Research Topics
Species | P Brian SmithSummaryAffiliation: Duke University Medical Center Country: USA Publications
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Publications
Pharmacokinetics of an elevated dosage of micafungin in premature neonatesP Brian Smith
Department of Pediatrics and Duke Clinical Research Institute, Duke University, Durham, NC 27715, USA
Pediatr Infect Dis J 28:412-5. 2009..The primary objective of this study was to assess the safety and pharmacokinetics of an increased (15 mg/kg/d) dose of micafungin...
Approach to infants born at 22 to 24 weeks' gestation: relationship to outcomes of more-mature infantsP Brian Smith
Department of Pediatrics, Duke University, Durham, North Carolina 27715, USA
Pediatrics 129:e1508-16. 2012..We sought to determine if a center's approach to care of premature infants at the youngest gestational ages (22-24 weeks' gestation) is associated with clinical outcomes among infants of older gestational ages (25-27 weeks' gestation)...
Is an increased dwell time of a peripherally inserted catheter associated with an increased risk of bloodstream infection in infants?P Brian Smith
Department of Pediatrics, Duke University, Durham, North Carolina 27715, USA
Infect Control Hosp Epidemiol 29:749-53. 2008..To estimate the risk of bloodstream infection associated with catheter dwell time in infants...
Safety monitoring of drugs receiving pediatric marketing exclusivityP Brian Smith
MHS, Duke University Medical Center, Box 3179, Durham, NC 27710, USA
Pediatrics 122:e628-33. 2008..We sought to describe the Pediatric Advisory Committee's recommendations made in response to safety reviews informed by data from the Food and Drug Administration Adverse Event Reporting System in 67 drugs granted exclusivity...
Meningitis in preterm neonates: importance of cerebrospinal fluid parametersP Brian Smith
Department of Pediatrics, Duke University, Durham, North Carolina 27710, USA
Am J Perinatol 25:421-6. 2008..Cerebrospinal fluid parameters used to diagnose meningitis in the absence of dependable cerebrospinal fluid cultures are unreliable. Caution should be employed when interpreting cerebrospinal fluid parameters in the premature neonate...
Safety of placebo controls in pediatric hypertension trialsP Brian Smith
Food and Drug Administration, Rockville, MD, USA
Hypertension 51:829-33. 2008..Short-term exposure to placebo in pediatric trials of antihypertensive medications appears to be safe...
Cough in pediatric patients receiving angiotensin-converting enzyme inhibitor therapy or angiotensin receptor blocker therapy in randomized controlled trialsC M Baker-Smith
Department of Pediatrics, Duke University, Durham, North Carolina, USA
Clin Pharmacol Ther 87:668-71. 2010..The incidence of cough in children receiving ACEis (reported cough, 3.2%) was similar to that in children receiving ARBs (reported cough, 1.8%) (P = 0.34). Reports of cough were lower in children than in adults...
Group B streptococcal meningitis: cerebrospinal fluid parameters in the era of intrapartum antibiotic prophylaxisAnnette K Ansong
Department of Pediatrics, Duke University, Durham, North Carolina, USA
Early Hum Dev 85:S5-7. 2009..Describe cerebrospinal fluid parameters in infants with culture-proven Group B streptococcal meningitis in the era of intrapartum antibiotic prophylaxis...
Use of the complete blood cell count in late-onset neonatal sepsisChristoph P Hornik
Department of Pediatrics, Duke University, Durham, NC 27715, USA
Pediatr Infect Dis J 31:803-7. 2012..Diagnosis of late-onset sepsis can be challenging. The complete blood cell count and differential have been previously evaluated as diagnostic tools for late-onset sepsis in small, single-center reports...
Traumatic lumbar punctures in neonates: test performance of the cerebrospinal fluid white blood cell countRachel G Greenberg
Department of Pediatrics, Duke University, Durham, NC, USA
Pediatr Infect Dis J 27:1047-51. 2008..The purpose of this study is to evaluate the diagnostic utility of adjusting CSF white blood cell counts based on CSF and peripheral red blood cell counts...
