Journal of Pediatric Pharmacology and Therapeutics最新文献

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Subclinical Changes in Cardiovascular Function During the Neonatal Period in Infants Born to Mothers With Diabetes. 糖尿病母亲所生婴儿新生儿期心血管功能的亚临床变化
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5683/JPPT-25-00163
Colman I Freel, Ibrahim Alhaji Mohammed, Alice Lynch, Gauri Murali, Uma Subrayan, Shivi Tripathi, Fiona Xu, Daniel K Benjamin, Rachel G Greenberg, Melissa M Campbell, Rebekah A Rapoza, Corrine K Hanson, Paras Kumar Mishra, Daniel K Benjamin, Ann L Anderson-Berry
{"title":"Subclinical Changes in Cardiovascular Function During the Neonatal Period in Infants Born to Mothers With Diabetes.","authors":"Colman I Freel, Ibrahim Alhaji Mohammed, Alice Lynch, Gauri Murali, Uma Subrayan, Shivi Tripathi, Fiona Xu, Daniel K Benjamin, Rachel G Greenberg, Melissa M Campbell, Rebekah A Rapoza, Corrine K Hanson, Paras Kumar Mishra, Daniel K Benjamin, Ann L Anderson-Berry","doi":"10.5683/JPPT-25-00163","DOIUrl":"10.5683/JPPT-25-00163","url":null,"abstract":"<p><strong>Objective: </strong>The link between maternal diabetes and congenital heart defects is well-established; however, few studies have investigated subclinical cardiovascular dysfunction at birth, which may serve as an early indicator of future risk.</p><p><strong>Methods: </strong>We analyzed cardiovascular metrics, including heart rate and blood pressure during the postnatal hospital stay, in 1927 maternal-infant dyads at Nebraska Medicine (2012-2023), including 226 with gestational diabetes mellitus (GDM), 27 with type 1 DM (T1DM), 67 with type 2 DM (T2DM), and 1607 with no DM. Relationships between maternal diabetes subtype and neonatal cardiovascular metrics were examined using treatment effects modeling. Correlations between maternal glycemic burden, as assessed by average HbA1c and 1-hour oral glucose tolerance test (OGTT) during pregnancy, and newborn cardiovascular metrics were also evaluated.</p><p><strong>Results: </strong>Compared with no DM, T1DM was associated with higher newborn systolic blood pressure (SBP) (+4.6 mm Hg, p = 0.002), pulse pressure (PP) (+3.1 mm Hg, p = 0.006), and SBP variability (+1.2 mm Hg, p = 0.048). T2DM was associated with higher newborn SBP (+2.9 mm Hg, p = 0.03) and PP (+2.0 mm Hg, p = 0.02) and lower SBP variability (-1.3 mm Hg, p = 0.049). There were sigsnificant positive correlations between maternal HbA1c and newborn heart rate (p = 0.009, <i>R</i> <sup>2</sup> = 0.27), mean arterial pressure (p = 0.004, <i>R</i> <sup>2</sup> = 0.20), SBP (p < 0.001, <i>R</i> <sup>2</sup> = 0.22), diastolic BP (p = 0.03, <i>R</i> <sup>2</sup> = 0.17), and PP (p = 0.001, <i>R</i> <sup>2</sup> = 0.17). No correlations were observed between maternal 1-hour OGTT and newborn cardiovascular metrics.</p><p><strong>Conclusions: </strong>These findings indicate early subclinical changes in cardiovascular physiology in offspring of women with DM. The differential impacts of diabetes subtypes on newborn BP and strong link to maternal glycemic burden suggest severity and timing of maternal diabetes influence neonatal cardiovascular physiology.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"138-149"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12888998/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167100","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Vasopressor Strategy in Pediatric Sepsis: A Clinical Pharmacology Perspective. 儿童败血症的血管加压策略:临床药理学观点。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-25-00090
Danielle J Green, Kevin M Watt
{"title":"Vasopressor Strategy in Pediatric Sepsis: A Clinical Pharmacology Perspective.","authors":"Danielle J Green, Kevin M Watt","doi":"10.5863/JPPT-25-00090","DOIUrl":"10.5863/JPPT-25-00090","url":null,"abstract":"","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"112-114"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12889004/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146166923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Duke STAR Program and the Pediatric Trials Network. 杜克STAR项目和儿科试验网络。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-25-00143
Daniel K Benjamin, Sarah C Armstrong, Rachel G Greenberg
