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Pediatric Drug Development

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https://www.readbyqxmd.com/read/28319548/tanshinone-iia-attenuates-sevoflurane-neurotoxicity-in-neonatal-mice
#1
Yimeng Xia, Heng Xu, Chenfei Jia, Xiaodong Hu, Yu Kang, Xiaoxuan Yang, Qingsheng Xue, Guorong Tao, Buwei Yu
BACKGROUND: Sevoflurane is the most widely used inhalational anesthetic in pediatric medicine. Despite this, sevoflurane has been reported to exert potentially neurotoxic effects on the developing brain. Clinical interventions and treatments for these effects are limited. Tanshinone IIA (Tan IIA), extracted from Salvia miltiorrhiza (Danshen), has been documented to alleviate cognitive decline in traditional applications. Therefore, we hypothesized that preadministration of Tan IIA may attenuate sevoflurane-induced neurotoxicity, suggesting that Tan IIA is a new and promising drug capable of counteracting the effects of cognitive dysfunction produced by general anesthetics...
April 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28316941/acute-kidney-injury-following-spinal-instrumentation-surgery-in-children
#2
Jasper J Jöbsis, Abdullah Alabbas, Ruth Milner, Christopher Reilly, Kishore Mulpuri, Cherry Mammen
AIM: To determine acute kidney in jury (AKI) incidence and potential risk factors of AKI in children undergoing spinal instrumentation surgery. METHODS: AKI incidence in children undergoing spinal instrumentation surgery at British Columbia Children's Hospital between January 2006 and December 2008 was determined by the Acute Kidney Injury Networ classification using serum creatinine and urine output criteria. During this specific time period, all patients following spinal surgery were monitored in the pediatric intensive care unit and had an indwelling Foley catheter permitting hourly urine output recording...
March 6, 2017: World Journal of Nephrology
https://www.readbyqxmd.com/read/28306345/a-retrospective-study-on-non-drug-related-poisoning-in-the-community-among-children-from-south-india
#3
Debasis Das Adhikari, Saibal Das, Blessed Winston A, Kaysina Vazhudhi, Aniket Kumar, Margaret Shanthi Fx, Indira Agarwal
OBJECTIVES: This retrospective study was performed to determine the incidence, demographic distribution, types and outcomes across various non-drug related poisonings among children attending a tertiary care center in south India. METHODS: All children from 0-16 years who presented to the Paediatric Emergency Department, Christian Medical College, Vellore with non-drug related poisoning from October 2004 to September 2013 were included. RESULTS: Out of the total 997 cases of poisoning, 629 (63...
March 17, 2017: Hospital Practice (Minneapolis)
https://www.readbyqxmd.com/read/28299720/ketamine-infusion-as-a-counter-measure-for-opioid-tolerance-in-mechanically-ventilated-children-a-pilot-study
#4
Felix Neunhoeffer, Anja Hanser, Martin Esslinger, Vanja Icheva, Matthias Kumpf, Ines Gerbig, Michael Hofbeck, Jörg Michel
BACKGROUND: Drug rotation to prevent opioid tolerance is well recognized in chronic pain management. However, ketamine infusion as a counter measure for opioid tolerance is rarely described in mechanically ventilated children developing tolerance from prolonged opioid infusion. PATIENTS AND METHODS: We performed a retrospective study in a 14-bed medical-surgical-cardiac pediatric intensive care unit. Thirty-two mechanically ventilated children who had developed tolerance from prolonged intravenous infusion of opioids received a continuous intravenous infusion of ketamine as an opioid substitute for more than 2 days, scheduled in a drug rotation protocol...
March 15, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28295234/adverse-drug-reactions-in-children-the-double-edged-sword-of-therapeutics
#5
Abdelbaset A Elzagallaai, Michael J E Greff, Michael J Rieder
Adverse drug reactions (ADRs) represent a major health problem worldwide with high morbidity and mortality rates. ADRs are classified into type A (augmented) and type B (bizarre) ADRs with the former group being more common and the later less common but often severe and clinically more problematic due to their unpredictable nature and occurrence at any dose. Pediatric populations are especially vulnerable to ADRs due to the lack of data for this age group from the drug development process and because of the wide use of Off-label and unlicensed use of drugs...
March 13, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28290120/development-of-a-pediatric-physiologically-based-pharmacokinetic-model-of-clindamycin-using-opportunistic-pharmacokinetic-data
#6
Christoph P Hornik, Huali Wu, Andrea N Edginton, Kevin Watt, Michael Cohen-Wolkowiez, Daniel Gonzalez
Physiologically-based pharmacokinetic (PBPK) modeling is a powerful tool used to characterize maturational changes in drug disposition to inform dosing across childhood; however, its use is limited in pediatric drug development. Access to pediatric pharmacokinetic data is a barrier to widespread application of this model, which impedes its development and optimization. To support the development of a pediatric PBPK model, we sought to leverage opportunistically-collected plasma concentrations of the commonly used antibiotic clindamycin...
