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Children and clinical trials

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https://www.readbyqxmd.com/read/28546755/pediatric-ventricular-assist-devices-current-challenges-and-future-prospects
#1
REVIEW
Sarah Burki, Iki Adachi
The field of mechanical circulatory support has made great strides in the preceding 2 decades. Although pediatric mechanical circulatory support has lagged behind that of adults, the gap between them is expected to close soon. The only device currently approved by the US Food and Drug Administration for use in children is the Berlin Heart EXCOR ventricular assist device (VAD). The prospective Berlin Heart Investigational Device Exemption Trial demonstrated good outcomes, such as bridge to transplantation or recovery, in ~90% of children supported with this device...
2017: Vascular Health and Risk Management
https://www.readbyqxmd.com/read/28546375/extracorporeal-membrane-oxygenation-for-severe-pediatric-respiratory-failure
#2
John C Lin
Extracorporeal membrane oxygenation (ECMO) was developed initially in the 1960s to support refractory respiratory failure in addition to the cardiac support inherent in a venoarterial bypass circuit. Early successes occurred predominantly in the neonatal population with subsequent randomized controlled trials and comprehensive reviews concluding therapeutic efficacy for ECMO in neonatal respiratory failure. In contrast, the evidence supporting ECMO for respiratory failure in children is less definitive. However, although pediatric randomized controlled trials have not been completed, sufficient evidence in support of ECMO as a beneficial therapy for pediatric respiratory failure exists...
June 2017: Respiratory Care
https://www.readbyqxmd.com/read/28545823/novel-molecular-subgroups-for-clinical-classification-and-outcome-prediction-in-childhood-medulloblastoma-a-cohort-study
#3
Edward C Schwalbe, Janet C Lindsey, Sirintra Nakjang, Stephen Crosier, Amanda J Smith, Debbie Hicks, Gholamreza Rafiee, Rebecca M Hill, Alice Iliasova, Thomas Stone, Barry Pizer, Antony Michalski, Abhijit Joshi, Stephen B Wharton, Thomas S Jacques, Simon Bailey, Daniel Williamson, Steven C Clifford
BACKGROUND: International consensus recognises four medulloblastoma molecular subgroups: WNT (MBWNT), SHH (MBSHH), group 3 (MBGrp3), and group 4 (MBGrp4), each defined by their characteristic genome-wide transcriptomic and DNA methylomic profiles. These subgroups have distinct clinicopathological and molecular features, and underpin current disease subclassification and initial subgroup-directed therapies that are underway in clinical trials. However, substantial biological heterogeneity and differences in survival are apparent within each subgroup, which remain to be resolved...
May 22, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28545757/a-randomized-clinical-trial-comparing-family-focused-treatment-and-individual-supportive-therapy-for-depression-in-childhood-and-early-adolescence
#4
Martha C Tompson, Catherine A Sugar, David A Langer, Joan R Asarnow
OBJECTIVE: Despite the morbidity and negative outcomes associated with early-onset depression, few studies have examined the efficacy of psychosocial treatment for depressive disorders during childhood. Integrating family in treatment could have particularly salutary effects during this developmental period. This trial compared immediate posttreatment effects of family-focused treatment for childhood depression (FFT-CD) with those of individual supportive psychotherapy (IP) for children 7 to 14 years old with depressive disorders...
June 2017: Journal of the American Academy of Child and Adolescent Psychiatry
https://www.readbyqxmd.com/read/28543302/a-randomised-controlled-trial-of-an-ipad-based-application-to-complement-early-behavioural-intervention-in-autism-spectrum-disorder
#5
Andrew J O Whitehouse, Joanna Granich, Gail Alvares, Margherita Busacca, Matthew N Cooper, Alena Dass, Thi Duong, Rajes Harper, Wendy Marshall, Amanda Richdale, Tania Rodwell, David Trembath, Pratibha Vellanki, Dennis W Moore, Angelika Anderson
BACKGROUND: Technology-based interventions for Autism Spectrum Disorder (ASD) have proliferated, but few have been evaluated within the context of a randomised controlled trial (RCT). This RCT evaluated the efficacy of one technology-based early intervention programme (Therapy Outcomes By You; TOBY) in young children with ASD. METHODS: TOBY is an app-based learning curriculum designed for children and parents as a complement to early behavioural intervention. Eighty children (16 female) were recruited to this RCT within 12 months of receiving a diagnosis of ASD (M age = 3...