{"title":"Duke STAR Program and the Pediatric Trials Network.","authors":"Daniel K Benjamin, Sarah C Armstrong, Rachel G Greenberg","doi":"10.5863/JPPT-25-00143","DOIUrl":"https://doi.org/10.5863/JPPT-25-00143","url":null,"abstract":"","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"118-119"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12889010/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Rising Role of Artificial Intelligence in Clinical Pharmacometrics and Model-Informed Precision Dosing in Pediatrics. 人工智能在儿科临床药物计量学和模型信息精确给药中的作用日益增强。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-25-01207
Tomoyuki Mizuno, Michael N Neely
{"title":"Rising Role of Artificial Intelligence in Clinical Pharmacometrics and Model-Informed Precision Dosing in Pediatrics.","authors":"Tomoyuki Mizuno, Michael N Neely","doi":"10.5863/JPPT-25-01207","DOIUrl":"10.5863/JPPT-25-01207","url":null,"abstract":"","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"106-111"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12888991/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167151","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effectiveness of Ibuprofen Arginine, Ibuprofen Lysine, and Indomethacin for Patent Ductus Arteriosus Closure in Neonates. 布洛芬精氨酸、布洛芬赖氨酸和吲哚美辛治疗新生儿动脉导管未闭的疗效。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-24-00104
Meghna Basnet, Densley Perez, Eileen Chung, Caitlin Murtagh
{"title":"Effectiveness of Ibuprofen Arginine, Ibuprofen Lysine, and Indomethacin for Patent Ductus Arteriosus Closure in Neonates.","authors":"Meghna Basnet, Densley Perez, Eileen Chung, Caitlin Murtagh","doi":"10.5863/JPPT-24-00104","DOIUrl":"10.5863/JPPT-24-00104","url":null,"abstract":"<p><strong>Objective: </strong>Given the limited data on the use of ibuprofen arginine for the closure of patent ductus arteriosus (PDA), this study aims to retrospectively assess PDA closure rates and the safety profile of ibuprofen arginine as compared with ibuprofen lysine and indomethacin in neonates across a multicenter hospital system.</p><p><strong>Methods: </strong>This retrospective cohort study included neonates with symptomatic PDA admitted between July 2021 and August 2023, who received at least 1 dose of injectable indomethacin, ibuprofen lysine, or ibuprofen arginine. The primary aim was to compare closure rates of the PDA during the initial course of pharmacologic therapy. Secondary outcomes included the failure of therapy necessitating a repeat course or surgical ligation and adverse effects such as gastrointestinal bleeding, acute kidney injury, necrotizing enterocolitis, chronic lung disease, and intraventricular hemorrhage.</p><p><strong>Results: </strong>A total of 54 patients were included in the analysis; 26 received indomethacin, 13 received ibuprofen lysine, and 15 received ibuprofen arginine. There was no significant difference among groups in terms of closure rates after 1 course (53% indomethacin, 39% ibuprofen lysine, and 47% ibuprofen arginine; p = 0.66). Similarly, no differences were found in the need for a repeat course (35% indomethacin, 54% ibuprofen lysine, and 53% ibuprofen arginine; p = 0.29) or surgical ligation. Adverse effects rates were comparable across the groups.</p><p><strong>Conclusions: </strong>Indomethacin, ibuprofen lysine and ibuprofen arginine can all be considered viable options for pharmacologic closure of PDA in this population. Future prospective studies are needed to confirm these results and optimize patient outcomes.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"37-42"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12888986/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparison of Low and High Dose Clonidine for Infants Admitted to the Neonatal Intensive Care Unit. 低剂量和高剂量可乐定对新生儿重症监护病房婴儿的比较。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-24-00140
Jacob Kelner, Clare Riotte, Ursula Marquis, Jessica Askew, Michael Brimacombe, Shabnam Lainwala
{"title":"Comparison of Low and High Dose Clonidine for Infants Admitted to the Neonatal Intensive Care Unit.","authors":"Jacob Kelner, Clare Riotte, Ursula Marquis, Jessica Askew, Michael Brimacombe, Shabnam Lainwala","doi":"10.5863/JPPT-24-00140","DOIUrl":"10.5863/JPPT-24-00140","url":null,"abstract":"<p><strong>Objective: </strong>This study compares the efficacy of starting with low-dose vs high-dose enteral clonidine for the treatment of pain, agitation, and opioid withdrawal in high-risk infants admitted to the neonatal intensive care unit (NICU).