title: The protocol for a randomised-controlled trial of the evaluation of the tolerance and safety of early enteral nutrition in children after percutaneous endoscopic gastrostomy placement. (protocol version 09.01.2015).
abstract: The appropriate time to initiate enteral nutrition after the placement of a percutaneous endoscopic gastrostomy (PEG) tube has been an area of limited research. There are no sufficient randomised prospective controlled trials in the paediatric population comparing the safety and tolerance of early feeding (3 h) after PEG placement. In order to reduce the period of fasting, inadequate nutritional support, and hospitalisation time, we decided to devise this study.
  
  
  
  This study is a multicentre, randomised, open-label trial designed to evaluate the tolerance and safety of early enteral nutrition after PEG placement in children. Patients are randomised to receive the first feeding bolus with a polymeric diet (1 kcal/ml) via a feeding tube 3 h after the PEG placement (group I - early enteral feeding) or 8 h after the procedure (group II - late enteral feeding). The key objective of the study is to compare the tolerance and safety of the early- and late-feeding modes after PEG placement in children. The primary endpoint is the number of patients who will achieve full feed (total fluid and caloric requirements) within 48 h of the first feeding bolus. The secondary endpoints are: the number of early and late complications, the duration of hospitalisation after PEG placement, gastric residuals (ml) total in the period up to 48 h since the first feeding bolus.
  
  
  
  To our knowledge this is the first study in paediatric patients to evaluate the tolerance and safety of early enteral nutrition after PEG placement. The goal is to establish an optimum standard procedure in the group of paediatric patients qualified for the PEG insertion procedure in Poland.
  
  
  
  ClinicalTrials.gov ID NCT02777541 , registration date 05/18/2016.
authors.affiliation: Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute, Aleja Dzieci Polskich 20, 04-730, Warsaw, Poland.
authors.forename: Anna
authors.initials: A
authors.lastname: Wiernicka
authors.affiliation: Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute, Aleja Dzieci Polskich 20, 04-730, Warsaw, Poland.
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Matuszczyk
authors.affiliation: Department of Pediatrics, Gastroenterology, Hepatology and Nutrition, Medical University of Gdańsk, Gdańsk, Poland.
authors.forename: Agnieszka
authors.initials: A
authors.lastname: Szlagatys-Sidorkiewicz
authors.affiliation: Department of Alergology, Gastroenterology and Nutrition, Medical University, Łódź, Poland.
authors.forename: Ewa
authors.initials: E
authors.lastname: Toporowska-Kowalska
authors.affiliation: Department of Pediatrics, Nutrition and Metabolic Disorders, The Children's Memorial Health Institute, Warsaw, Poland.
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Popińska
authors.affiliation: Department of Pediatrics, Medical University of Silesia, Katowice, Poland.
authors.forename: Urszula
authors.initials: U
authors.lastname: Chlebowczyk-Grzybowska
authors.affiliation: Department of Pediatrics and Gastroenterology, Area Hospital in Toruń, Toruń, Poland.
authors.forename: Ewa
authors.initials: E
authors.lastname: Hapyn
authors.affiliation: Department of Gastroenterology, Hepatology and Feeding Disorders, The Children's Memorial Health Institute, Aleja Dzieci Polskich 20, 04-730, Warsaw, Poland. j.kierkus@ipczd.pl.
authors.forename: Jarosław
authors.initials: J
authors.lastname: Kierkuś
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D004750:Enteral Nutrition / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D005773:Gastroscopy; D005774:Gastrostomy / Q000379:methods; D006801:Humans; D007223:Infant; D007441:Intubation, Gastrointestinal / Q000379:methods; D008297:Male; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D013997:Time Factors
keywords: Children; Early enteral nutrition; Percutaneous endoscopic gastrostomy placement