The Impact of Lingual Frenotomy on Bottle Feeding Mechanics: a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Improved sucking parameter on the NFANT bottle feeding system - amplitude
研究概览
简要总结
Conservative estimates show that 3-5% of all infants have tongue tie. These studies only focus on visible, anterior tongue tie. Deeper, more visibly subtle cases of ankyloglossia have not been included in these incidence numbers, so the percentage of children with ankyloglossia is much higher than previously thought. Previous research by the investigators demonstrates that posterior tongue tie can be as problematic as anterior ties.
An available FDA-approved feeding solution allows for the measurement of infant sucking motions. This allows for detection of changes following surgical intervention. Previous ultrasound studies show the importance of the upward movement of the tongue, but further lingual movement parameters following frenotomy have not been reported.
The primary goal of this study is to record changes in lingual movement following lingual frenotomy. The investigators plan to compare improvements over time between a control, non-intervention group and a frenotomy group. Secondary goals include recording validated outcomes of reflux and feeding efficiency.
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
- 3 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Babies who are already fully or partially bottlefeeding
- •Have already worked with lactation consultant prior to appointment
- •Diagnosis of tongue tie
排除标准
- •Severe neurologic/cardiac/pulmonary comorbid diseases
- •Twins/Triplets
- •Other oral pathology (ie cleft lip/palate)
结局指标
主要结局
Improved sucking parameter on the NFANT bottle feeding system - amplitude
时间窗: 10 days
The NFANT bottle feeding system automatically generates measurements of sucking parameters. The first sucking parameter to be measured is calibrated nipple movement (amplitude)
Improved sucking parameter on the NFANT bottle feeding system - sucking duration
时间窗: 10 days
The NFANT bottle feeding system automatically generates measurements of sucking parameters. The second sucking parameter to be measured is sucking duration.
Improved sucking parameter on the NFANT bottle feeding system - sucking frequency
时间窗: 10 days
The NFANT bottle feeding system automatically generates measurements of sucking parameters. The second sucking parameter to be measured is sucking frequency.
Improved sucking parameter on the NFANT bottle feeding system - sucking smoothness
时间窗: 10 days
The NFANT bottle feeding system automatically generates measurements of sucking parameters. The second sucking parameter to be measured is sucking smoothness.
次要结局
- Measurement of infant reflux(10 days)
- Measurement of feeding efficiency(10 days)
研究者
Bobak Ghaheri, MD
Otolaryngologist
The Oregon Clinic