</p><p><strong>Methods: </strong>This was a retrospective chart review study of infants admitted to a level IV NICU between September 2014 and December 2022 who were started on enteral clonidine before 50 weeks post-menstrual age (PMA) for pain, agitation, or opioid withdrawal. Data were collected over the first 30 days of clonidine treatment. Infants started on low-dose (LDC: <4 mcg/kg/day) and high-dose clonidine (HDC: ≥4 mcg/kg/day) were compared using SPSS V29.0 (IBM) for statistical analyses.</p><p><strong>Results: </strong>Ninety-five infants met the inclusion criteria; 41 received LDC, and 54 received HDC. There were no statistically significant differences in any demographic parameter between the groups before starting clonidine. There was no difference in reduction in Neonatal-Pain, Agitation, and Sedation Scale (N-PASS) scores during the 30-day treatment period, despite the LDC group having a lower maximum clonidine dose (4 vs 8 mcg/kg/day, p ≤ 0.01) than the HDC group.</p><p><strong>Conclusion: </strong>Our observational study suggests that starting with LDC may be as effective as HDC in treating pain, agitation, and opioid withdrawal in infants admitted to the NICU.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"56-61"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12889002/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Time to Administration, Outcome and Cost Comparison of 2 Different Strategies to Dispense Alteplase in Pediatric Intestinal Failure. 阿替普酶治疗小儿肠衰竭的两种不同策略的给药时间、结果和成本比较。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-25-00041
Tara Bergland, Jessica Lynton, Mary Beth Davis, Riad Rahhal
{"title":"Time to Administration, Outcome and Cost Comparison of 2 Different Strategies to Dispense Alteplase in Pediatric Intestinal Failure.","authors":"Tara Bergland, Jessica Lynton, Mary Beth Davis, Riad Rahhal","doi":"10.5863/JPPT-25-00041","DOIUrl":"10.5863/JPPT-25-00041","url":null,"abstract":"<p><strong>Objective: </strong>Central venous catheter (CVC) thrombosis is a serious complication in pediatric intestinal failure (IF) patients who require long-term parenteral nutrition. Alteplase is commonly used to restore patency in catheter-related thrombosis. Dispensing practices may vary and include constitution of 2-mg ready-to-use vials by nursing staff or thawing of batched frozen syringes from previously cryopreserved larger alteplase vials, which requires pharmacy involvement. Objectives included comparing time to administration, CVC patency restoration rates, and cost between dispensing methods.</p><p><strong>Methods: </strong>Single-center retrospective study evaluating patients with IF who presented with catheter-related thrombosis and received alteplase between 2011 and 2017. Patients were consecutively enrolled from the Pediatric Intestinal Rehabilitation program's institutional database. Data included IF-related care during outpatient visits, emergency department (ED) visits, and hospitalizations, including thrombosis events. CVCs were placed by either a pediatric surgeon or the vascular access team, depending on catheter type. Removal occurred if patients were weaned off parenteral nutrition, had an irreparable line break, or a nonsalvageable infection. We reported the efficacy of the intervention in restoring CVC patency using a weight-based alteplase dosing. Cost analysis included assessment of medication cost, pharmacy technician, pharmacist, and nursing time.</p><p><strong>Results: </strong>We recorded 83 alteplase administrations in 16 patients. Most (81.9%) were instilled in tunneled single-lumen silicon catheters. Alteplase installation was performed in the outpatient clinic (35%), inpatient (59%), and the ED (6%). Ready-to-use 2-mg vials were used in 31% of cases. Median time to administration was significantly shorter with ready-to-use 2-mg vials compared with thawed frozen syringes, at 15 and 71 minutes, respectively (p < 0.0001). The success of restoring patency was noted in 65% and 70% of cases after 1 and 2 doses of alteplase, respectively. Cost was similar between dispensing thawed frozen syringes and ready-to-use 2-mg vials, at $189.0 and $190.4, respectively (based on 2023 expense data).</p><p><strong>Conclusions: </strong>In this population with long-term CVC dependence, dispensing alteplase using ready-to-use 2-mg vials was associated with a significantly shorter time to administration and comparable cost compared with batching and dispensing thawed frozen syringes.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"70-76"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12889006/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146166488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Duration of Antibiotic Therapy for Escherichia coli Bacteremia in Infants Without Cerebrospinal Fluid Evaluation. 无脑脊液婴儿大肠杆菌血症的抗生素治疗时间评价。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-25-00156