May 25, 2017: Journal of Child Psychology and Psychiatry, and Allied Disciplines
https://www.readbyqxmd.com/read/28543191/methadone-buprenorphine-and-naltrexone-for-the-treatment-of-opioid-use-disorder-in-pregnant-women
#6
Tran H Tran, Brooke L Griffin, Rebecca H Stone, Kathleen M Vest, Timothy J Todd
Pregnant women with opioid use disorder can be treated with methadone, buprenorphine, or naltrexone to reduce opioid use and improve retention to treatment. In this review, we compare the pregnancy outcomes of methadone, buprenorphine, and naltrexone in clinical trials and discuss the potential behavioral and developmental effects of these agents seen in offspring in animal studies. Important clinical considerations in the management of opioid use disorder in pregnant women and their infants are also discussed...
May 24, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/28542078/a-population-level-investigation-of-cancer-clinical-trials-participation-in-a-uk-region
#7
Conan B Donnelly, Amy C Wotherspoon, Melanie Morris, Richard H Wilson, Jingwen J Chen, Victoria Cairnduff, Eileen Morgan, Amy Devlin, Anna T Gavin
The aim of this study was to document cancer trial participation since establishment of the Northern Ireland Cancer Trials Network and investigate population and disease factors associated with trial participation. An independent cohort of over 51 000 cancer patients from the Northern Ireland Cancer Registry covering the same population (2007-2012) was linked to a database of 1316 interventional cancer trial participants in a UK region. The primary outcome measure was participation in an intervention clinical trial...
May 24, 2017: European Journal of Cancer Prevention
https://www.readbyqxmd.com/read/28542043/induction-therapy-with-biosimilar-infliximab-in-children-with-crohn-s-disease
#8
Joanna Sieczkowska-Golub, Monika Meglicka, Anna Plocek, Aleksandra Banaszkiewicz, Dorota Jarzębicka, Ewa Toporowska-Kowalska, Agnieszka Gawronska, Grzegorz Oracz, Jaroslaw Kierkus
INTRODUCTION: In most European countries, an infliximab biosimilar (CT-P13) is currently in common use. In vitro and in vivo studies have proved a high similarity between CT-P13 and the reference infliximab. CT-P13 was licensed for use in patients with Crohn's diseases (CD) based on the extrapolation of data from preclinical studies and clinical trials in rheumatology indications. The aim of this study was to assess the similarity between CT-P13 and the originator infliximab in induction therapy in CD paediatric patients...
May 24, 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28540807/technical-aspects-of-osteoid-osteoma-ablation-in-children-using-mr-guided-high-intensity-focussed-ultrasound
#9
Pavel S Yarmolenko, Avinash Eranki, Ari Partanen, Haydar Celik, AeRang Kim, Matthew Oetgen, Viktoriya Beskin, Domiciano Santos, Janish Patel, Peter C W Kim, Karun Sharma
BACKGROUND: Osteoid osteoma (OO) is a painful bone tumour occurring in children and young adults. Magnetic resonance imaging-guided high intensity focussed ultrasound (MR-HIFU) allows non-invasive treatment without ionising radiation exposure, in contrast to the current standard of care treatment with radiofrequency ablation (RFA). This report describes technical aspects of MR-HIFU ablation in the first 8 paediatric OO patients treated in a safety and feasibility clinical trial (total enrolment of up to 12 patients)...
April 24, 2017: International Journal of Hyperthermia
https://www.readbyqxmd.com/read/28540638/in-silico-dose-prediction-for-long-acting-rilpivirine-and-cabotegravir-administration-to-children-and-adolescents
#10
Rajith K R Rajoli, David J Back, Steve Rannard, Caren Freel Meyers, Charles Flexner, Andrew Owen, Marco Siccardi
BACKGROUND AND OBJECTIVES: Long-acting injectable antiretrovirals represent a pharmacological alternative to oral formulations and an innovative clinical option to address adherence and reduce drug costs. Clinical studies in children and adolescents are characterised by ethical and logistic barriers complicating the identification of dose optimisation. Physiologically-based pharmacokinetic modelling represents a valuable tool to inform dose finding prior to clinical trials. The objective of this study was to simulate potential dosing strategies for existing long-acting injectable depot formulations of cabotegravir and rilpivirine in children and adolescents (aged 3-18 years) using physiologically-based pharmacokinetic modelling...
