跳至主要内容
临床试验/NCT07750379
NCT07750379招募中不适用

Assessing the Role of Proton Pump Inhibitors in Reducing Aspiration Incidence in Pediatric Laryngomalacia Cases

Minia University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月28日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Participants receive PPI therapy in addition to vitamin D supplementation and feeding instructions.

干预措施: PPI (Drug)

PPI group

Experimental

Participants receive PPI therapy in addition to vitamin D supplementation and feeding instructions.

干预措施: feeding instruction (Behavioral)

standard group

Active Comparator

Participants receive vitamin D supplementation and feeding instructions only.

干预措施: feeding instruction (Behavioral)

PPI group

Experimental

Participants receive PPI therapy in addition to vitamin D supplementation and feeding instructions.

干预措施: vitamin D (Dietary Supplement)

standard group

Active Comparator

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

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Al shimaa Abd el monem

Assistant lecturer

Minia University

研究点 (1)

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