March 13, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28288357/epilepsy-prevalence-and-severity-predictors-in-mri-identified-focal-cortical-dysplasia
#7
Lauren M Maynard, James L Leach, Paul S Horn, Christine G Spaeth, Francesco T Mangano, Katherine D Holland, Lili Miles, Robert Faist, Hansel M Greiner
OBJECTIVES: To determine the prevalence of epilepsy and drug-resistant epilepsy in pediatric patients with focal cortical dysplasia (FCD) identified by magnetic resonance imaging (MRI). To determine clinical and imaging differences between those with drug-resistant epilepsy, drug-responsive epilepsy, and no epilepsy among children with MRI-identified FCD. METHODS: A keyword search of a hospital radiology database identified 97 study participants for inclusion in this retrospective study...
March 6, 2017: Epilepsy Research
https://www.readbyqxmd.com/read/28285235/knowledge-attitudes-and-practices-among-mothers-of-children-with-epilepsy-a-study-in-a-teaching-hospital
#8
Ali-Asghar Kolahi, Mohsen Abbasi-Kangevari, Pouya Bakhshaei, Farhad Mahvelati-Shamsabadi, Seyed-Hassan Tonekaboni, Ahmad-Reza Farsar
OBJECTIVE: Knowledge about epilepsy and attitudes towards patients with epilepsy can affect measures taken to manage epilepsy and seizures. Support and understanding of mothers is invaluable in enabling children with epilepsy to develop normal life skills in living with epilepsy. In order to identify the educational needs of mothers of children with epilepsy, their knowledge, attitudes, and practices should be assessed. Therefore, we interviewed a group of mothers of children with epilepsy who were referred to a pediatric neurology clinic in a teaching hospital...
March 9, 2017: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/28283175/efficacy-of-intravenous-sotalol-for-treatment-of-incessant-tachyarrhythmias-in-children
#9
Xiaomei Li, Yan Zhang, Haiju Liu, He Jiang, Haiyan Ge, Yi Zhang
Our objective was to evaluate the efficacy and safety of intravenous (IV) sotalol in the treatment of incessant tachyarrhythmias in children with normal cardiac function. Eighty-three children admitted to hospital from October 2011 to December 2014 were treated with IV sotalol or IV sotalol plus IV propafenone. The time to conversion to sinus rhythm and maintaining sinus rhythm were evaluated. Blood pressure, heart rate, QTc, PR intervals, and rhythm were monitored; 50 patients (60%) were converted to sinus rhythm with IV sotalol; time to conversion was 12...
February 10, 2017: American Journal of Cardiology
https://www.readbyqxmd.com/read/28279690/-early-clinical-trials-in-paediatric-oncology-in-spain-a-nationwide-perspective
#10
Francisco Bautista, Soledad Gallego, Adela Cañete, Jaume Mora, Cristina Díaz de Heredia, Ofelia Cruz, José María Fernández, Susana Rives, Pablo Berlanga, Raquel Hladun, Antonio Juan Ribelles, Luis Madero, Manuel Ramírez, Rafael Fernández Delgado, Antonio Pérez-Martínez, Cristina Mata, Anna Llort, Javier Martín Broto, María Elena Cela, Gema Ramírez, Constantino Sábado, Tomás Acha, Itziar Astigarraga, Ana Sastre, Ascensión Muñoz, Mercedes Guibelalde, Lucas Moreno
INTRODUCTION: Cancer is the leading cause of death between the first year of life and adolescence, and some types of diseases are still a major challenge in terms of cure. There is, therefore, a major need for new drugs. Recent findings in cancer biology open the door to the development of targeted therapies against individual molecular changes, as well as immunotherapy. Promising results in adult anti-cancer drug development have not yet been translated into paediatric clinical practice...
March 6, 2017: Anales de Pediatría: Publicación Oficial de la Asociación Española de Pediatría (A.E.P.)
https://www.readbyqxmd.com/read/28278563/development-assessment-of-hiv-exposed-children-aged-6-18-months-a-cohort-study-from-north-india
#11
Remya Rajan, Anju Seth, Sharmila B Mukherjee, Jagdish Chandra
HIV exposed children are vulnerable to developmental delay irrespective of their HIV status due to combined effect of risk factors like poverty, prenatal drug exposure, stress and chronic illness in family and malnutrition. This cohort study assessed the development of 50 HIV exposed children aged 6-18 months at a Pediatric Centre of Excellence in HIV care in India. The development was assessed using Development Assessment Scale for Indian Infants (DASII) at enrolment, 3 and 6 months later. The development quotient (DQ) scores and proportion of children with developmental delay (DQ ≤ 70) were compared among two sub-groups, HIV infected (HI) and HIV exposed uninfected (HEU) children...
