Treatment Options in Pediatric Beh çet’s Disease
AbstractBeh çet’s disease is a rare and poorly understood vasculitis affecting blood vessels of all types and sizes. Uveitis and oral and genital ulcers represent the typical clinical triad. Populations along the ancient trading route connecting the Mediterranean basin with the Middle and Far East are most a ffected. Up to a quarter of the cases has a pediatric onset, typically around puberty. The aim of the treatment is early intervention to control inflammation, with symptom relief and prevention of relapses, damage, and complications. The heterogeneous clinical presentation often requires a multidisc iplinary and tai...
Source: Pediatric Drugs - January 10, 2023 Category: Pediatrics Source Type: research

Letermovir for Prophylaxis and Pre-emptive Therapy of Cytomegalovirus Infection in Paediatric Allogeneic Haematopoietic Cell Transplant Patients
ConclusionLetermovir was effective in controlling CMV infection in seropositive paediatric allogeneic HCT recipients and was  overall well tolerated. Pending completion of the still ongoing paediatric investigation plans, letermovir will be an important adjunct to our options for control of infectious complications in this special population. (Source: Pediatric Drugs)
Source: Pediatric Drugs - December 27, 2022 Category: Pediatrics Source Type: research

Laboratory Safety from a Randomized 16-Week Phase III Study of Dupilumab in Children Aged 6 Months to 5 Years with Moderate-to-Severe Atopic Dermatitis
ConclusionsThese results suggest that routine laboratory monitoring of children aged 6 months to<  6 years treated with dupilumab plus topical corticosteroids is not required. Limitations of this study include short study duration, and exclusion of patients with abnormalities in laboratory test results at screening.Clinical Trial RegistrationClinicalTrials.gov: NCT03346434, part B (Source: Pediatric Drugs)
Source: Pediatric Drugs - December 19, 2022 Category: Pediatrics Source Type: research

Characterization of Cardiac Function by Echocardiographic Global Longitudinal Strain in a Cohort of Children with Neurofibromatosis Type 1 Treated with Selumetinib
ConclusionsPatients with NF1 treated with selumetinib may experience subtle changes in systolic function identified by global longitudinal strain and not revealed by left ventricular ejection fraction. Global longitudinal strain might be useful to monitor cardiac function in this cohort of patients for the duration of therapy. (Source: Pediatric Drugs)
Source: Pediatric Drugs - December 18, 2022 Category: Pediatrics Source Type: research

Treatment Options for Juvenile Pityriasis Rubra Pilaris
AbstractPityriasis rubra pilaris represents a group of familial and acquired disorders of cornification that affect both adult and pediatric patients. Treatment options are difficult to assess through clinical trials, given the rarity of the disorder and its tendency for spontaneous remission. Case reports and case series are therefore the primary means of assessment. Because of the heterogeneity of the disease, there is no universal approach to treatment, and multiple agents may need to be trialed to achieve disease control. At present, topicals are used for most pediatric patients, though monotherapy with topicals is onl...
Source: Pediatric Drugs - December 18, 2022 Category: Pediatrics Source Type: research

Sodium Thiosulfate: Pediatric First Approval
This article summarizes the milestones in the development of sodium thiosulfate leading to this pediatric first approval for reducing the risk of ototoxicity associated with cisplatin in pediatric patients. (Source: Pediatric Drugs)
Source: Pediatric Drugs - December 15, 2022 Category: Pediatrics Source Type: research

Acknowledgement to Referees
(Source: Pediatric Drugs)
Source: Pediatric Drugs - December 12, 2022 Category: Pediatrics Source Type: research

Interventions for the Management of Pain and Sedation in Newborns Undergoing Therapeutic Hypothermia for Hypoxic-Ischemic Encephalopathy: A Systematic Review
ConclusionsWe found limited evidence to establish the benefits and harms of the interventions for the management of pain and sedation in newborn infants undergoing TH. Long-term outcomes were not reported. Given the very low certainty of evidence —due to imprecision of the estimates, inconsistency and limitations in study design (all nine observational studies with overall serious risk of bias)—for all outcomes, clinical trials are required to determine the most effective interventions in this population.Systematic Review RegistrationPROSPERO registration number: CRD42020205755. (Source: Pediatric Drugs)
Source: Pediatric Drugs - December 8, 2022 Category: Pediatrics Source Type: research