Early and late onset sepsis in late preterm infantsMichael Cohen-Wolkowiez
Department of Pediatrics, Duke University, Durham, NC 27715, USA
Pediatr Infect Dis J 28:1052-6. 2009..Early and late onset sepsis results in significant mortality in extremely preterm infants, but little is known about sepsis outcomes in late preterm infants...
Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenationKevin M Watt
Duke University, Pediatrics, Duke Clinical Research Institute, P O Box 3499, Durham, NC 27710, USA
Pediatr Infect Dis J 31:1042-7. 2012..The ECMO circuit can alter drug pharmacokinetics; thus, standard fluconazole dosing in children on ECMO may result in suboptimal drug exposure. This study determined the pharmacokinetics of fluconazole in infants on ECMO...
Predictive value of cerebrospinal fluid parameters in neonates with intraventricular drainage devicesRobert W Lenfestey
Department of Pediatrics, Duke University, Durham, North Carolina, USA
J Neurosurg 107:209-12. 2007..The goal of this study was to determine the normal ranges for cell count parameters in neonates with VP shunts and CSF reservoirs, as well as to determine the predictive value of CSF parameters as markers of infection...
Very late onset infections in the neonatal intensive care unitJames L Wynn
Department of Pediatrics, Duke University, Durham, NC, USA
Early Hum Dev 88:217-25. 2012..We sought to determine the risk factors, incidence, and mortality of very late onset bacterial infection (blood, urine, or cerebrospinal fluid culture positive occurring after day of life 120) in preterm infants...
Neonatal meningitis: what is the correlation among cerebrospinal fluid cultures, blood cultures, and cerebrospinal fluid parameters?Harmony P Garges
Pediatrics, Duke University, Durham, North Carolina, USA
Pediatrics 117:1094-100. 2006..Abnormal cerebrospinal fluid (CSF) parameters are often used to predict neonatal meningitis and determine length and type of antibiotic therapy in neonates with a positive blood culture and negative CSF culture...
Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infectionsMichael Cohen-Wolkowiez
Department of Pediatrics, Duke University, Durham, North Carolina 27715, USA
Clin Infect Dis 55:1495-502. 2012..The purpose of this study was to determine the safety and effectiveness of meropenem in young infants with suspected or complicated intra-abdominal infections...
Use of the complete blood cell count in early-onset neonatal sepsisChristoph P Hornik
Department of Pediatrics, Duke University, Durham, NC 27715, USA
Pediatr Infect Dis J 31:799-802. 2012..We evaluated the diagnostic accuracy of the complete blood cell count and differential in EOS in a large, multicenter population of neonates admitted to the neonatal intensive care unit...
Empiric antifungal therapy and outcomes in extremely low birth weight infants with invasive candidiasisRachel G Greenberg
Department of Pediatrics, Duke University, Durham, NC, USA
J Pediatr 161:264-9.e2. 2012..To assess the impact of empiric antifungal therapy for invasive candidiasis on subsequent outcomes in premature infants...
Antifungal therapy and outcomes in infants with invasive Candida infectionsSimon B Ascher
Department of Pediatrics, Duke University Medical Center, Durham, NC, USA
Pediatr Infect Dis J 31:439-43. 2012..Invasive candidiasis is a leading cause of mortality and morbidity in neonatal intensive care units. Treatment recommendations are limited by a lack of comparative outcomes data...
Safety and transparency of pediatric drug trialsDaniel K Benjamin
Department of Pediatrics, Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA
Arch Pediatr Adolesc Med 163:1080-6. 2009....
Center variation in patient age and weight at Fontan operation and impact on postoperative outcomesMichelle C Wallace
Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina 27715, USA
Ann Thorac Surg 91:1445-52. 2011..We evaluated variation in age, weight, and weight-for-age z-score at Fontan across institutions, and the impact of these variables on postoperative morbidity and mortality...