March 5, 2017: AIDS Care
https://www.readbyqxmd.com/read/28277336/development-and-function-of-immune-cells-in-an-adolescent-patient-with-a-deficiency-in-the-interleukin-10-receptor
#12
Sharon Veenbergen, Marieke A van Leeuwen, Gertjan J J Driessen, Rogier Kersseboom, Lilian F de Ruiter, Rolien H C Raatgeep, Dicky J Lindenbergh-Kortleve, Ytje Simons-Oosterhuis, Katharina Biermann, Dicky J J Halley, Lissy de Ridder, Johanna C Escher, Janneke N Samsom
OBJECTIVE: Monogenic defects in the interleukin-10 (IL-10) pathway are extremely rare and cause infantile-onset inflammatory bowel disease (IBD)-like pathology. Understanding how immune responses are dysregulated in monogenic IBD-like diseases can provide valuable insight in "classical" IBD pathogenesis. Here, we studied long-term immune cell development and function in an adolescent IL-10 receptor (IL10RA)-deficient patient who presented in infancy with severe colitis and fistulizing perianal disease and is currently treated with immune suppressants...
March 8, 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28276480/selective-targeting-of-hdac1-2-elicits-anticancer-effects-through-gli1-acetylation-in-preclinical-models-of-shh-medulloblastoma
#13
Sonia Coni, Anna Barbara Mancuso, Laura Di Magno, Giulia Sdruscia, Simona Manni, Silvia Maria Serrao, Dante Rotili, Eleonora Spiombi, Francesca Bufalieri, Marialaura Petroni, Monika Kusio-Kobialka, Enrico De Smaele, Elisabetta Ferretti, Carlo Capalbo, Antonello Mai, Pawel Niewiadomski, Isabella Screpanti, Lucia Di Marcotullio, Gianluca Canettieri
SHH Medulloblastoma (SHH-MB) is a pediatric brain tumor characterized by an inappropriate activation of the developmental Hedgehog (Hh) signaling. SHH-MB patients treated with the FDA-approved vismodegib, an Hh inhibitor that targets the transmembrane activator Smoothened (Smo), have shown the rapid development of drug resistance and tumor relapse due to novel Smo mutations. Moreover, a subset of patients did not respond to vismodegib because mutations were localized downstream of Smo. Thus, targeting downstream Hh components is now considered a preferable approach...
March 9, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28271997/a-retrospective-study-of-clinical-profile-and-long-term-outcome-to-imatinib-mesylate-alone-in-childhood-chronic-myeloid-leukemia-in-chronic-phase
#14
(no author information available yet)
OBJECTIVE: Chronic myeloid leukemia (CML) is relatively rare malignancy in childhood. There are limited studies of use of Imatinib Mesylate (IM) alone in management of CML in this age group. METHOD: We retrospectively analyzed the outcome of 30 consecutive children with CML chronic phase treated with IM alone. RESULTS: The median age at the time of diagnosis was 11 years with male preponderance. Asthenia and abdominal discomfort due to splenomegaly were the most common presenting features and splenomegaly a dominant sign...
January 2017: Gulf Journal of Oncology
https://www.readbyqxmd.com/read/28270931/design-and-methods-of-the-pan-canadian-applying-biomarkers-to-minimize-long-term-effects-of-childhood-adolescent-cancer-treatment-able-nephrotoxicity-study-a-prospective-observational-cohort-study
#15
Kelly R McMahon, Shahrad Rod Rassekh, Kirk R Schultz, Maury Pinsk, Tom Blydt-Hansen, Cherry Mammen, Ross T Tsuyuki, Prasad Devarajan, Geoff D E Cuvelier, Lesley G Mitchell, Sylvain Baruchel, Ana Palijan, Bruce C Carleton, Colin J D Ross, Michael Zappitelli
BACKGROUND: Childhood cancer survivors experience adverse drug events leading to lifelong health issues. The Applying Biomarkers to Minimize Long-Term Effects of Childhood/Adolescent Cancer Treatment (ABLE) team was established to validate and apply biomarkers of cancer treatment effects, with a goal of identifying children at high risk of developing cancer treatment complications associated with thrombosis, graft-versus-host disease, hearing loss, and kidney damage. Cisplatin is a chemotherapy well known to cause acute and chronic nephrotoxicity...