Perioperative Indications for Gabapentinoids in Pediatrics: A Narrative Review
AbstractIn recent years, there has been increased interest in using gabapentinoids (gabapentin and pregabalin) as part of multimodal medication plans or enhanced recovery after surgery protocols to mitigate several perioperative clinical challenges. Outcomes explored in the context of using gabapentinoids perioperatively in children are variable and include acute complications of pain, anxiety, nausea and vomiting, and emergence agitation, as well as the long-term postoperative outcome of chronic postsurgical pain. This narrative review describes the current literature regarding perioperative use of gabapentinoids in pedia...
Source: Pediatric Drugs - November 25, 2022 Category: Pediatrics Source Type: research

Multidisciplinary Clinical Care in the Management of Patients Receiving Anti-GD2 Immunotherapy for High-Risk Neuroblastoma
AbstractThe addition of anti-disialoganglioside-2 (GD2) monoclonal antibodies (mAbs) such as dinutuximab and naxitamab to standard therapies for high-risk (HR) neuroblastoma has significantly improved outcomes for children with this devastating disease. The care for these young patients receiving treatment for HR neuroblastoma is complex, with need for the involvement of a multidisciplinary team. Clinical implementation of anti-GD2 mAb treatment requires the same harmonized team approach. The authors share the development process of this coordinated team method and practical recommendations for administration of anti-GD2 m...
Source: Pediatric Drugs - November 25, 2022 Category: Pediatrics Source Type: research

Efficacy and Safety of the Adjuvant Use of Probiotic Bacillus clausii Strains in Pediatric Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study
ConclusionNo significant differences in efficacy betweenB. clausii and placebo were demonstrated in addition to conventional treatment. The sample size calculation was based on an expected placebo/conventional treatment response of 30 –40%. However, the actual treatment response observed was 80% and, thus, a study with larger population would be warranted. In addition, this study was conducted during the COVID-19 pandemic, when such controlled social conditions may have resulted in better diet, greater family stability, less ps ychological stress, and lower risk of infections exacerbating IBS, thereby improving symptoms ...
Source: Pediatric Drugs - November 16, 2022 Category: Pediatrics Source Type: research

Adverse Drug Reactions in Children: Comparison of Reports Collected in a Pharmacovigilance Project Versus Spontaneously Collected ADR Reports
ConclusionIn general, reports from both data sources contributed to the identification of ADRs and dedicated issues related to drug therapy. However, these differed by nature and strength of the signal, likely due to the characteristics of the individual method. A combined approach could likely compensate for limitations inherent to the single approaches, but will most likely only be applied to dedicated pharmacovigilance topics or research objectives. (Source: Pediatric Drugs)
Source: Pediatric Drugs - November 12, 2022 Category: Pediatrics Source Type: research

Ibrutinib: Pediatric First Approval
This article summarizes the milestones in the development of ibrutinib leading to this pediatric first approval for the treatment of patients with cGVHD. (Source: Pediatric Drugs)
Source: Pediatric Drugs - November 10, 2022 Category: Pediatrics Source Type: research

Trends in Adverse Drug Reactions Among Children: Evidence from Jiangsu Province of China, 2010 –2019
ConclusionsADRs remain a public health challenge among the vulnerable pediatric populations. Findings from the present study call for continuing efforts in ADR prevention and medication safety improvement in children. (Source: Pediatric Drugs)
Source: Pediatric Drugs - November 2, 2022 Category: Pediatrics Source Type: research

Pharmacokinetics of l-Citrulline in Neonates at Risk of Developing Bronchopulmonary Dysplasia-Associated Pulmonary Hypertension
ConclusionThis is the first PK study in neonates presenting data that can be used to inform dosing strategies in future randomized controlled trials evaluating enterall-citrulline as a potential treatment to reduce PH associated with BPD in premature neonates.RegistrationClinical trials.gov Identifier: NCT03542812. (Source: Pediatric Drugs)
Source: Pediatric Drugs - October 31, 2022 Category: Pediatrics Source Type: research