Ashley Stark, Jeffrey Faulkner, Anjalee Hou, Ryan Benjamin, Veeral N Tolia, Melissa Campbell, Kanecia O Zimmerman, Daniel K Benjamin, Daniel K Benjamin, Rachel G Greenberg, Angelique E Boutzoukas
{"title":"Duration of Antibiotic Therapy for <i>Escherichia coli</i> Bacteremia in Infants Without Cerebrospinal Fluid Evaluation.","authors":"Ashley Stark, Jeffrey Faulkner, Anjalee Hou, Ryan Benjamin, Veeral N Tolia, Melissa Campbell, Kanecia O Zimmerman, Daniel K Benjamin, Daniel K Benjamin, Rachel G Greenberg, Angelique E Boutzoukas","doi":"10.5863/JPPT-25-00156","DOIUrl":"10.5863/JPPT-25-00156","url":null,"abstract":"<p><strong>Objective: </strong><i>Escherichia coli</i> is a leading cause of Gram-negative rod bacteremia in infants. Cerebrospinal fluid (CSF) evaluation is often deferred, and guidance on antibiotic duration is lacking in these circumstances. We evaluated whether treatment duration is associated with infection recurrence or mortality.</p><p><strong>Methods: </strong>This cohort study included infants discharged from Pediatrix Medical Group neonatal intensive care units (NICUs) from 1997 to 2022 with first instance of <i>E coli</i> bacteremia. Infants with CSF evaluation, delayed antimicrobial initiation (>2 days), or death/discharge during therapy were excluded. Antibiotic duration was categorized as <14, 14-21, or >21 days. Associations between treatment duration and 30-day and in-hospital mortality and the combined outcome of recurrence of infection or death within 30 days were evaluated by using 2-way tabulations and inverse probability weighted regression adjustment (IPWRA) models. Sensitivity analysis excluded courses <5 days.</p><p><strong>Results: </strong>We included 1125 infants with <i>E coli</i> bacteremia. After adjusting for gestational age, postnatal age, number of positive cultures, and severe disease, shorter courses were associated with higher 30-day and in-hospital mortality and the combined outcome. IPWRA modeling confirmed lower risks among infants treated for longer durations. The results were similar in the sensitivity analysis.</p><p><strong>Conclusions: </strong>While the optimal duration of therapy for infants with <i>E coli</i> bacteremia without CSF evaluation requires further evaluation, our data suggest that infants should receive antibiotic therapy for at least 14 days and that longer durations (21 days) can be considered.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"123-130"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12888992/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
External Evaluation of a Plasma and Cerebrospinal Fluid Population Pharmacokinetics Model of Meropenem in Infants. 婴儿美罗培南血浆和脑脊液人群药代动力学模型的外部评价。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-25-00142
Angelique E Boutzoukas, Ngoc Betty Ngo, Stephen Balevic, Chi D Hornik, Matitiahu Berkovitch, Laura P James, Elkana Kohn, Sarah G Anderson, Sitora Turdalieva, Elizabeth H Payne, William Hope, Irja Lutsar, Daniel K Benjamin, Rachel G Greenberg
{"title":"External Evaluation of a Plasma and Cerebrospinal Fluid Population Pharmacokinetics Model of Meropenem in Infants.","authors":"Angelique E Boutzoukas, Ngoc Betty Ngo, Stephen Balevic, Chi D Hornik, Matitiahu Berkovitch, Laura P James, Elkana Kohn, Sarah G Anderson, Sitora Turdalieva, Elizabeth H Payne, William Hope, Irja Lutsar, Daniel K Benjamin, Rachel G Greenberg","doi":"10.5863/JPPT-25-00142","DOIUrl":"10.5863/JPPT-25-00142","url":null,"abstract":"<p><strong>Objective: </strong>Meropenem is commonly used to treat bloodstream and central nervous system (CNS) infections in preterm and term infants; however, the optimal dosage of meropenem in infants <3 months is not known, and its cerebrospinal fluid (CSF) pharmacokinetics (PK) are not well established in this age group.</p><p><strong>Methods: </strong>We externally evaluated a previously developed meropenem population PK model using opportunistic plasma and CSF PK samples collected in infants and children <2 years of age who received intravenous meropenem per standard of care. We evaluated model performance, and simulated age-dependent dosing regimens (20 and 40 mg/kg every 8 hours [12 hours if gestational age <32 weeks and postnatal age <2 weeks]) to estimate the reduction in CSF bacterial burden.