NCT00213668已完成4 期
Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates
University Hospital, Rouen2 个研究点 分布在 1 个国家开始时间: 2002年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
- 主要终点
- gastric emptying
研究概览
简要总结
This study investigates the effects of enterally supplied glutamine on gastric emptying, intestinal transit, age of total enteral nutrition and age at the end of hospitalisation. Forty neonates, aged at least 2 days and free of acute illness participate in a prospective, randomised, double-blind study. All are fed with parenteral and enteral nutrition enriched with glutamine (0.7 g/kg/per day, group 1) or isonitrogenous control (group 2). Gastric emptying is analysed by sequential measure of intragastric residue by diluted polyethylene glycol (PEG) 4000. Intestinal transit is analysed by Rouge Carmin test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 2 Days 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature neonates aged 30-33 weeks of gestational age
- •Aged at least 2 days and no more than 10 days
- •Free of acute illness
- •Written informed consent is obtained from the parent prior to enrolment.
排除标准
- •Premature infants with respiratory (fraction of inspired oxygen [FiO2] > 30%), or cardiovascular, liver, intestinal or acute diseases
- •Premature infants with congenital syndrome
结局指标
主要结局
gastric emptying
时间窗: at day 0, day 1, day 7 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product
次要结局
- age of total enteral nutrition
- date and duration of arrest of nutrition if necessary
- variation of cholescystokinin and gastrin postprandial concentration(at day 0 and day 14)
- intestinal transit(at day 1 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product)
- age at the end of hospitalization
研究者
研究点 (2)
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