Coagulase-negative staphylococcal infections in the neonatal intensive care unitNaomi Jean-Baptiste
Duke Clinical Research Institute, Durham, North Carolina 27715, USA
Infect Control Hosp Epidemiol 32:679-86. 2011..Coagulase-negative staphylococci (CoNS) are the most commonly isolated pathogens in the neonatal intensive care unit (NICU). CoNS infections are associated with increased morbidity, including neurodevelopmental impairment...
Pediatric antihypertensive trial failures: analysis of end points and dose rangeDaniel K Benjamin
Office of Pediatric Therapeutics, US Food and Drug Administration, Rockville, MD, USA
Hypertension 51:834-40. 2008..More importantly, our ability to combine data across trials allowed us to evaluate and potentially improve trial design...
Population pharmacokinetics of metronidazole evaluated using scavenged samples from preterm infantsMichael Cohen-Wolkowiez
Department of Pediatrics, Duke University, Durham, North Carolina, USA
Antimicrob Agents Chemother 56:1828-37. 2012..Minimal-risk methods such as scavenged PK sampling provided meaningful information related to development of metronidazole PK models and dosing recommendations...
Association between thrombosis and bloodstream infection in neonates with peripherally inserted cathetersCourtney D Thornburg
Department of Pediatrics, Duke University, Durham, NC, USA
Thromb Res 122:782-5. 2008..The primary objective of this study was to determine the association between catheter associated blood stream infection (CABSI) and catheter-related thrombosis in the Neonatal Intensive Care Unit...
Treatment of patent ductus arteriosus with bidirectional flow in neonatesPatrick N Ethington
Department of Pediatrics, Duke University, Durham, NC 27710, United States
Early Hum Dev 87:381-4. 2011..The clinical decision to treat the patent ductus arteriosus is complicated by the lack of evidence available regarding clinical conditions under which closure should be attempted...
Fluconazole loading dose pharmacokinetics and safety in infantsLauren Piper
Department of Pediatrics and Duke Clinical Research Institute, Duke University, Durham, NC, USA
Pediatr Infect Dis J 30:375-8. 2011..A loading dose of fluconazole is advised for older patients but has not been evaluated in infants. We sought to determine the pharmacokinetics and safety of a fluconazole loading dose in infants at risk for invasive fungal infection...
Mortality and neurodevelopmental outcome after Staphylococcus aureus bacteremia in infantsMichael Cohen Wolkowiez
Department of Pediatrics, Duke University, Durham, NC, USA
Pediatr Infect Dis J 26:1159-61. 2007..Infants with methicillin-resistant S. aureus infection had a longer median duration of bacteremia (4.5 versus 1 day, P = 0.01), but no difference in length of hospital stay, mortality, or neurodevelopmental impairment...
Protocolized approach to the management of congenital diaphragmatic hernia: benefits of reducing variability in careElisabeth T Tracy
Department of Surgery, Duke University Medical Center, Durham, NC 27710, USA
J Pediatr Surg 45:1343-8. 2010..Our institution developed a comprehensive evidence-based protocol to standardize the management of CDH infants. This report reviews patient outcomes before and after the implementation of the protocol...
Outcomes of catheter-associated infections in pediatric patients with short bowel syndromeRachel G Greenberg
Department of Pediatrics, Duke Clinical Research Institute, Duke University, Durham, NC, USA
J Pediatr Gastroenterol Nutr 50:460-2. 2010..We conducted a retrospective observational study in children with short bowel syndrome to compare outcomes of catheter-associated infections treated with catheter removal plus antibiotic therapy versus antibiotic therapy alone...