</p><p><strong>Results: </strong>Clinical and PK data from 10 children were used to externally evaluate the NeoMero model; model predictive performance was satisfactory with the addition of NeoMero (n = 167) data. Visual predictive check of combined data showed reasonable concordance between predictions and observed concentrations for plasma and CSF. Dosing simulations adjusted for population minimum inhibitory concentration distributions for <i>Pseudomonas aeruginosa</i> estimated that a 20 mg/kg intravenous bolus dose reduced CSF bacterial burden by a weighted mean 5.13 (SD 1.51) log colony forming unit (CFU), while a 40 mg/kg intravenous bolus dose resulted in a weighted mean 5.48 (SD 1.14) log CFU reduction in CSF.</p><p><strong>Conclusions: </strong>The original NeoMero model performed reasonably well, and the proposed dosing regimens, that is, 20 or 40 mg/kg every 8 hours (12 hours if gestational age <32 weeks and postnatal age <2 weeks), depending on target MIC are estimated to achieve substantial bacterial killing in the CNS.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"150-160"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12889011/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Case Series: Use of Dalbavancin for Invasive Gram-Positive Infection in Children. 病例系列:使用达尔巴万辛治疗儿童侵袭性革兰氏阳性感染。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-24-00116
Arthur J Chang, Mary Kathryn Mannix, Patrick O Kenney, Katherine N Vermilye, Gitanjali L A Rebello, Jennifer Zwiener, Andrea Green Hines, Alice Sato, Shamim M Islam, Oscar G Gómez-Duarte, Karl O A Yu
{"title":"Case Series: Use of Dalbavancin for Invasive Gram-Positive Infection in Children.","authors":"Arthur J Chang, Mary Kathryn Mannix, Patrick O Kenney, Katherine N Vermilye, Gitanjali L A Rebello, Jennifer Zwiener, Andrea Green Hines, Alice Sato, Shamim M Islam, Oscar G Gómez-Duarte, Karl O A Yu","doi":"10.5863/JPPT-24-00116","DOIUrl":"10.5863/JPPT-24-00116","url":null,"abstract":"<p><strong>Objective: </strong>Dalbavancin, a lipoglycopeptide antibiotic active against Gram-positive bacteria with a prolonged in vivo half-life, was recently approved by the Food and Drug Administration for use in pediatric skin/soft tissue infection. Although use in adult skin/soft tissue infection and off-label use in adult osteoarticular and bloodstream infection are well documented, pediatric data are limited to pharmacokinetic data, 1 clinical trial, and case reports/series. Here, we describe the clinical and microbiologic details of cases in which dalbavancin was used at 2 pediatric hospitals.</p><p><strong>Methods: </strong>Chart review of all patients receiving dalbavancin for any indication in 2 pediatric hospitals between August 2020 and July 2025.</p><p><strong>Results: </strong>Dalbavancin was used in 20 patients (age range 2 weeks to 18 years) in the time period. Fifteen cases had infection with either methicillin-susceptible or -resistant <i>Staphylococcus aureus</i>, 16 had bacteremia, 2 had endocarditis, and 11 cases had isolates available for dalbavancin susceptibility testing; all proved susceptible. Reasons for dalbavancin use included need for intravenous therapy with relative contraindications for alternative oral antibiotics or outpatient parenteral antibiotic therapy, difficulty of intravenous access, and medication nonadherence. Most cases had an uncomplicated recovery. None had microbiologic failure.</p><p><strong>Conclusions: </strong>With the limitations of this series and prior published data, dalbavancin may be a safe and efficacious antibiotic for use in certain invasive Gram-positive infections in children. It is a reasonable alternative when faced with relative contraindications to inpatient or outpatient parenteral therapy, especially when bactericidal therapy is needed or preferred. Formal pediatric trials against the standard of care, especially beyond skin/soft tissue infection, are encouraged.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"88-101"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12889012/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167114","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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