Comparison of Different Feeding Appliances for Cleft Palate Babies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The feeding efficiency
研究概览
简要总结
This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.
详细描述
This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.
The purpose of the present study will be explained to the patient's parents and informed consent will be obtained according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.
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
入排标准
- 年龄范围
- 1 Day 至 15 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants with age range from 1-15 days.
- •Unilateral cleft palate.
- •Medically free subjects.
- •Both males and females.
排除标准
- •Patients older than 15 days.
- •Syndromic patients with other defects in addition to cleft lip and palate.
- •Patients with bilateral cleft lip and palate.
- •Patients with previous presurgical infant orthopedic treatment.
- •Medically compromised patients.-
研究组 & 干预措施
group 1 rigid feeding plate
Heat cure polymerizing acrylic resin was used to fabricate the second appliance.
干预措施: flexible feeding plate (Device)
group 2 flexible feeding plate
One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine.
干预措施: flexible feeding plate (Device)
special feeding appliance
special feeding bottle
干预措施: flexible feeding plate (Device)
结局指标
主要结局
The feeding efficiency
时间窗: during 1 month
The measure was defined as the volume of fluid transferred per unit time, in milliliters per minute (mL/min).
次要结局
未报告次要终点
研究者
Amel Salem
Clinical professor
Tanta University