Outcomes following candiduria in extremely low birth weight infantsJames L Wynn
Department of Pediatrics, Duke University, Durham, NC 27715, USA
Clin Infect Dis 54:331-9. 2012..Candidiasis carries a significant risk of death or neurodevelopmental impairment (NDI) in extremely low birth weight infants (ELBW; <1000 g). We sought to determine the impact of candiduria in ELBW preterm infants...
Prediction of bronchopulmonary dysplasia by postnatal age in extremely premature infantsMatthew M Laughon
Department of Pediatrics, University of North Carolina, Chapel Hill, North Carolina 27599 7596, USA
Am J Respir Crit Care Med 183:1715-22. 2011....
Effect of methicillin-resistant Staphylococcus aureus colonization in the neonatal intensive care unit on total hospital costEric D Schultz
Department of Pediatrics, Duke University Medical Center, Durham, North Carolina, USA
Infect Control Hosp Epidemiol 30:383-5. 2009..We determined the economic impact of isolating and cohorting MRSA-colonized neonates on total hospital cost at a 49-bed, level III-IV neonatal intensive care unit...
Risk Factors for Invasive Candidiasis in Infants >1500 g Birth WeightJan Hau Lee
From the Department of Pediatrics, Duke University Medical Center Duke Clinical Research Institute, Duke University Medical Center, Durham, NC Department of Pediatric Subspecialties, KK Women s and Children s Hospital, Singapore Department of Biostatistics, University of North Carolina, Chapel Hill, NC and Pediatrix Medical Group, Sunrise, FL
Pediatr Infect Dis J 32:222-6. 2013..We describe the incidence, risk factors and outcomes of invasive candidiasis in infants >1500 g birth weight...
Pharmacokinetics and tolerability of single-dose daptomycin in young infantsMichael Cohen-Wolkowiez
Department of Pediatrics, Duke University Medical Center, and Duke Clinical Research Institute, Durham, NC 27715, USA
Pediatr Infect Dis J 31:935-7. 2012..Daptomycin is approved for the treatment of complicated skin and skin-structure infections and Staphylococcus aureus bacteremia. We sought to characterize daptomycin single-dose pharmacokinetics and tolerability in young infants...
Very low birth weight neonates who survive early-onset sepsis do not have an increased risk of developing late-onset sepsisCheryl B Lin
Duke University National University of Singapore, Singapore
Early Hum Dev 88:905-9. 2012..In critically ill children and adults, sepsis increases subsequent infection risk. It is unknown whether sepsis modifies the risk of subsequent infection in VLBWs...
Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid of infants with suspected or complicated intra-abdominal infectionsP Brian Smith
Department of Pediatrics, Duke University, Durham, NC, USA
Pediatr Infect Dis J 30:844-9. 2011..The purpose of this study was to determine the pharmacokinetics (PK) of meropenem in young infants as a basis for optimizing dosing and minimizing adverse events...
Cardiovascular abnormalities in late-onset Pompe disease and response to enzyme replacement therapyDaniel Forsha
Department of Pediatrics, Duke University Medical Center, Durham, NC 27715, USA
Genet Med 13:625-31. 2011..We evaluated the prevalence of cardiovascular abnormalities and the efficacy and safety of enzyme replacement therapy in patients with late-onset Pompe disease...
Population pharmacokinetics of fluconazole in young infantsK C Wade
Department of Pediatrics, Division of Neonatology, Children s Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, USA
Antimicrob Agents Chemother 52:4043-9. 2008..This population PK model of fluconazole discriminated the impact of BGA, PNA, and creatinine on drug CL. Our data suggest that dosing in young infants will require adjustment for BGA and PNA to achieve targeted systemic drug exposures...
The use of antifungal therapy in neonatal intensive careDaniela Testoni
Duke Clinical Research Institute, Duke University Medical Center, 2400 Pratt Street, Durham, NC 27705, USA
Clin Perinatol 39:83-98. 2012..We conclude that more studies are required for antifungals to be used safely and effectively in infants...
