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View article: Mapping the rare disease paediatric clinical trial availabilities in Europe
Mapping the rare disease paediatric clinical trial availabilities in Europe Open
Introduction The prevalence and complexity of rare diseases (RDs) require concerted efforts in research and clinical trial capabilities. This paper aims to map the clinical trial sites within the Collaborative Network for European Clinical…
View article: Diagnosis, management and treatment of the Alport syndrome – 2024 guideline on behalf of ERKNet, ERA and ESPN
Diagnosis, management and treatment of the Alport syndrome – 2024 guideline on behalf of ERKNet, ERA and ESPN Open
Glomerular nephropathy resulting from the genetic defects in COL4A3/4/5 genes including the classical Alport syndrome is the second most common hereditary kidney disease characterized by persistent haematuria progressing to the need for ki…
View article: Partnership of I-ACT for children (US) and European pediatric clinical trial networks to facilitate pediatric clinical trials
Partnership of I-ACT for children (US) and European pediatric clinical trial networks to facilitate pediatric clinical trials Open
Background/aims Due to a lack of standard pediatric prescribing information, medicines are often used in a dosage form or for an indication that has not been investigated in children. Pediatric clinical trial research networks aim to facil…
View article: Assessment of Within- and Inter-Patient Variability of Uremic Toxin Concentrations in Children with CKD
Assessment of Within- and Inter-Patient Variability of Uremic Toxin Concentrations in Children with CKD Open
To promote improved trial design in upcoming randomized clinical trials in childhood chronic kidney disease (CKD), insight in the within- and inter-patient variability of uremic toxins with its nutritional, treatment- and patient-related c…
View article: 31 An update on the challenges of conducting pediatric clinical trials: 15 years of progress since EMA regulation implementation
31 An update on the challenges of conducting pediatric clinical trials: 15 years of progress since EMA regulation implementation Open
Background/Aims Still 60% of drugs used in children are off label. Although the EMA regulation, increased largely the timely submission of Pediatric Investigational plans (PIP) and initiation of clinical trials (CT), the majority of these …
View article: 32 Empowering the next generation: how the young ESDPPP community is nurturing young paediatricians and pharmacology experts
32 Empowering the next generation: how the young ESDPPP community is nurturing young paediatricians and pharmacology experts Open
Research Objectives Informal networking with colleagues, including teachings of vast evolving novel technologies within pharmacometrics, has been identified as essential in all stages of a paediatric and pharmacology career. Young research…
View article: 29 Five-year report on the activities of the Connect4Children (c4c) European paediatric clinical trials network in Belgium
29 Five-year report on the activities of the Connect4Children (c4c) European paediatric clinical trials network in Belgium Open
Background/Aims Currently, over 60% of clinical trials in children are unsuccessful due to insufficient recruitment, administrative burden, inadequate methodology, among other reasons. Sponsors experience difficulties identifying adequate …
View article: Metabolic Acidosis Is Associated With an Accelerated Decline of Allograft Function in Pediatric Kidney Transplantation
Metabolic Acidosis Is Associated With an Accelerated Decline of Allograft Function in Pediatric Kidney Transplantation Open
The degree of metabolic acidosis is associated with allograft dysfunction.