May 24, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28540436/premedication-with-melatonin-vs-midazolam-efficacy-on-anxiety-and-compliance-in-paediatric-surgical-patients
#11
Pietro Impellizzeri, Enrica Vinci, Maria Cristina Gugliandolo, Francesca Cuzzocrea, Rosalba Larcan, Tiziana Russo, Maria Rosaria Gravina, Salvatore Arena, Gabriella D'Angelo, Eloisa Gitto, Angela Simona Montalto, Angela Alibrandi, Lucia Marseglia, Carmelo Romeo
Preoperative anxiety is a major problem in paediatric surgical patients. Melatonin has been used as a premedicant agent and data regarding effectiveness are controversial. The primary outcome of this randomized clinical trial was to evaluate the effectiveness of oral melatonin premedication, in comparison to midazolam, in reducing preoperative anxiety in children undergoing elective surgery. As secondary outcome, compliance to intravenous induction anaesthesia was assessed. There were 80 children undergoing surgery randomly assigned, 40 per group, to receive oral midazolam (0...
May 24, 2017: European Journal of Pediatrics
https://www.readbyqxmd.com/read/28539993/effectiveness-of-non-pharmacological-interventions-on-stereotyped-and-repetitive-behaviors-of-pre-school-children-with-autism-a-systematic-review
#12
REVIEW
Hadi Zarafshan, Maryam Salmanian, Soudeh Aghamohammadi, Mohammad Reza Mohammadi, Seyed-Ali Mostafavi
INTRODUCTION: The present study aimed to review the literature on non-pharmacological interventions used to treat stereotyped and repetitive behaviors by a systematic method. METHODS: Two authors independently performed a search strategy on Medline/PubMed, Scopus and PsycINFO on English articles published up to April 23, 2014 with relevant search keywords. We also reviewed the bibliographies of retrieved articles and conference proceedings to obtain additional citations and references...
March 2017: Basic and Clinical Neuroscience
https://www.readbyqxmd.com/read/28539444/improved-prefusion-stability-optimized-codon-usage-and-augmented-virion-packaging-enhance-the-immunogenicity-of-respiratory-syncytial-virus-rsv-fusion-protein-in-a-vectored-vaccine-candidate
#13
Bo Liang, Joan O Ngwuta, Sonja Surman, Barbora Kabatova, Xiang Liu, Matthias Lingemann, Xueqiao Liu, Lijuan Yang, Richard Herbert, Joanna Swerczek, Man Chen, Syed M Moin, Azad Kumar, Jason S McLellan, Peter D Kwong, Barney S Graham, Peter L Collins, Shirin Munir
Respiratory syncytial virus (RSV) is the most important viral agent of severe pediatric respiratory tract disease worldwide, but lacks a licensed vaccine or suitable antiviral drug. A live-attenuated chimeric bovine/human parainfluenza virus type-3 (rB/HPIV3) was developed previously as a vector expressing RSV fusion (F) protein to confer bivalent protection against RSV and HPIV3. In a previous clinical trial in virus-naïve children, rB/HPIV3 was well-tolerated but the immunogenicity of wildtype RSV F was unsatisfactory...
May 24, 2017: Journal of Virology
https://www.readbyqxmd.com/read/28539196/effects-of-the-informed-health-choices-podcast-on-the-ability-of-parents-of-primary-school-children-in-uganda-to-assess-claims-about-treatment-effects-a-randomised-controlled-trial
#14
Daniel Semakula, Allen Nsangi, Andrew D Oxman, Matt Oxman, Astrid Austvoll-Dahlgren, Sarah Rosenbaum, Angela Morelli, Claire Glenton, Simon Lewin, Margaret Kaseje, Iain Chalmers, Atle Fretheim, Doris Tove Kristoffersen, Nelson K Sewankambo
BACKGROUND: As part of the Informed Health Choices project, we developed a podcast called The Health Choices Programme to help improve the ability of people to assess claims about the benefits and harms of treatments. We aimed to evaluate the effects of the podcast on the ability of parents of primary school children in Uganda to assess claims about the effects of treatments. METHODS: We did this randomised controlled trial in central Uganda. We recruited parents of children aged 10-12 years who were in their fifth year of school at 35 schools that were participating in a linked trial of the Informed Health Choices primary school resources...
May 19, 2017: Lancet
https://www.readbyqxmd.com/read/28539194/effects-of-the-informed-health-choices-primary-school-intervention-on-the-ability-of-children-in-uganda-to-assess-the-reliability-of-claims-about-treatment-effects-a-cluster-randomised-controlled-trial
#15
Allen Nsangi, Daniel Semakula, Andrew D Oxman, Astrid Austvoll-Dahlgren, Matt Oxman, Sarah Rosenbaum, Angela Morelli, Claire Glenton, Simon Lewin, Margaret Kaseje, Iain Chalmers, Atle Fretheim, Yunpeng Ding, Nelson K Sewankambo
BACKGROUND: Claims about what improves or harms our health are ubiquitous. People need to be able to assess the reliability of these claims. We aimed to evaluate an intervention designed to teach primary school children to assess claims about the effects of treatments (ie, any action intended to maintain or improve health). METHODS: In this cluster-randomised controlled trial, we included primary schools in the central region of Uganda that taught year-5 children (aged 10-12 years)...
