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Pediatric Drug Development

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https://www.readbyqxmd.com/read/28214777/utility-of-long-term-video-eeg-monitoring-for-children-with-staring
#1
Anup D Patel, Babitha Haridas, Zachary M Grinspan, Jack Stevens
OBJECTIVE: Staring spells are a common reason for referral to overnight epilepsy monitoring unit (EMU) evaluation. However, inpatient EMU admissions are expensive and time consuming. This study determined what percentage of those referred for staring had a confirmed epileptic seizure on long-term video-EEG monitoring (LTM) and developed a scoring system to help prioritize which patients should undergo this procedure. METHODS: We performed a four-year retrospective chart review of all children at a tertiary pediatric hospital who received LTM (long-term monitoring) for the purposes of characterizing staring...
February 16, 2017: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/28211134/effect-of-age-on-the-performance-of-bispectral-and-entropy-indices-during-sevoflurane-pediatric-anesthesia-a-pharmacometric-study
#2
Alberto Sciusco, Joseph F Standing, Yucheng Sheng, Pasquale Raimondo, Gilda Cinnella, Michele Dambrosio
BACKGROUND: Bispectral index (BIS) and entropy monitors have been proposed for use in children, but research has not supported their validity for infants. However, effective monitoring of young children may be even more important than for adults, to aid appropriate anesthetic dosing and reduce the chance of adverse consequences. This prospective study aimed to investigate the relationships between age and the predictive performance of BIS and entropy monitors in measuring the anesthetic drug effects within a pediatric surgery setting...
February 17, 2017: Paediatric Anaesthesia
https://www.readbyqxmd.com/read/28206886/guideline-for-monitoring-and-management-of-pediatric-patients-before-during-and-after-sedation-for-diagnostic-and-therapeutic-procedures-update-2016
#3
(no author information available yet)
The safe sedation of children for procedures requires a systematic approach that includes the following: no administration of sedating medication without the safety net of medical/dental supervision, careful presedation evaluation for underlying medical or surgical conditions that would place the child at increased risk from sedating medications, appropriate fasting for elective procedures and a balance between the depth of sedation and risk for those who are unable to fast because of the urgent nature of the procedure, a focused airway examination for large (kissing) tonsils or anatomic airway abnormalities that might increase thepotential for airway obstruction, a clear understanding of the medication's pharmacokinetic and pharmacodynamic effects and drug interactions, appropriate training and skills in airway management to allow rescue of the patient, age- and size-appropriate equipment for airway management and venous access, appropriate medications and reversal agents, sufficient numbers of staff to both carry out the procedure and monitor the patient, appropriate physiologic monitoring during and after the procedure, a properly equipped and staffed recovery area, recovery to the presedation level of consciousness before discharge from medical/dental supervision, and appropriate discharge instructions...
October 15, 2016: Pediatric Dentistry
https://www.readbyqxmd.com/read/28205374/developmental-pharmacokinetics-of-sirolimus-implications-for-precision-dosing-in-neonates-and-infants-with-complicated-vascular-anomalies
#4
Tomoyuki Mizuno, Tsuyoshi Fukuda, Chie Emoto, Paula S Mobberley-Schuman, Adrienne M Hammill, Denise M Adams, Alexander A Vinks
BACKGROUND: Sirolimus has recently been shown to be efficacious and tolerable in pediatric patients with complicated vascular anomalies. Nevertheless, dosing information remains very limited especially for neonates and infants. The purpose of this study was to develop an age-appropriate sirolimus starting dosing regimen based on the developmental changes in drug elimination capacity using data collected in neonates and infants. PROCEDURE: A recently developed sirolimus maturation model [Emoto et al...
February 16, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28205038/clinical-trial-simulations-and-pharmacometric-analysis-in-pediatrics-application-to-inhaled-loxapine-in-children-and-adolescents
#5
Min Dong, Tsuyoshi Fukuda, Sally Selim, Mark A Smith, Laura Rabinovich-Guilatt, James V Cassella, Alexander A Vinks
BACKGROUND AND OBJECTIVES: Loxapine for inhalation is a drug-device combination product approved in adults for the acute treatment of agitation associated with schizophrenia or bipolar I disorder. The primary objective of this study was to develop a clinical trial protocol to support a phase I pharmacokinetic study in children aged 10 years and older. In addition, this report details the results of the clinical study in relation to the predicted likelihood of achieving the target exposure associated with therapeutic effect in adults...
