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pediatrics RCT

Joanne Blair, Andrew McKay, Colin Ridyard, Keith Thornborough, Emma Bedson, Matthew Peak, Mohammed Didi, Francesca Annan, John W Gregory, Dyfrig Hughes, Carrol Gamble
BACKGROUND: The risk of developing long-term complications of type 1 diabetes (T1D) is related to glycaemic control and is reduced by the use of intensive insulin treatment regimens: multiple daily injections (MDI) (≥ 4) and continuous subcutaneous insulin infusion (CSII). Despite a lack of evidence that the more expensive treatment with CSII is superior to MDI, both treatments are used widely within the NHS. OBJECTIVES: (1) To compare glycaemic control during treatment with CSII and MDI and (2) to determine safety and cost-effectiveness of the treatment, and quality of life (QoL) of the patients...
August 2018: Health Technology Assessment: HTA
Kishore Mulpuri, Emily K Schaeffer, James Sanders, Ira Zaltz, Mininder S Kocher
BACKGROUND: The evidence-based approach to guide clinical practice has gained great importance in the medical field. High-quality evidence is of paramount importance to inform clinical decision-making and optimize patient outcomes. The generation of high-quality evidence relies on sound methodology and study design to facilitate appropriate interpretation and subsequent application of the clinical findings. The purpose of this review is to objectively critique the methodological design and clinical findings of 2 pediatric orthopaedic studies on children with cerebral palsy (CP) to assess their potential to impact clinical practice...
August 1, 2018: Journal of Pediatric Orthopedics
Marisa Tucci, Jacques Lacroix, Dean Fergusson, Allan Doctor, Paul Hébert, Robert A Berg, Jaime Caro, Cassandra D Josephson, Stéphane Leteurtre, Kusum Menon, Kenneth Schechtman, Marie E Steiner, Alexis F Turgeon, Lucy Clayton, Tina Bockelmann, Philip C Spinella
BACKGROUND: The "Age of Blood in Children in Pediatric Intensive Care Unit" (ABC PICU) study is a randomized controlled trial (RCT) that aims to determine if red blood cell (RBC) unit storage age affects outcomes in critically ill children. While RBCs can be stored for up to 42 days in additive solutions, their efficacy and safety after long-term storage have been challenged. Preclinical and clinical observational evidence suggests loss of efficacy and lack of safety of older RBC units, especially in more vulnerable populations such as critically ill children...
July 28, 2018: Trials
Deborah Ford, Rebecca Turner, Anna Turkova, Martina Penazzato, Victor Musiime, Mutsa Bwakura-Dangarembizi, Avy Violari, Chishala Chabala, Thanyawee Puthanakit, Tavitiya Sudjaritruk, Tim R Cressey, Marc Lallemant, Diana M Gibb
For HIV-infected children, formulation development, pharmacokinetic (PK) data, and evaluation of early toxicity are critical for licensing new antiretroviral drugs; direct evidence of efficacy in children may not be needed if acceptable safety and PK parameters are demonstrated in children. However, it is important to address questions where adult trial data cannot be extrapolated to children. In this fast-moving area, interventions need to be tailored to resource-limited settings where most HIV-infected children live and take account of decreasing numbers of younger HIV-infected children after successful prevention of mother-to-child HIV transmission...
August 15, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
Yuko Shima, Koichi Nakanishi, Yoshitsugu Kaku, Kenji Ishikura, Hiroshi Hataya, Takeshi Matsuyama, Masataka Honda, Mayumi Sako, Kandai Nozu, Ryojiro Tanaka, Kazumoto Iijima, Norishige Yoshikawa
BACKGROUND: Two previous randomized controlled trials showed that treatment of severe childhood immunoglobulin A (IgA) nephropathy using prednisolone with azathioprine, heparin-warfarin, or dipyridamole prevented the increase of sclerosed glomeruli. Prednisolone alone, however, did not prevent further increase. These studies indicated the importance of immunosuppressants in the treatment. An additional pilot study using mizoribine instead of azathioprine enabled us to complete 2 years of combined regimen...
July 9, 2018: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
Vitchayaporn Emarach Saengow, Phanusorn Chancharoenchai, Weeraphat Saartying, Watcharapong Pimpa, Napat Chotichanon, Thanat Lewsirirat, Phuwadech Srisantisuk
OBJECTIVES: Insufficient of knowledge of epilepsy causes poor drug adherence and seizure control. Leading us to create video animation to educate epilepsy patients and caregivers and evaluate the benefit of this video. PATIENTS AND METHODS: The 8.52-min video animation was created to provide fundamental information regarding diagnosis, treatment and drug usage for pediatric epilepsy patients. The impact of this video animation was evaluated in a randomized controlled trial (RCT) study during June- September 2016...
