Trial Network sites.

Safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia: Rationale and methods of a phase II randomized trial

Contemporary Clinical Trials Communications December 2022

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Lang JE, Hornik CD, Martz K, Jacangelo J, Anand R, Greenberg R, Hornik C, Zimmerman K, Smith PB, Benjamin DK, Laughon M
Bronchopulmonary dysplasia (BPD) is a disease of chronic respiratory insufficiency stemming from premature birth and iatrogenic lung injury leading to many complications. BPD is the most common pulmonary sequela of prematurity and is often fatal; however, there remains no FDA-approved therapies to treat or prevent BPD. Sildenafil is increasingly used off-label in premature infants despite scant safety and efficacy data. We developed the phase II SIL02 trial to describe the safety, pharmacokinetics and preliminary effectiveness of intravenous and enteral sildenafil in premature infants at risk for BPD.