February 15, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28202762/maternal-binding-and-neutralizing-igg-responses-targeting-the-c-terminal-region-of-the-v3-loop-are-predictive-of-reduced-peripartum-hiv-1-transmission-risk
#6
David R Martinez, Nathan Vandergrift, Ayooluwa O Douglas, Erin McGuire, John Bainbridge, Nathan I Nicely, David C Montefiori, Georgia D Tomaras, Genevieve G Fouda, Sallie R Permar
The development of an effective maternal HIV-1 vaccine that could synergize with antiretroviral therapy (ART) to eliminate pediatric HIV-1 infection will require the characterization of maternal immune responses capable of blocking transmission of autologous HIV viruses to the infant. We previously identified that maternal plasma antibody binding to linear epitopes within the variable loop 3 (V3) region of HIV envelope (Env) and neutralizing responses against easy to neutralize tier 1 viruses were associated with reduced risk of peripartum HIV infection in the historic U...
February 15, 2017: Journal of Virology
https://www.readbyqxmd.com/read/28202262/cognitive-and-behavioral-effects-of-new-antiepileptic-drugs-in-pediatric-epilepsy
#7
REVIEW
Romina Moavero, Marta Elena Santarone, Cinzia Galasso, Paolo Curatolo
BACKGROUND: In pediatric epilepsy, neurodevelopmental comorbidities could be sometimes even more disabling than seizures themselves, therefore it is crucial for the clinicians to understand how to benefit these children, and to choose the proper antiepileptic drug for the treatment of epilepsy associated to a specific neurodevelopmental disorder. Aim of this paper is to discuss the potential impact on cognition and behavior of new and newest AEDs and to guide the choice of the clinicians for a targeted use in epilepsy associated with specific neurodevelopmental disorders...
February 12, 2017: Brain & Development
https://www.readbyqxmd.com/read/28199197/childhood-cancers-and-systems-medicine
#8
William L Stone, Kathryn J Klopfenstein, M J Hajianpour, Marcela I Popescu, Cathleen M Cook, Koymangalath Krishnan
Despite major advances in treatment, pediatric cancers in the 5-16 age group remain the most common cause of disease death, and one out of eight children with cancer will not survive. Among children that do survive, some 60% suffer from late effects such as cancer recurrence and increased risk of obesity. This paper will provide a broad overview of pediatric oncology in the context of systems medicine. Systems medicine utilizes an integrative approach that relies on patient information gained from omics technology...
March 1, 2017: Frontiers in Bioscience (Landmark Edition)
https://www.readbyqxmd.com/read/28199002/validating-the-shortened-quality-of-life-in-childhood-epilepsy-questionnaire-qolce-55-in-a-sample-of-children-with-drug-resistant-epilepsy
#9
Lauryn Conway, Elysa Widjaja, Mary Lou Smith, Kathy N Speechley, Mark A Ferro
OBJECTIVE: The aim of this study was to validate the newly developed shortened Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55) in a sample of children with drug-resistant epilepsy. METHODS: Data came from 136 children enrolled in the Impact of Pediatric Epilepsy Surgery on Health-Related Quality of Life Study (PEPSQOL), a multicenter prospective cohort study. Confirmatory factor analysis was used to assess the higher-order factor structure of the QOLCE-55...
February 15, 2017: Epilepsia
https://www.readbyqxmd.com/read/28192582/use-of-electronic-nicotine-delivery-systems-among-adolescents-status-of-the-evidence-and-public-health-recommendations
#10
Aarti D Kamat, Alison L Van Dyke
Although the prevalence of tobacco smoking has been declining in recent years, the use of electronic nicotine delivery systems (ENDS) such as of electronic cigarettes, vaporizers, and hookahs has been steadily rising, especially among adolescents. ENDS are not only advertised to children, but their sale via the Internet has made them easily accessible to youth. In general, children perceive ENDS as safe, or at least safer than smoking traditional combustible tobacco products; however, exposure to nicotine may have deleterious effects on the developing brain...
