CTRI/2025/07/091255尚未招募不适用
Role of Proton Pump Inhibitors in prevention of Anastomotic Stricture in patients of Esophageal Atresia: A Pilot Randomized Controlled Trial
Dr Aditya Shastri1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To study the incidence of anastomotic stricture in operated cases of Esophageal atresia receiving Proton pump inhibitors and in control group
研究概览
简要总结
A pilot randomized controlled trial to evaluate the efficacy of Proton pump inhibitors in reducing the incidence of anastomotic stricture in operated neonates of Esophageal atresia and to study their effect on the gut microbiome. This study will also assess the impact of Proton pump inhibitors on clinical symptoms after discharge such as swallowing difficulty, episodes of respiratory infections, number of hospitalisations needed and requirement of esophageal dilatation if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 6.00 Month(s)（—）
- 性别
- All
入选标准
- •1.Neonates born at or after 35 weeks of gestation, in whom primary anastomosis has been done.
- •Neonates born at or after 35 weeks of gestation, without any associated anomalies.
排除标准
- •Neonates of Type C Esophageal Atresia undergoing Esophagostomy + Gastrostomy instead of primary anastomosis.
- •Neonates with anastomotic leak managed either conservatively or undergoing diversion procedure.
- •Other varieties of EA except Type-C.
- •Preterm babies with Type-C esophageal atresia.
结局指标
主要结局
To study the incidence of anastomotic stricture in operated cases of Esophageal atresia receiving Proton pump inhibitors and in control group
时间窗: Till 6 months post operatively
次要结局
- To study the incidence of swallowing difficulty, episodes of respiratory infections,(hospitalizations needed, requirement of dilatations in operated cases of Esophageal atresia receiving Proton pump ihibitors and in control group)
研究者
Aditya Shastri
Post Graduate Institute of Medical Education and Research, Chandigarh
研究点 (1)
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