View article: Development and performance of the c4c national clinical trial networks for optimizing pediatric trial facilitation
Development and performance of the c4c national clinical trial networks for optimizing pediatric trial facilitation Open
Introduction The high failure rate of industry-driven pediatric clinical trials leads to insufficient timely labeling of drugs in children and a lack of scientific evidence, resulting in the persistently high off-label drug use. National c…
View article: Time-Varying Determinants of Graft Failure in Pediatric Kidney Transplantation in Europe
Time-Varying Determinants of Graft Failure in Pediatric Kidney Transplantation in Europe Open
Background Little is known about the time-varying determinants of kidney graft failure in children. Methods We performed a retrospective study of primary pediatric kidney transplant recipients (younger than 18 years) from the Eurotransplan…
View article: Population pharmacokinetics of lisinopril in hypertensive children and adolescents with normal to mildly reduced kidney function
Population pharmacokinetics of lisinopril in hypertensive children and adolescents with normal to mildly reduced kidney function Open
Aims Lisinopril, an angiotensin‐converting enzyme inhibitor, is a frequently prescribed antihypertensive drug in the paediatric population, while being used off‐label under the age of 6 years in the USA and for all paediatric patients glob…
View article: Mental health and professional outcomes in parents of children with chronic kidney disease
Mental health and professional outcomes in parents of children with chronic kidney disease Open
Background This study evaluated stress, anxiety and depression symptoms and their associated factors in parents of children with chronic kidney disease (CKD). Methods This cross-sectional study compared parents of CKD patients (0–18 years)…
View article: Population pharmacokinetics of lisinopril in hypertensive children and adolescents with normal to mildly reduced kidney function
Population pharmacokinetics of lisinopril in hypertensive children and adolescents with normal to mildly reduced kidney function Open
Background: Lisinopril, an angiotensin-converting enzyme inhibitor (ACEi), is a frequently prescribed antihypertensive drug in the pediatric population, while being used off-label under the age of 6 years in the US and for all pediatric pa…
View article: 9 The flood of study feasibilities and the value of a centralised approach
9 The flood of study feasibilities and the value of a centralised approach Open
Introduction Due to an increase in multicentric paediatric clinical trials after 2007 following the EU Paediatric Regulation, there has been a substantial increase in the number of feasibility questionnaires (FQ). Paediatric clinical trial…
View article: 10 Paediatric clinical trial needs and requirements within Belgium
10 Paediatric clinical trial needs and requirements within Belgium Open
Introduction Due to the Paediatric Regulation in 2007, the number of paediatric clinical trials within Europe has substantially increased. Consequently, potential sites for paediatric clinical trials were overrun by trial opportunities, in…
View article: The efficacy of standard urotherapy in the treatment of nocturnal enuresis in children: A systematic review
The efficacy of standard urotherapy in the treatment of nocturnal enuresis in children: A systematic review Open
The number of clinical studies on standard urotherapy in children with NE is limited and many of them are of poor quality. High quality research in a well-defined NE population is needed to establish the role of standard urotherapy in firs…
View article: Definition, diagnosis and clinical management of non-obstructive kidney dysplasia: a consensus statement by the ERKNet Working Group on Kidney Malformations
Definition, diagnosis and clinical management of non-obstructive kidney dysplasia: a consensus statement by the ERKNet Working Group on Kidney Malformations Open
Kidney dysplasia is one of the most frequent causes of chronic kidney failure in children. While dysplasia is a histological diagnosis, the term ‘kidney dysplasia’ is frequently used in daily clinical life without histopathological confirm…
View article: Mental Health Outcomes Among Parents of Children With a Chronic Disease During the COVID-19 Pandemic: The Role of Parental Burn-Out
Mental Health Outcomes Among Parents of Children With a Chronic Disease During the COVID-19 Pandemic: The Role of Parental Burn-Out Open
Objective The COVID-19 pandemic and associated quarantine measures highly impacted parental psychological well-being. Parents of children with chronic diseases might be specifically vulnerable as they already face multiple challenges to pr…
View article: Nocturnal bladder emptying and Quality of Life in patients with spinal cord injury
Nocturnal bladder emptying and Quality of Life in patients with spinal cord injury Open
The use of suprapubic catheterization should be considered to improve Quality of Life for tetraplegic patients. For paraplegic patients, we must focus urological policy on aiming to reduce the number of nighttime bladder emptying to one or…
View article: Towards an Algorithm-Based Tailored Treatment of Acute Neonatal Hyperammonemia
Towards an Algorithm-Based Tailored Treatment of Acute Neonatal Hyperammonemia Open
Acute neonatal hyperammonemia is associated with poor neurological outcomes and high mortality. We developed, based on kinetic modeling, a user-friendly and widely applicable algorithm to tailor the treatment of acute neonatal hyperammonem…