Good Clinical Practice

Understanding the safety and efficacy of protocols associated with therapeutic compounds currently in development is of great importance. Clinical guidelines provide the standards for the clinical trials and the current effort is toward an international harmonization of guidelines. It is important for the general pediatricians to be informed about ethical and scientific quality standards used for designing, conducting, recording and reporting trials that involve participation of human subjects to ensure that the rights, safety and wellbeing of the trial subjects are protected.

Since the 7th Europaediatrics, the biannual European Meeting of EPA-UNEPSA, our Association, has established a fruitful collaboration with the major European Pediatric Specialty Societies, with the aim to disseminate proper scientific and educational information leading to best practice in paediatrics . A constant monitoring of the latest guidelines in Good Clinical Practice in paediatrics issued by the collaborating specialty organizations is performed by EPA-UNEPSA and the link to important guidelines and statements documents is made available on this website in order to provide the European Paediatric Community with relevant information, useful to further promote a good clinical practice in paediatrics.

Gastroenterology (click here)

• ESPGHAN Position statement on the management of Percutaneous Endoscopic Gastrostomy in children and adolescents
J Pediatr Gastroenterol Nutrition. 2015; 60 (1): 131-141
• Management Guidelines of Eosinophilic Esophagitis (EoE) in Childhood
J Pediatr Gastroenterol Nutr. 2014; 58(1): 107-18
• ESPGHAN guidelines for the diagnosis of coeliac disease.
J Pediatr Gastroenterol Nutr. 2012; 54(1): 136-60
• ESPGHAN/ESPID Evidence-based Guidelines for the Management of Acute Gastroenteritis in Children in Europe. Update 2014
J Pediatr Gastroenterol Nutr. 2014; 59(1): 132-52
• Diagnostic Approach and Management of Cow's-Milk Protein Allergy in Infants and Children: ESPGHAN GI Committee Practical Guidelines
J Pediatr Gastroenterol Nutr. 2012; 55(2): 221-9
• Indications, Methodology, and Interpretation of Combined Esophageal Impedance-pH Monitoring in Children: ESPGHAN EURO-PIG Standard Protocol
J Pediatr Gastroenterol Nutr. 2012; 55(2): 230-4
• Management of Pediatric Ulcerative Colitis: Joint ECCO and ESPGHAN Evidence-based Consensus Guidelines
J Pediatr Gastroenterol Nutr. 2012; 55(3): 340-61
• Risk of Infection and Prevention in Pediatric Patients With IBD: ESPGHAN IBD Porto Group Commentary
J Pediatr Gastroenterol Nutr 2012; 54 (6): 830-837
• ESPGHAN Guidelines for the Diagnosis of Coeliac Disease
J Pediatr Gastroenterol Nutr. 2012; 54: 136–160
• Evidence-based Guidelines From ESPGHAN and NASPGHAN for Helicobacter pylori Infection in Children
J Pediatr Gastroenterol Nutr. 2011; 53(2): 230-43
• The ESPGHAN Cystic Fibrosis Working Group: defining DIOS and constipation in cystic fibrosis with a multicenter study on the incidence, characteristics, and treatment of DIOS.
J Pediatr Gastroenterol Nutr. 2010 Jan; 50(1): 8
J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):38-42
• Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the NASPGHAN and the ESPGHAN
J Pediatr Gastroenterol Nutr. 2009; 49(4): 498-547
• ESPGHAN/ESPID Evidence-based Guidelines for the Management of Acute Gastroenteritis in Children in Europe
J Pediatr Gastroenterol Nutr. 2008;46 Suppl 2: vii-viii.

Hepatology (click here)

• Intestinal Failure associated liver disease (IFALD): ESPGHAN position paper
J Pediatr Gastroenterol Nutrition. 2015; 60 (2): 272-283
• Liver Biopsy in Children: Position Paper of the ESPGHAN Hepatology Committee
J Pediatr Gastroenterol Nutr. 2015;60: 408–420
• Diagnosis of Nonalcoholic Fatty Liver Disease in Children and Adolescents: Position Paper of the ESPGHAN Hepatology Committee
J Pediatr Gastroenterol Nutr. 2012; 54: 700–713
• Guidance for Clinical Trials for Children and Adolescents With Chronic Hepatitis C
J Pediatr Gastroenterol Nutr. 2011;52: 233–237

Nutrition (click here)

