Evaluation of Tolerance and Safety of Early Enteral Nutrition in Children After Percutaneous Endoscopic Gastrostomy Placement
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of patients who will achieve full feed (total fluid and caloric requirements) within 48 hours since the first feeding bolus.
研究概览
简要总结
There aren't sufficient randomized prospective controlled trials in pediatric population comparing the safety and tolerance of early feeding after PEG placement (3-4 hours). Most patients are fasted for at least 12 hours following percutaneous endoscopic gastrostomy. In order to decrease the period of fasting, inadequate nutritional support, and hospitalization time, the investigators decided to design this study. The additional goal is to establish an optimum standard procedure in the group of pediatric patients qualified for PEG insertion procedure in Poland.
详细描述
This study is a multicentre, randomized, open label trial designed to evaluate the tolerance and safety of early enteral nutrition after PEG placement in children. Recruitment will be from patients attending the one of six medical centers in Poland: Department of Gastroenterology, Hepatology and Feeding Disorders and Department of Pediatrics, The Children's Memorial Health Institute in Warsaw, Department of Pediatrics, Gastroenterology, Hepatology and Nutrition, Medical University of Gdańsk in Gdańsk, Department of Allergology, Gastroenterology and Nutrition, Medical University in Łódź, Department of Pediatrics, Medical University of Silesia in Katowice and Department of Pediatrics and Gastroenterology, Area Hospital in Torus.
The trial will include 100 patients, from 1-month-old to 18-year-old, qualified for percutaneous endoscopic gastrostomy (PEG) placement. All participants will be prepared for the procedure according to the standard medical protocol.
Parents/legal guardians, and where possible also the patient, will be informed about the research plan, and after signed informed consent to participate in the study patients will be enrolled for the study. At the Baseline visit participants will be randomized (1:1) to one of two treatment group: Group I- early enteral feeding group (3 hours after PEG implantation) or Group II- late enteral feeding group (8 hours after PEG implantation). The follow-up visits in hospital is planned 3, 6, 9 mad 12 months after the procedure in all subjects.
Primary endpoint:
- Number of patients who will achieve full feed (total fluid and caloric requirements) within 48 hours since the first feeding bolus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between 1 month-old and 18 years-old
- •Medical indications for percutaneous endoscopic gastrostomy (PEG) placement.
- •Informed consent to participate in the study signed and dated by the subject's parent/legal guardian and the also by patient over the age of 16 years.
排除标准
- •Serious, uncorrectable coagulation disorders.
- •Inability to perform upper gastrointestinal (UGI) series endoscopy (laryngeal or oesophageal stricture)
- •Need for concomitant fundoplication.
- •Lack of technical ability to perform PEG placement procedure
结局指标
主要结局
Number of patients who will achieve full feed (total fluid and caloric requirements) within 48 hours since the first feeding bolus.
时间窗: 48 hours
次要结局
- Number of early complications (to 6 days after PEG placement)(to 6 days after PEG placement)
- Number of late complications ( 7 days - 12 months after PEG placement)(7 days- 12 months after PEG placement)
- Number of hospitalization days after PEG placement(up to 30 days)
- Gastric residuals (ml) - sum up to 48 hours since the first feeding bolus(48 hours)
研究者
JAROSLAW KIERKUS
PhD
Children's Memorial Health Institute, Poland