February 1, 2017: Pediatric Annals
https://www.readbyqxmd.com/read/28190698/therapeutic-effects-of-cannabinoids-in-animal-models-of-seizures-epilepsy-epileptogenesis-and-epilepsy-related-neuroprotection
#11
REVIEW
Evan C Rosenberg, Pabitra H Patra, Benjamin J Whalley
The isolation and identification of the discrete plant cannabinoids in marijuana revived interest in analyzing historical therapeutic claims made for cannabis in clinical case studies and anecdotes. In particular, sources as old as the 11th and 15th centuries claimed efficacy for crude marijuana extracts in the treatment of convulsive disorders, prompting a particularly active area of preclinical research into the therapeutic potential of plant cannabinoids in epilepsy. Since that time, a large body of literature has accumulated describing the effects of several of the >100 individual plant cannabinoids in preclinical models of seizures, epilepsy, epileptogenesis, and epilepsy-related neuroprotection...
February 9, 2017: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/28188045/treatment-issues-for-children-with-epilepsy-transitioning-to-adult-care
#12
REVIEW
Rima Nabbout, Carol S Camfield, Danielle M Andrade, Alexis Arzimanoglou, Catherine Chiron, Joyce A Cramer, Jacqueline A French, Eric Kossoff, Marco Mula, Peter R Camfield
This is the third of three papers that summarize the second symposium on Transition in Epilepsies held in Paris in June 2016. This paper focuses on treatment issues that arise during the course of childhood epilepsy and make the process of transition to adult care more complicated. Some AEDs used during childhood, such as stiripentol, vigabatrin, and cannabidiol, are unfamiliar to adult epilepsy specialists. In addition, new drugs are being developed for treatment of specific childhood onset epilepsy syndromes and have no indication yet for adults...
February 7, 2017: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/28186051/evaluation-of-electronic-prescribing-decision-support-system-at-a-tertiary-care-pediatric-hospital-the-user-acceptance-perspective
#13
Abdurahman Omar, Johan Ellenius, Synnöve Lindemalm
This study aims to evaluate pediatrician's acceptance, perception and use of Electronic Prescribing Decision Support Systems (EPDSS) at a tertiary care using Extended Technology Acceptance Model (TAM2). Qualitative research methodology was applied. Semi-structured questions were developed according to TAM2 model. Pediatricians perceived that the EPDSS is useful and they showed a favorable attitude. However, perceived ease of use and output quality appeared to affect use of EPDSS. Concerns were expressed about complicated screens, difficulty to read and view medication overview of the patient, the navigation requires many clicks and medication system don't meet their need...
2017: Studies in Health Technology and Informatics
https://www.readbyqxmd.com/read/28184367/novel-immunotherapies-for-autoimmune-hepatitis
#14
REVIEW
Shamir Cassim, Marc Bilodeau, Catherine Vincent, Pascal Lapierre
Autoimmune hepatitis (AIH) is a multifactorial autoimmune disease of unknown pathogenesis, characterized by a loss of immunological tolerance against liver autoantigens resulting in the progressive destruction of the hepatic parenchyma. Current treatments are based on non-specific immunosuppressive drugs. Although tremendous progress has been made using specific biological agents in other inflammatory diseases, progress has been slow to come for AIH patients. While current treatments are successful in the majority of patients, treatment discontinuation is difficult to achieve, and relapses are frequent...
2017: Frontiers in Pediatrics
https://www.readbyqxmd.com/read/28181715/development-of-age-based-weight-estimation-formulae-for-japanese-children
#15
Nobuyuki Nosaka, Takashi Yorifuji, Emily Knaup, Kohei Tsukahara, Takashi Muguruma, Ayumi Okada, Hirokazu Tsukahara, Hiroyuki Doi
BACKGROUND: Although dosing and sizing of resuscitation drugs and equipment are mostly weight based, time is usually insufficient to weigh critically ill children. Many age-based weight estimation formulae for emergency use have been developed worldwide; however, there is no specific formula for Japanese children. This study aimed to develop and validate age-based formulae for estimating body weight of children living in Japan. METHODS: We obtained 370,980 measurements of body weight from 39,547 participants aged 12-155 months...
