Assessing the Role of Proton Pump Inhibitors in Reducing Aspiration Incidence in Pediatric Laryngomalacia Cases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of aspiration
研究概览
简要总结
Laryngomalacia is the most common congenital laryngeal anomaly in children and is frequently associated with aspiration. This randomized controlled study aims to assess the role of proton pump inhibitor (PPI) therapy in reducing the incidence of aspiration in pediatric patients with laryngomalacia. Eligible participants will be randomly assigned to either a PPI treatment group or a control group. Clinical and swallowing assessments will be performed to compare aspiration incidence and swallowing outcomes between the two groups
详细描述
Laryngomalacia is the most common congenital laryngeal anomaly in infants and is frequently associated with feeding difficulties and aspiration. Gastroesophageal reflux has been suggested to contribute to symptom severity and aspiration in these patients. Although proton pump inhibitors (PPIs) are commonly prescribed, evidence regarding their effectiveness in reducing aspiration is still limited.
This randomized controlled trial aims to evaluate the role of PPI therapy in reducing the incidence of aspiration in pediatric patients with laryngomalacia. Eligible participants will be randomly assigned to either an intervention group receiving PPI therapy in addition to standard care or a control group receiving standard care alone. Standard care will include vitamin D supplementation and feeding instructions for all participants. Clinical evaluation and swallowing assessment will be performed at baseline and during follow-up. The incidence of aspiration and swallowing outcomes will be compared between the two groups to determine the effectiveness of adding PPI therapy to standard management. The results of this study may provide evidence to optimize the management of pediatric laryngomalacia and reduce aspiration-related complications.
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
盲法说明
This is an open-label study. Participants, caregivers, investigators, and outcome assessors are aware of the assigned intervention
入排标准
- 年龄范围
- 6 Months 至 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed with laryngomalacia by laryngoscopic examination with a history of recurrent choking attacks or aspiration symptoms.
- •Children aged from 6 months to 5 years.
排除标准
- •Children with any neurological impairment.
- •Children with other congenital anomalies.
- •Children with other causes of respiratory distress
研究组 & 干预措施
PPI group
Participants receive PPI therapy in addition to vitamin D supplementation and feeding instructions.
干预措施: PPI (Drug)
PPI group
Participants receive PPI therapy in addition to vitamin D supplementation and feeding instructions.
干预措施: feeding instruction (Behavioral)
standard group
Participants receive vitamin D supplementation and feeding instructions only.
干预措施: feeding instruction (Behavioral)
PPI group
Participants receive PPI therapy in addition to vitamin D supplementation and feeding instructions.
干预措施: vitamin D (Dietary Supplement)
standard group
Participants receive vitamin D supplementation and feeding instructions only.
干预措施: vitamin D (Dietary Supplement)
结局指标
主要结局
Incidence of aspiration
时间窗: 2months
comparison of the incidence of aspiration between the PPI group and the standard group
次要结局
未报告次要终点
研究者
Al shimaa Abd el monem
Assistant lecturer
Minia University