• Arsenic in rice: a cause for concern
J Pediatr Gastroenterol Nutr 2015; 60: 142-5
• Use of Probiotics for Management of Acute Gastroenteritis: A Position Paper by the ESPGHAN Working Group for Probiotics and Prebiotics
J Pediatr Gastroenterol Nutrition. 2014; 58 (4): 531-539
• Iron requirements of infants and toddlers.
J Pediatr Gastroenterol Nutr 2014; 58: 119-29
• Donor human milk for preterm infants: current evidence and research directions.
J Pediat Gastroenterol Nutr 2013; 57: 535-42
• World Health Organization 2006 child growth standards and 2007 growth reference charts: A discussion paper by the committee on Nutrition of the ESPGHAN.
J Pediatr Gastroenterol Nutr 2013; 57: 258-64
• Vitamin D in the healthy European paediatric population.
J Pediatr Gastroenterol Nutr 2013; 56: 692-701
• Supplementation of N-3 LCPUFA to the Diet of Children Older Than 2 Years: A Commentary by the ESPGHAN Committee on Nutrition
J Pediatr Gastroenterol Nutr. 2011; 53(1): 2-10
• Role of Dietary Factors and Food Habits in the Development of Childhood Obesity: A Commentary by the ESPGHAN Committee on Nutrition
J Pediatr Gastroenterol Nutr. 2011; 52(6): 662-9
• Supplementation of Infant Formula With Probiotics and/or Prebiotics: A Systematic Review and Comment by the ESPGHAN Committee on Nutrition
J Pediatr Gastroenterol Nutr. 2011; 52(2): 238-50
• Practical Approach to Paediatric Enteral Nutrition: A Comment by the ESPGHAN Committee on Nutrition
J Pediatr Gastroenterol Nutr. 2010; 51(1): 110-22
• Enteral Nutrient Supply for Preterm Infants: Commentary from the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition Committee on Nutrition
J Pediatr Gastroenterol Nutr. 2010; 50(1): 85-91
• ESPGHAN Committee on Nutrition: Breastfeeding
J Pediatr Gastroenterol Nutr. 2009; 49(1): 112-125
• ESPGHAN Committee on Nutrition: Complementary Feeding: A Commentary by the ESPGHAN Committee on Nutrition.
J Pediatr Gastroenterol Nutr. 2008; 46: 99-110.

Endocrinology (click here)

Statements
• Consensus Statement of Minimal Acceptable Care in Paediatric Endocrinology (Microsoft Powerpoint document) (1.2mb)
• Consensus statement on the management of the GH-treated adolescent in the transition to adult care (PDF) (92kb)
• Consensus Statement on 21-Hydroxylase Deficiency from The European Society for Paediatric Endocrinology and The Lawson Wilkins Pediatric Endocrine Society (PDF) (79kb)
• ESPE/LWPES consensus statement on diabetic ketoacidosis in children and adolescents (web link http://adc.bmjjournals.com/cgi/content/full/89/2/188?ijkey=iJ5K6/M7LeI/Y... )
• Consensus statement on management of intersex disorders (pdf) (363kb)
Online edition available in Archives of Disease in Childhood www.archdischild.com

Nephrology (click here)

• Guidelines by an ad hoc European committee for elective chronic peritoneal dialysis in pediatric patients. Perit Dial Int 2001; 21: 240-244.
• Guidelines by an ad hoc European committee on the assessment of growth and nutritional status in children on chronic peritoneal dialysis.
• The choice of dialysis solutions in pediatric chronic peritoneal dialysis: guidelines by an ad hoc European committee. Perit Dial Int 2001; 21: 568-574.
• Guidelines by an ad hoc European Committee on adequacy of the paediatric peritoneal dialysis prescription. Nephrol Dial Transpl 2002; 17: 380-385.
• The management of anaemia in pediatric peritoneal dialysis patients. Guidelines by an ad hoc European committee. Pediatr Nephrol 2003; 18: 805-809.
• Renal Replacement therapy for acute renal failure in children: European guidelines. Pediatr Nephrol 2004;19:199-207.
• Haemodialysis in children: general practical guidelines. Pediatr Nephrol 2005;20:1054-1066.
• Prevention and treatment of renal osteodystrophy in children on chronic renal failure: European guidelines. Pediatric Nephrology 2006:21(2);151-159.
• Solutions for peritoneal dialysis in children: recommendations by the European Pediatric Dialysis Working Group. Pediatric Nephrology DOI 10.1007/s00467-011-1863-4.

EUROPEAN SOCIETY FOR PAEDIATRIC ANAESTHESIOLOGY
ESPA Guidelines (click here)

• Emergency Care
• National Guidelines
• Safety
• Treatment
• US Regional Anaesthesia
• US Vascular Access
• ESPA Pain Section