Efficacy of Neonatal Release of Ankyloglossia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Maternal nipple pain as judged by R. Melzack's short form pain scale and infant breast feeding as judged by IBFAT scale
研究概览
简要总结
The purpose of this study is to determine if frenotomy for ankyloglossia will improve infant breastfeeding, decrease maternal nipple pain and increase duration of breastfeeding with the hypothesis that frenotomy will do all of the above.
详细描述
The primary objective of our study is to determine if frenotomy (or release of tongue tie) for ankyloglossia (tongue tie) will decrease maternal nipple pain with breast feeding and improve infant's ability to breast feed. Our secondary objective is to determine if frenotomy for ankyloglossia will improve the length of time a mother breast feeds. Our hypothesis is that frenotomy will decrease maternal nipple pain, improve infant's breast feeding and prolong the duration of breast feeding.
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
- Single
入排标准
- 年龄范围
- 0 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Significant ankyloglossia as judged by Hazelbaker scale (HATLFF)
- •Report of maternal nipple pain with feeding
- •Report of difficulty with infant breast feeding
排除标准
- •Significant craniofacial defects
- •Age >14 days at enrollment
- •Any maternal contraindication to breastfeeding
- •Neurologic defects that would impair breast feeding
结局指标
主要结局
Maternal nipple pain as judged by R. Melzack's short form pain scale and infant breast feeding as judged by IBFAT scale
时间窗: immediately following 1st breast feed, and at 2 week, 2,4,6 12 month follow ups
次要结局
- Length of breast feeding(1 year follow up)