Evaluation of Smectite Effect As A Food Thickener On Gastroesophageal Reflux Disease In Neonates Using Combined Esophageal Multichannel Intraluminal Impedance
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Effect of smectite as food thickener for treatment of gastroesophgeal reflux in neonates
研究概览
简要总结
study of diagnosis of GERD in neonates by MII-PH with trial of smectite for treatment
详细描述
This is a prospective clinical trial conducted on 20 preterm neonates < 37 weeks of gestation, admitted in NICU, maternity hospital, Ain Shams University. They were assessed for gastroesophageal reflux disease and investigated using ph-MII for detection of reflux episodes and they were given Smecta 3gm/day for 7 days at least as a food thickener and then ph-MII repeated to assess the response
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 0 Days 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Newborns free of any congenital anomalies or inborn errors of metabolism
- •Infants had signs of reflux like:
- •Typical or atypical crying and/or irritability
- •Apparent life-threatening event
- •Poor appetite; weight loss or poor growth (failure to thrive)
- •Bronchopulmonary dysplasia
- •Wheezing, stridor
- •Recurrent pneumonitis
- •Sandifer syndrome (ie, posturing with opisthotonus or torticollis)
排除标准
- •• Newborns with GIT anomalies as trans-esophageal fistula, hiatus hernia and other GIT anomalies causing reflux.
- •Patients with Hirshsprung disease or delayed passage of meconium.
- •History of NEC in the baby.
研究组 & 干预措施
Neonates before adding smectite
neonates will receive diosmectite for treating of gastroesophageal reflux in neonates after MII-ph
干预措施: Diosmectite (Drug)
neonates after adding smectite
neonates after they received diosmectite for treating of gastroesophageal reflux in neonates after MII-ph
干预措施: Diosmectite (Drug)
结局指标
主要结局
Effect of smectite as food thickener for treatment of gastroesophgeal reflux in neonates
时间窗: within 7 days
efficacy of Smectite as a food thickener in treating GERD in neonates using Multichannel intraluminal impedance-pH monitoring.
次要结局
- Reliability of signs for diagnosis of gastroesophageal reflux in neonates using MII-pH(within 24 hours)
研究者
Hend Fayez Ahmed
specialist
Ain Shams Maternity Hospital