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临床试验/NCT00728117
NCT00728117已完成不适用

Should Very Low Birth Weight Infants Receive Enteral Nutrition During Indomethacin or Ibuprofen Treatment of a Patent Ductus Arteriosus? A Multi-Center Randomized Controlled Trial

University of California, San Francisco27 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
177
试验地点
27
主要终点
Assess the effect of feeding infants during indomethacin or ibuprofen therapy on the incidence of feeding intolerance and the number of days required to achieve full feedings (120 ml/kg/day).

研究概览

简要总结

We hypothesize that feeding preterm infants while they receive indomethacin or ibuprofen therapy for treatment of a patent ductus arteriosus will decrease the incidence of feeding intolerance and shorten the time period that infants need to tolerate full enteral nutrition. We also hypothesize that this intervention will minimize the alterations in intestinal permeability that occur with these drugs and will improve the infants' hemodynamic response to enteral nutrition

详细描述

This study is a randomized controlled multi-center clinical trial to determine whether very low birth weight infants should receive feedings during indomethacin or ibuprofen treatment of a patent ductus arteriosus (PDA). Many neonatologists withhold feeds from premature infants receiving indomethacin or ibuprofen therapy for a PDA because of concerns that these drugs alter intestinal blood flow and permeability. However, there are no established studies which show that feeding during these medical treatments leads to bowel injury. At the same time, studies suggest that withholding feedings from premature infants may lead to intestinal atrophy and injury, leading to increased difficulty with feedings when they are initiated or re-started. Thus, this multi-center study evaluates whether feeding infants during indomethacin or ibuprofen therapy improves feeding tolerance by measuring the number of episodes of feeding intolerance and the number of days required to attain full feedings. In addition, this study will employ techniques to measure gastrointestinal permeability and mesenteric blood flow in patients who receive and don't receive feedings for their PDA treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
23 Weeks 至 33 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Infants between 401-1,250 g birth weight who
  • Are receiving or are scheduled to begin enteral feedings and
  • Are about to receive pharmacologic treatment (either indomethacin or ibuprofen) to close their PDA.

排除标准

  • Serious congenital malformations
  • Chromosomal anomalies
  • Congenital or acquired gastrointestinal anomalies
  • Prior episode of necrotizing enterocolitis
  • Use of inotropic support for hypotension
  • Renal anomalies or disease
  • Are receiving > 80 ml/kg/d of enteral feeding

结局指标

主要结局

Assess the effect of feeding infants during indomethacin or ibuprofen therapy on the incidence of feeding intolerance and the number of days required to achieve full feedings (120 ml/kg/day).

时间窗: 4 years

次要结局

  • incidence of necrotizing enterocolitis or spontaneous perforation(4 years)
  • Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on intestinal permeability.(4 years)
  • Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on the normal hyperemic response to feeding.(4 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (27)

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