The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia (BPD).
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
- 否
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
KuoJen Tsao
Assistant Professor - Pediatric Surgery
The University of Texas Health Science Center, Houston