February 9, 2017: Pediatrics International: Official Journal of the Japan Pediatric Society
https://www.readbyqxmd.com/read/28179212/association-between-n363s-and-bcli-polymorphisms-of-the-glucocorticoid-receptor-gene-nr3c1-and-glucocorticoid-side-effects-during-childhood-acute-lymphoblastic-leukemia-treatment
#16
Meriç Kaymak Cihan, Halil Gürhan Karabulut, Nüket Yürür Kutlay, Hatice Ilgın Ruhi, Ajlan Tükün, Lale Olcay
OBJECTIVE: Glucocorticoids (GCs) are the key drugs for the treatment of pediatric acute lymphoblastic leukemia (ALL). Herein, investigation of the relationship between the N363S and BclI polymorphisms of the GC receptor gene (NR3C1) and the side effects of GCs during pediatric ALL therapy was aimed. MATERIALS AND METHODS: N363S and BclI polymorphisms were analyzed in 49 patients with ALL treated between 2000 and 2012. Control group consisted 46 patients with benign disorders...
February 9, 2017: Turkish Journal of Haematology: Official Journal of Turkish Society of Haematology
https://www.readbyqxmd.com/read/28173649/-a-novel-mutation-in-kcnb1-gene-in-a-child-with-neuropsychiatric-comorbidities-with-both-intellectual-disability-and-epilepsy-and-review-of-literature
#17
P Miao, J Peng, C Chen, N Gai, F Yin
Objective: To explore the association between the phenotype and KCNB1 gene mutation. Method: Clinical information including physical features, laboratory and genetic data of one patient of mental retardation with refractory epilepsy from Department of Pediatrics, Xiangya Hospital in January 2016 was analyzed. This patient was discovered to have KCNB1 gene mutations through whole exome sequencing. Relevant information about KCNB1 gene mutation was searched and collected from Pubmed, CNKI, Human Gene Mutation Database(HGMD) and Online Mendelian Inheritance in Man(OMIM)...
February 2, 2017: Zhonghua Er Ke za Zhi. Chinese Journal of Pediatrics
https://www.readbyqxmd.com/read/28168828/relative-bioavailability-of-a-dolutegravir-dispersible-tablet-and-the-effects-of-low-and-high-mineral-content-water-on-the-tablet-in-healthy-adults
#18
Ann M Buchanan, Michael Holton, Ian Conn, Mark Davies, Mike Choukour, Brian R Wynne
Dolutegravir (DTG) is approved in the United States to treat HIV-1-infected patients weighing ≥30 kg. A dispersible DTG tablet formulation was recently developed for pediatric patients. This study compares the pharmacokinetics (PK) of the dispersible tablet with that of a previously evaluated granule formulation. In this randomized, open-label, crossover study, 15 healthy adults received single oral doses of DTG 20 mg every 7 days across 5 treatment arms: granules consumed immediately after mixture with purified water, dispersible DTG consumed immediately after reconstitution in low-mineral-content (LMC) or high-mineral-content (HMC) water, and dispersible DTG consumed 30 minutes after dispersal in LMC or HMC water...
February 7, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28167963/physicians-perspectives-on-the-diagnosis-and-treatment-of-chronic-nonbacterial-osteomyelitis
#19
Yongdong Zhao, Fatma Dedeoglu, Polly J Ferguson, Sivia K Lapidus, Ronald M Laxer, Miranda C Bradford, Suzanne C Li
Background/Purpose. Understanding the practices of pediatric rheumatologists in diagnosing and treating chronic nonbacterial osteomyelitis (CNO) can provide important information to guide the development of consensus treatment plans. The objectives of this study were to determine physicians' approaches to (1) diagnosing and monitoring CNO, (2) ordering a bone biopsy, and (3) making treatment decisions. Methods. A survey was distributed among members of the Childhood Arthritis and Rheumatology Research Alliance using a web-based questionnaire...
2017: International Journal of Rheumatology
https://www.readbyqxmd.com/read/28164036/primary-extrapulmonary-multidrug-resistant-tuberculosis-in-an-immunocompetent-child-presenting-with-pleural-effusion
#20
Sankalp Yadav, Gautam Rawal
The developing countries are having a number of public health issues. The situation in these resource-limited countries is scary due to the huge burden of infectious diseases like tuberculosis (TB). The latest reports from the WHO shows a high number of drug resistant cases even in the pediatric age groups. Also, the lack of suspicion of drug resistant TB (DR-TB) in the pediatric cases, especially in the absence of a past or family history may lead to delay in diagnosis and flaring-up of the disease. We herein present the very first case of the primary multidrug-resistant TB in an HIV negative child who presented with the left sided pleural effusion...
January 2017: Translational pediatrics
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