Cytokine gene polymorphisms and the outcome of invasive candidiasis: a prospective cohort studyMelissa D Johnson
Duke University Medical Center, Durham, North Carolina, USA
Clin Infect Dis 54:502-10. 2012..Although clinical and microbiological factors affecting prognosis have been identified, the impact of genetic variation in the innate immune responses mediated by cytokines on outcomes of infection remains to be studied...
Dynamic change of fecal calprotectin in very low birth weight infants during the first month of lifeQing Yang
Department of Pediatrics, Division of Neonatology, Duke University Medical Center, Durham, NC, USA
Neonatology 94:267-71. 2008..Calprotectin is a cytosolic component of neutrophils. Fecal calprotectin (FC) level is a useful marker for exacerbation of inflammatory bowel disease in children. FC may be a useful marker for necrotizing enterocolitis (NEC)...
Performance of the AST-to-platelet ratio index as a noninvasive marker of fibrosis in pediatric patients with chronic viral hepatitisKatherine E McGoogan
Department of Pediatrics, Duke University Medical Center, Durham, NC 27710, USA
J Pediatr Gastroenterol Nutr 50:344-6. 2010..Further research into APRI and the other noninvasive markers of fibrosis in children with chronic viral hepatitis is warranted...
Quantification of 1,3-beta-D-glucan levels in children: preliminary data for diagnostic use of the beta-glucan assay in a pediatric settingP Brian Smith
Department of Pediatrics, Division of Pediatric Infectious Diseases, Duke University Medical Center, Durham, North Carolina 27710, USA
Clin Vaccine Immunol 14:924-5. 2007..We found higher 1,3-beta-D-glucan levels in children than those previously reported in adults...
Globalization of pediatric research: analysis of clinical trials completed for pediatric exclusivitySara K Pasquali
Duke University Medical Center, Department of Pediatrics, Division of Cardiology, PO Box 17969, Durham, NC 27715, USA
Pediatrics 126:e687-92. 2010..We evaluated the setting of published studies conducted under the US Pediatric Exclusivity Provision, which provides economic incentives to pharmaceutical companies to conduct drug studies with children...
Anidulafungin: a new echinocandin for the treatment of fungal infectionsMichael Cohen-Wolkowiez
Department of Pediatrics, Miami Children's Hospital, Florida, USA
Drugs Today (Barc) 42:533-44. 2006..In February 2006, the U.S. Food and Drug Administration approved the echinocandin anidulafungin for the treatment of patients with candidemia, peritonitis, intra-abdominal abscesses and esophageal candidiasis...
The (1,3){beta}-D-glucan test as an aid to early diagnosis of invasive fungal infections following lung transplantationBarbara D Alexander
Division of Infectious Diseases and International Health, Department of Medicine, Clinical Microbiology Laboratory, Duke University Medical Center, Durham, North Carolina 27710, USA
J Clin Microbiol 48:4083-8. 2010..Although the NPV of the BG test is high, the low PPV limits its utility as a screening tool for early diagnosis of IFI...
Isoflurane for life-threatening bronchospasm: a 15-year single-center experienceDavid A Turner
Division of Pediatric Critical Care Medicine, Department of Pediatrics, Duke Children s Hospital, Duke University Medical Center, Durham, NC 27710, USA
Respir Care 57:1857-64. 2012..We hypothesized that isoflurane is safe and would lead to improved gas exchange in children with life-threatening bronchospasm refractory to conventional therapy...
Antibiotic use and misuse in the neonatal intensive care unitNidhi Tripathi
Duke University Medical Center, Durham, NC 27710, USA
Clin Perinatol 39:61-8. 2012....
Bias flow does not affect ventilation during high-frequency oscillatory ventilation in a pediatric animal model of acute lung injuryDavid A Turner
Division of Pediatric Critical Care Medicine, Department of Pediatrics, Duke Children s Hospital, Duke University Medical Center, Durham, NC, USA
Pediatr Crit Care Med 13:e108-12. 2012..We hypothesize that in a swine model of acute lung injury, increased bias flow rates will not affect CO(2) elimination...