June 30, 2018: Clinical Neurology and Neurosurgery
Sariah Khormaee, Judy Choe, Joseph J Ruzbarsky, Kunal N Agarwal, John S Blanco, Shevaun M Doyle, Emily R Dodwell
BACKGROUND: The randomized controlled trial (RCT) is the gold standard study design allowing critical comparison of clinical outcomes while minimizing bias. Traditionally clinical trials are evaluated through statistical significance, expressed by P-values and confidence intervals. However, until recently, the robustness of a study's conclusions has been given little attention. A new metric, the fragility index, quantifies the number of patients theoretically required to switch outcomes in order to reverse the study conclusions...
July 3, 2018: Journal of Pediatric Orthopedics
Jorrit W van As, Henk van den Berg, Elvira C van Dalen
BACKGROUND: Platinum-based therapy, including cisplatin, carboplatin or oxaliplatin, or a combination of these, is used to treat a variety of paediatric malignancies. Unfortunately, one of the most important adverse effects is the occurrence of hearing loss or ototoxicity. In an effort to prevent this ototoxicity, different platinum infusion durations have been studied. This review is the second update of a previously published Cochrane review. OBJECTIVES: To assess the effects of different durations of platinum infusion to prevent hearing loss or tinnitus, or both, in children with cancer...
July 5, 2018: Cochrane Database of Systematic Reviews
Daniela B Hauschild, Luna D A Oliveira, Mirelle S Farias, Eliana Barbosa, Nilzete L Bresolin, Nilesh M Mehta, Yara M F Moreno
BACKGROUND: Loss of muscle mass in critically ill children can negatively impact outcomes. The aims of this study were to conduct a pilot randomized control trial (RCT) to examine the difference in protein delivery and nitrogen balance in critically ill children with enteral protein supplementation vs controls. We also aimed to assess the feasibility, safety, and tolerance of the pilot trial. METHODS: This is a 3-arm RCT in critically ill children eligible for enteral nutrition (EN) therapy...
June 30, 2018: JPEN. Journal of Parenteral and Enteral Nutrition
Kusum Menon, Dayre McNally, Anand Acharya, Katharine O'Hearn, Karen Choong, Hector R Wong, Lauralyn McIntyre, Margaret Lawson
Background The aim of the study was to examine the relationship between serum total cortisol (TC) and free cortisol (FC) levels in children with septic shock and the relationship of these levels with baseline illness severity. Methods A sub-study of a randomized controlled trial (RCT) of hydrocortisone vs. placebo in pediatric septic shock conducted in seven academic pediatric intensive care units (PICUs) in Canada on children aged newborn to 17 years. Thirty children with septic shock had serum sent for TC and FC measurement within 6 h of meeting the study eligibility criteria...
July 26, 2018: Journal of Pediatric Endocrinology & Metabolism: JPEM
Simona Silvetti, Tommaso Aloisio, Anna Cazzaniga, Marco Ranucci
BACKGROUND: Placement of central venous catheters (CVCs) is essential and routine practice in the management of children with congenital heart disease. The purpose of the present protocol is to evaluate the risk for infectious complications in terms of catheter colonization, catheter line-associated bloodstream infections, and catheter-related bloodstream infections (CRBSIs), and the mechanical complications from different central venous access sites in infants and newborns undergoing cardiac surgery...
June 25, 2018: Trials
Stephen J Chester, Zephanie Tyack, Alexandra De Young, Belinda Kipping, Bronwyn Griffin, Kellie Stockton, Robert S Ware, Xi Zhang, Roy M Kimble
No randomized controlled trial (RCT) has investigated the efficacy of hypnosis for reducing pain and improving healing in children with burns. This RCT aimed to investigate whether hypnosis decreases pain, anxiety and stress and accelerates wound-healing in children undergoing burn wound procedures. Children (4 to 16 years) with acute burns presenting for their first dressing change were randomly assigned to a Hypnosis Group who received hypnosis plus standard care or a Standard Care Group who received standard pharmacological and non-pharmacological intervention...
June 21, 2018: Pain
Maru Barrera, Eshetu Atenafu, Paul C Nathan, Fiona Schulte, Kelly Hancock
Objective: The objective of this study was to (1) assess the effects of a group intervention called Siblings Coping Together on siblings' psychosocial adjustment compared with controls; (2) explore the potential moderating effect of siblings' gender; and (3) investigate whether the intervention was more effective for siblings with more depressive symptoms at baseline. Methods: This was a repeated measure, parallel randomized controlled trial (RCT) with two groups...
