Deferred Consent in Pediatric Drug Trials: Moving from Why to How
(Source: Pediatric Drugs)
Source: Pediatric Drugs - October 28, 2021 Category: Pediatrics Source Type: research
Randomized Clinical Trial of Metoclopramide as Prophylaxis of Gastroesophageal Reflux Disease in Preterm Infants
ConclusionResults show absence of effectiveness in the systematic use of metoclopramide as prophylaxis of GERD symptoms in premature infants. Additionally, no adverse effects attributable to the drug were found.ClinicalTrials.gov: NCT02907632; September 20, 2016. Retrospectively registered. (Source: Pediatric Drugs)
Source: Pediatric Drugs - October 25, 2021 Category: Pediatrics Source Type: research
Acknowledgement to Referees
(Source: Pediatric Drugs)
Source: Pediatric Drugs - October 25, 2021 Category: Pediatrics Source Type: research
Medical Management of Infantile Hemangiomas: An Update
AbstractInfantile hemangioma (IH) is the most common benign vascular tumor of infancy, affecting about 5% of infants. It has a characteristic growth pattern of early rapid proliferation followed by progressive involution. Although most IH evolve favorably, complications are observed in 10 –15% of cases, justifying treatment. For over 10 years now, propranolol has become the first-line therapy for complicated IH, revolutionizing their management and their prognosis. In this article, we review the clinical features, associations, complications/sequelae and therapeutic approaches for IH, focusing on current medical therapy....
Source: Pediatric Drugs - October 22, 2021 Category: Pediatrics Source Type: research
Secukinumab: A Review in Moderate to Severe Pediatric Plaque Psoriasis
In conclusion, secukinumab represents a valuable new addition to the limited treatment options available for children and adolescents with moderate to severe plaque psoriasis. (Source: Pediatric Drugs)
Source: Pediatric Drugs - October 19, 2021 Category: Pediatrics Source Type: research
Deferred Consent in Neonatal Clinical Research: Why, When, How?
We present a framework based on neonatal deferred consent trials that assess both non-drug and drug interventions, our experience conducting deferred consent neonatal studies in Australia, and the views of providers and parents on how to best implement deferred consent in the neonatal research setting. (Source: Pediatric Drugs)
Source: Pediatric Drugs - October 15, 2021 Category: Pediatrics Source Type: research
Use of Furosemide and Chlorothiazide Combination Continuous Infusion in Furosemide-Refractory Patients in the Pediatric Intensive Care Unit: A Retrospective Cohort Study
ConclusionsFCCCI resulted in a significant improvement in diuresis with achievement of negative fluid balance in pediatric ICU patients. FCCCI is a reasonable approach to aggressive diuresis in the pediatric patient, particularly in patients with limited access. Serum potassium should be routinely monitored during such therapy. (Source: Pediatric Drugs)
Source: Pediatric Drugs - October 11, 2021 Category: Pediatrics Source Type: research
Correction to: Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia
(Source: Pediatric Drugs)
Source: Pediatric Drugs - October 7, 2021 Category: Pediatrics Source Type: research
Teriflunomide: Pediatric First Approval
This article summarizes the milestones in the development of teriflunomide leading to this first pediatric approval for relapsing-remitting MS. (Source: Pediatric Drugs)
Source: Pediatric Drugs - October 1, 2021 Category: Pediatrics Source Type: research
Managing Adverse Events Associated with Dinutuximab Beta Treatment in Patients with High-Risk Neuroblastoma: Practical Guidance
AbstractNeuroblastoma is the most common extracranial solid tumour in children, accounting for 15% of all paediatric cancer deaths. High-risk neuroblastoma is a particularly challenging-to-treat form of disease that requires multimodality treatment, consisting of chemotherapy, surgery, high-dose chemotherapy with autologous haematopoietic stem cell rescue, radiotherapy and differentiation therapy. However, despite intense multimodal treatment regimens, the prognosis for this patient population remains poor. In recent years, immunotherapy with anti-disialoganglioside 2 (anti-GD2) antibodies was found to improve survival rat...
Source: Pediatric Drugs - September 20, 2021 Category: Pediatrics Source Type: research
Executive Function Outcome of Treatment with Viloxazine Extended-Release Capsules in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Post-Hoc Analysis of Four Randomized Clinical Trials
ConclusionConsistent with the efficacy of viloxazine ER demonstrated in pivotal trials, viloxazine ER significantly reduced EFDs in subjects with ADHD. Moreover, a substantial proportion of subjects treated with viloxazine ER had large improvements in EFDs, ADHD symptoms, or both.Clinical Trial Registration NumbersNCT03247530, NCT03247517, NCT03247543, NCT03247556. (Source: Pediatric Drugs)
Source: Pediatric Drugs - September 15, 2021 Category: Pediatrics Source Type: research
Laboratory Safety of Dupilumab in Patients Aged 6 –11 Years with Severe Atopic Dermatitis: Results from a Phase III Clinical Trial
ConclusionThere were no clinically meaningful adverse changes in routine laboratory parameters attributable to treatment with dupilumab + TCS. Changes in platelet counts and lactate dehydrogenase levels likely reflect reduced inflammation. These results confirm similar findings in adults and adolescents, and suggest that there is no need for routine laboratory monitoring of children aged 6 –11 years treated with dupilumab + TCS for severe AD.Trial RegistrationClinicalTrials.gov Identifier: NCT03345914.Video abstractDoes treatment with dupilumab require routine laboratory monitoring in 6- to 11-year-old children with seve...
Source: Pediatric Drugs - August 31, 2021 Category: Pediatrics Source Type: research
Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia
AbstractCommunity-acquired pneumonia (CAP)/community-acquired bacterial pneumonia (CABP) and complicated skin and soft tissue infection (cSSTI)/acute bacterial skin and skin structure infection (ABSSSI) represent major causes of morbidity and mortality in children. β-Lactams are the cornerstone of antibiotic treatment for many serious bacterial infections in children; however, most of these agents have no activity against methicillin-resistantStaphylococcus aureus (MRSA). Ceftaroline fosamil, a β-lactam with broad-spectrum in vitro activity against Gram-positive pathogens (including MRSA and multidrug-resistantStreptococ...
Source: Pediatric Drugs - August 31, 2021 Category: Pediatrics Source Type: research
Potential Antibiotics for the Treatment of Neonatal Sepsis Caused by Multidrug-Resistant Bacteria
We describe the available characteristics of each in terms of mechanism of action, resistance mechanisms, clinical pharmacokinetics, pharmacodynamics, and toxicity profile. We also identify some knowledge gaps: (1) the neonatal pharmacokinetics of cefepime is reliant on relatively small and limited datasets, and the pharmacokinetics of flomoxef are also reliant on data from a limited demographic range and (2) for all reviewed agents, the pharmacodynamic index and target has not been definitively established for both bactericidal effect and emergence of resistance, with many assumed to have an identical index/target to simi...
Source: Pediatric Drugs - August 26, 2021 Category: Pediatrics Source Type: research
Targeted Therapy in Pediatric AML: An Evolving Landscape
AbstractThe outcomes associated with pediatric acute myeloid leukemia (AML) have improved over the last few decades, with the implementation of intensive chemotherapy, hematopoietic stem cell transplant, and improved supportive care. However, even with intensive therapy and the use of HSCT, both of which carry significant risks of short- and long-term side effects, approximately 30% of children are not able to be cured. The characterization of AML in pediatrics has evolved over time and it currently involves use of a variety of diagnostic tools, including flow cytometry and comprehensive genomic sequencing. Given the adver...
Source: Pediatric Drugs - August 22, 2021 Category: Pediatrics Source Type: research