2017: Canadian Journal of Kidney Health and Disease
https://www.readbyqxmd.com/read/28267083/toxic-epidermal-necrolysis-like-reaction-after-hematopoietic-stem-cell-transplantation-in-children
#16
Maura Faraci, Stefano Giardino, Edoardo Lanino, Giuseppe Morreale, Emilia Ghibaudo, Monica Francesia Berta, Marco Risso, Elio Castagnola, Mimmo Ripaldi, Andrea Moscatelli, Giovanni Ghigliotti
This study report clinical course, etiology, management, and long-term outcome of children who developed toxic epidermal necrolysis-like reaction (TEN-LR) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). We retrospectively collected children with TEN-LR occurring after allo-HSCT performed in 2 pediatric bone marrow units between 2005 and 2014. We identified 6 cases of TEN-LR of 322 patients (1.8%). Possible triggers of TEN included antibiotics, antiepileptics, antimycotics, and Mycoplasma infection...
March 6, 2017: Journal of Pediatric Hematology/oncology
https://www.readbyqxmd.com/read/28264021/antimicrobial-use-in-paediatric-patients-in-a-teaching-hospital-in-ethiopia
#17
Hafte Kahsay Kebede, Hailay Abrha Gesesew, Tewodros Eyob Woldehaimanot, Kabaye Kumela Goro
BACKGROUND: Antibiotics use in in children are different from adults due to a lack of data on pharmacokinetics, pharmacodynamics, efficacy and safety of drugs, different physiological spectrum, pediatrics populations being vulnerable to the majority of the illnesses, and the adverse effect of their irrational use is more serious. However, antibiotic use is not explored much in a paediatric population. The current study focused on antibiotic use among pediatric population using data from a tertiary hospital in Ethiopia...
2017: PloS One
https://www.readbyqxmd.com/read/28259508/-mydriatic-eye-drops-for-children-analysis-of-use
#18
R Dumont, E Bui Quoc, S Ajzenfisz, O Bourdon, S Prot-Labarthe
Mydriatic eye drops are indicated for ophthalmologic exams (fundus and cycloplegic effect for refraction diagnosis). Their use must be optimal to avoid adverse reactions. This is even more important in pediatrics, because few clinical studies were conducted in this population during drug development. We reviewed the use of mydriatic eye drops, gathering information from the Summary of Product Characteristics (SPC) from the Theriaque(®) database (CNHIM) and the manufacturers' information, in terms of dose, concentration and volume administered, age limit indications, recommendations for administration, and our local practice...
March 1, 2017: Archives de Pédiatrie: Organe Officiel de la Sociéte Française de Pédiatrie
https://www.readbyqxmd.com/read/28253282/identification-of-extensive-drug-resistant-pseudomonas-aeruginosa-strains-new-clone-st1725-and-high-risk-clone-st233
#19
Pamela Aguilar-Rodea, Gerardo Zúñiga, Benjamín Antonio Rodríguez-Espino, Alma Lidia Olivares Cervantes, Ana Estela Gamiño Arroyo, Sarbelio Moreno-Espinosa, Daniela de la Rosa Zamboni, Briceida López Martínez, María Del Carmen Castellanos-Cruz, Israel Parra-Ortega, Verónica Leticia Jiménez Rojas, Juan Carlos Vigueras Galindo, Norma Velázquez-Guadarrama
Several microorganisms produce nosocomial infections (NIs), among which Pseudomonas aeruginosa stands out as an opportunist pathogen with the capacity to develop multiresistance to first-choice antibiotics. From 2007 to 2013, forty-six NIs produced by P. aeruginosa were detected at a pediatric tertiary care hospital in Mexico with a significant mortality rate (17.39%). All isolates (n = 58/46 patients) were characterized by evaluating their response to several antibiotics as panresistant (PDR), extensively resistant (XDR), multiresistant (MDR) or sensitive (S)...
2017: PloS One
https://www.readbyqxmd.com/read/28248319/safety-dosing-and-pharmaceutical-quality-for-studies-that-evaluate-medicinal-products-including-biological-products-in-neonates
#20
Robert M Ward, Daniel Benjamin, Jeffrey S Barrett, Karel Allegaert, Ronald Portman, Jonathan M Davis, Mark A Turner
The study of medications among pediatric patients has increased worldwide since 1997 in response to new legislation and regulations, but these studies have not yet adequately addressed the therapeutic needs of neonates. Additionally, extant guidance developed by regulatory agencies worldwide does not fully address the specificities of neonatal drug development, especially among extremely premature newborns who currently survive. Consequently, an international consortium from Canada, Europe, Japan, and the United States was organized by the Critical Path Institute to address the content of guidance...
March 1, 2017: Pediatric Research
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