June 8, 2018: Journal of Pediatric Psychology
Krithika Lingappan, Jennifer L Arnold, Caraciolo J Fernandes, Mohan Pammi
BACKGROUND: Establishment of a secure airway is a critical part of neonatal resuscitation in the delivery room and the neonatal unit. Videolaryngoscopy has the potential to facilitate successful endotracheal intubation and decrease adverse consequences of delay in airway stabilization. Videolaryngoscopy may enhance visualization of the glottis and intubation success in neonates. OBJECTIVES: To determine the efficacy and safety of videolaryngoscopy compared to direct laryngoscopy in decreasing the time and attempts required for endotracheal intubation and increasing the success rate at first intubation in neonates...
June 4, 2018: Cochrane Database of Systematic Reviews
Patrick Scheiermann, Friederike Herzog, Andrea Siebenhofer, Reinhard Strametz, Tobias Weberschock
STUDY OBJECTIVE: General anesthesia is commonly used in pediatric inpatient surgery. It can be induced and maintained by either intravenous or volatile anesthetic agents. We aimed to elucidate whether intravenous or volatile anesthetic agents are superior with regards to preventing anesthesia-related complications. DESIGN: Using a predefined standardized study protocol we conducted a systematic review of randomized controlled trials (RCTs) with meta-analysis where appropriate searching the following data bases: CENTRAL, MEDLINE, EMBASE, metaRegister of Controlled Trials (until June 2016)...
September 2018: Journal of Clinical Anesthesia
Nicholas Feinberg, Hiroko Matsumoto, Chun Wai Hung, Tricia St Hilaire, Jeff Pawelek, Jeffrey R Sawyer, Behrooz A Akbarnia, David L Skaggs, Benjamin D Roye, David P Roye, Michael G Vitale
STUDY DESIGN: Expert consensus building using combined Delphi method and Nominal group technique. OBJECTIVES: To identify the current state of equipoise surrounding the use of magnetically controlled growing rods (MCGRs) and to determine consensus for planning a randomized controlled trial (RCT) with MCGRs. BACKGROUND: The use of MCGRs for the treatment of early-onset scoliosis (EOS) is a new technology. Optimal use has not been thoroughly investigated and much uncertainty exists...
May 2018: Spine Deformity
Varsha Chayapathi, Manas Kalra, Anita S Bakshi, Amita Mahajan
BACKGROUND: Both ketamine-midazolam and propofol are frequently used in pediatric oncology units for procedural sedation. However, there are no prospective, randomized comparative trials (RCT) comparing the two groups when the procedure is performed by nonanesthesiologists. OBJECTIVE: To compare ketamine + midazolam (group A) and propofol (group B) as sedative agents for intrathecal chemotherapy with regard to efficacy, side effects, time to induction, time to recovery, and smoothness of recovery...
August 2018: Pediatric Blood & Cancer
Margherita Gobbo, Federico Verzegnassi, Luca Ronfani, Davide Zanon, Fraia Melchionda, Simone Bagattoni, Alessandra Majorana, Elena Bardellini, Rosamaria Mura, Alessandra Piras, Maria Grazia Petris, Maria Livia Mariuzzi, Angelica Barone, Elisabetta Merigo, Nunzia Decembrino, Marina Consuelo Vitale, Massimo Berger, Patrizia Defabianis, Matteo Biasotto, Giulia Ottaviani, Giulio Andrea Zanazzo
OBJECTIVES: To demonstrate the efficacy of laser photobiomodulation (PBM) compared to that of placebo on severe oral mucositis (OM) in pediatric oncology patients. The primary objective was the reduction of OM grade (World Health Organization [WHO] scale) 7 days after starting PBM. Secondary objectives were reduction of pain, analgesic consumption, and incidence of side effects. METHODS: One hundred and one children with WHO grade > 2 chemotherapy-induced OM were enrolled in eight Italian hospitals...
August 2018: Pediatric Blood & Cancer
Edouard Dufetelle, Geert W 't Jong, Florentia Kaguelidou
OBJECTIVE: Conduct of clinical trials is perceived to be more challenging in children than in adults. This study aimed to evaluate the impact of the age of participants on completion rates of randomized controlled trials (RCTs). STUDY DESIGN AND SETTING: A cross-sectional study on RCTs registered in the database. All RCTs registered up to December 31, 2016, were extracted and were classified according to their recruitment status: active, completed, or discontinued and according to the age of participants: children (<17 years), adults (≥18 years), and mixed-age population...
August 2018: Journal of Clinical Epidemiology
Srinivasan Suresh, Richard A Saladino, Janet Fromkin, Emily Heineman, Tom McGinn, Rudolph Richichi, Rachel P Berger
Objective: To evaluate the effect of a previously validated electronic health record-based child abuse trigger system on physician compliance with clinical guidelines for evaluation of physical abuse. Methods: A randomized controlled trial (RCT) with comparison to a preintervention group was performed. RCT-experimental subjects' providers received alerts with a direct link to a physical abuse-specific order set. RCT-control subjects' providers had no alerts, but could manually search for the order set...
July 1, 2018: Journal of the American Medical Informatics Association: JAMIA
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