May 19, 2017: Lancet
https://www.readbyqxmd.com/read/28538871/what-do-cochrane-systematic-reviews-say-about-interventions-for-autism-spectrum-disorders
#16
Larissa Lyra, Luiz Eduardo Rizzo, Camila Sá Sunahara, Daniela Vianna Pachito, Carolina de Oliveira Cruz Latorraca, Ana Luiza Cabrera Martimbianco, Rachel Riera
CONTEXT AND OBJECTIVE: Autism spectrum disorders (ASDs) include autistic disorder, Asperger's disorder and pervasive developmental disorder. The manifestations of ASDs can have an important impact on learning and social functioning that may persist during adulthood. The aim here was to summarize the evidence from Cochrane systematic reviews on interventions for ASDs. DESIGN AND SETTING: Review of systematic reviews, conducted within the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo...
March 2017: São Paulo Medical Journal, Revista Paulista de Medicina
https://www.readbyqxmd.com/read/28538622/towards-precision-medicine-accurate-predictive-modeling-of-infectious-complications-in-combat-casualties
#17
Christopher J Dente, Matthew Bradley, Seth Schobel, Beverly Gaucher, Timothy Buchman, Allan D Kirk, Eric Elster
BACKGROUND: The biomarker profile of trauma patients may allow for the creation of models to assist bedside decision making & prediction of complications. We sought to determine the utility of modeling in the prediction of bacteremia & pneumonia in combat casualties. METHODS: This is a prospective, observational trial of patients with complex wounds treated at Walter Reed National Military Medical Center (2007-2012). Tissue, serum and wound effluent samples were collected during operative interventions until wound closure...
May 22, 2017: Journal of Trauma and Acute Care Surgery
https://www.readbyqxmd.com/read/28538329/perioperative-care-for-pediatric-patients-with-penetrating-brain-injury-a-review
#18
Marco Mikhael, Elizabeth Frost, Maria Cristancho
Traumatic brain injury (TBI) continues to be the leading cause of death and acquired disability in young children and adolescents, due to blunt or penetrating trauma, the latter being less common but more lethal. Penetrating brain injury (PBI) has not been studied extensively, mainly reported as case reports or case series, due to the assumption that both types of brain injury have common pathophysiology and consequently common management. However, recommendations and guidelines for the management of PBI differ from those of blunt TBI in regards to neuroimaging, intracranial pressure (ICP) monitoring, and surgical management including those pertaining to vascular injury...
May 19, 2017: Journal of Neurosurgical Anesthesiology
https://www.readbyqxmd.com/read/28537583/impact-of-the-n-6-n-3-long-chain-pufa-ratio-during-pregnancy-and-lactation-on-offspring-neurodevelopment-5-year-follow-up-of-a-randomized-controlled-trial
#19
C Brei, L Stecher, S Brunner, R Ensenauer, F Heinen, P D Wagner, J Hermsdörfer, H Hauner
BACKGROUND/OBJECTIVES: Evidence regarding the effect of n-3 long-chain polyunsaturated fatty acid (LCPUFA) supplementation during pregnancy on offspring's neurodevelopment is not conclusive. SUBJECTS/METHODS: In this analysis, the effect of a reduced n-6:n-3 LCPUFA ratio in the diet of pregnant/lactating women (1.2 g n-3 LCPUFA together with an arachidonic acid (AA)-balanced diet between 15th wk of gestation-4 months postpartum vs control diet) on child neurodevelopment at 4 and 5 years of age was assessed...
May 24, 2017: European Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28536925/parental-perspectives-on-pharmacological-clinical-trials-a-qualitative-study-in-down-syndrome-and-fragile-x-syndrome
#20
Victoria Reines, Krista Charen, Tracie Rosser, Arri Eisen, Stephanie L Sherman, Jeannie Visootsak
Research studies focusing on parents' perspectives of pharmacological clinical trials have not kept pace with the number of emerging pharmacologic clinical trials in Down syndrome (DS) and Fragile X syndrome (FXS). Since individuals with DS or FXS have limited cognitive ability to make decisions about their participation in clinical trials, it is important to consider the parents' perspectives and explore the ways in which decisions are made for their children. Using a semi-structured interview, we enrolled 9 parents of a child(ren) with FXS and 15 with a child with DS to analyze their views, experiences, and knowledge of pharmacological clinical trials...
May 24, 2017: Journal of Genetic Counseling
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