Breastfeeding Improvement Following Tongue-tie and Lip-tie Release: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 237
- 主要终点
- Reflux/GERD
研究概览
简要总结
This study is an observational study to determine outcomes of surgical release of tongue-tie and lip-tie in babies who are experiencing difficulty with breastfeeding.
详细描述
Breastfeeding rates in the United States initiate at around 80%, but many mothers are unable to effectively breastfeeding because of problems with latch and suction generation. Previous studies have demonstrated how nipple pain is directly linked to ankyloglossia, but most of these studies are done with poor methodology.
Clinically, tongue-tie and lip-tie have correlate with numerous other symptoms besides nipple pain. These babies tend to be inefficient nursers, which can affect weight gain. Abnormal intake of air because of the poor latch/seal can lead to reflux symptoms. Finally, there is a significant psychological toll on mothers who want to breastfeed but cannot do so.
This study aims to prospectively analyze these outcomes by using validated tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy babies who are breastfeeding 0-12 weeks of age
排除标准
- •Serious comorbid conditions (heart, lung, brain)
- •Prior maternal breast surgery
- •Insufficient glandular tissue
- •Previous tongue/lip surgery
- •Twins/Triplets
结局指标
主要结局
Reflux/GERD
时间窗: 1 week
Using a validated questionnaire (i-GERQ-R)
Nipple Pain
时间窗: 1 week
Using a visual analog scale, nipple pain is evaluated.
Breastfeeding efficiency
时间窗: 1 week
Volume of breastmilk ingested in a specific time frame calculated (mL/min)
Breastfeeding self-efficacy
时间窗: 1 week
Uses the BSES-SF validated questionnaire
次要结局
- Reflux/GERD(1 month)
- Nipple Pain(1 month)
- Breastfeeding self-efficacy(1 month)
研究者
Bobak Ghaheri, MD
Otolaryngologist
The Oregon Clinic