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临床试验/NCT00926276
NCT00926276已完成4 期

The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia (BPD).

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2009年6月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
2
试验地点
2
主要终点
Evaluate the efficacy of fundoplication in premature infants with GERD and BPD.

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of fundoplication in premature infants with GERD and BPD.

详细描述

Gastroesophageal reflux disease (GERD) has been postulated to result in chronic aspiration contributing to the development of chronic lung disease, otherwise known as bronchopulmonary dysplasia (BPD) in premature infants. This association has been indirectly based on anecdotal improvement in the respiratory status of infants with BPD after anti-reflux therapy, but the direct causal relationship has been difficult to prove. In addition, the historical evidence for infants with GERD has been based on acid reflux only which is diagnosed by 24 hour intra-esophageal pH monitoring, the gold standard. However, with the introduction of multi-channel intraluminal impedance (MII), GERD can now include non-acid reflux. The contribution of non-acid reflux to the development of BPD in premature infants is unknown. As our understanding of GERD has improved, previous assumptions regarding the efficacy of therapy may no longer be valid. The utilization of anti-reflux surgery (fundoplication) for the treatment of BPD in premature infants with GERD has not been rigorously studied. The efficacy of fundoplication in this patient population has yet to be determined.

研究设计

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

入排标准

年龄范围
24 Weeks 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Must meet all inclusion criteria for Initial Evaluation of GERD
  • Positive pH-MII test for GERD
  • Upper GI contrast radiograph to evaluate for associated congenital gastrointestinal anomalies
  • > or = 2 kg (due to technical limitations of fundoplication)

排除标准

  • Previous intra-abdominal surgery except for gastrostomy
  • Those deemed not surgical candidates
  • Infants with associated congenital gastrointestinal anomalies
  • > or = 1 year of age at time of Initial Evaluation of GERD

结局指标

主要结局

Evaluate the efficacy of fundoplication in premature infants with GERD and BPD.

时间窗: Three months

次要结局

  • Establish preliminary data regarding the correlation between acid and non-acid GERD and pepsin from tracheal aspirates as a marker of chronic aspiration in premature infants with BPD.(Six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

KuoJen Tsao

Assistant Professor - Pediatric Surgery

The University of Texas Health Science Center, Houston

研究点 (2)

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