Neonatal candidiasisP Brian Smith
Department of Pediatrics, Duke University Medical Center, Durham, NC 27710, USA
Infect Dis Clin North Am 19:603-15. 2005..Although some pharmacokinetic data for some products are available for term and near-term infants, optimal product choice, closing, and other treatment strategies also are unknown in this older age group...
Safety and effectiveness of indomethacin versus ibuprofen for treatment of patent ductus arteriosusLakshmi I Katakam
Department of Pediatrics, Duke University Medical Center, Durham, North Carolina, USA
Am J Perinatol 27:425-9. 2010..The decision to use one agent over the other should be based on dose schedule preference and the currently published clinical trials until more safety and effectiveness data are available...
Risk factors and prevention of late-onset sepsis in premature infantsL Corbin Downey
Department of Pediatrics, Children s Hospital of the King s Daughters, Norfolk, VA, USA
Early Hum Dev 86:7-12. 2010..In this review, we will outline the risk factors for development of late-onset sepsis and evidence supporting methods for prevention of late-onset sepsis in premature infants...
Prevalence of iron deficiency in children with Down syndromeNatalia E Dixon
Department of Pediatrics, Hematology Oncology, Duke University Medical Center, Durham, NC, USA
J Pediatr 157:967-971.e1. 2010..To determine the prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) in a sample of children with Down syndrome (DS) and to evaluate the effect of macrocytosis on the diagnosis of ID/IDA in these children...
Excess costs of hospital care associated with neonatal candidemiaP Brian Smith
Department of Pediatrics, 3179 Duke University Medical Center, Durham NC, 27710, USA
Pediatr Infect Dis J 26:197-200. 2007..Candida is an increasingly important nosocomial pathogen within intensive care nurseries. The purpose of this study was to determine the attributable cost of candidemia in neonates...
Preliminary observations of the use of high-frequency jet ventilation as rescue therapy in infants with congenital diaphragmatic herniaMichael A Kuluz
Department of Pediatrics, Duke University, Durham, NC, USA
J Pediatr Surg 45:698-702. 2010..Several investigators have reported outcomes from centers using high-frequency oscillatory ventilation in their management of CDH, but there are no recent reports on use of high-frequency jet ventilation...
Duration of empirical antibiotic therapy for infants suspected of early-onset sepsisC Michael Cotten
Division of Neonatology, Department of Pediatrics, Duke University, Durham, North Carolina 27710, USA
Curr Opin Pediatr 25:167-71. 2013..Our purpose is to review current opinions and evidence influencing clinicians' choices for duration of empirically initiated antibiotics in newborns with sterile cultures...
Regional variation in late preterm births in North CarolinaSofia R Aliaga
Department of Pediatrics, University of North Carolina, 101 Manning Drive, Chapel Hill, NC 27599, USA
Matern Child Health J 17:33-41. 2013..We speculate that provider practice variation might explain some of the remaining difference. This is an area where policy changes and quality improvement efforts can help reduce variation, and potentially decrease LPT births...
Targeted interventions improve shared agreement of daily goals in the pediatric intensive care unitKyle J Rehder
Division of Pediatric Critical Care Medicine, Duke University Medical Center, Durham, NC, USA
Pediatr Crit Care Med 13:6-10. 2012..To improve communication during daily rounds using sequential interventions...
Vasopressin for refractory hypotension in extremely low birth weight infantsMargarita Bidegain
Division of Neonatal Perinatal Medicine, Jean and George Brumley, Jr, Neonatal Perinatal Research Institute, Department of Pediatrics, Duke University Medical Center, Durham, NC 27710, USA
J Pediatr 157:502-4. 2010..002) and allowed weaning of catecholamines in a group of extremely low birth weight infants with refractory hypotension...
