Effect of Labial Frenulum Clipping on Nipple Pain and Latch Problems in Breastfeeding Infants
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain score by Visual Analog Scale
研究概览
简要总结
Upper lingual frenulum have been implicated as a cause for pain during breastfeeding and latch problems. The investigators hypothesize that performing frenotomy of the frenulum may improve breastfeeding. The investigators will include breastfeeding infants with pain or latch problems in whom the lingual frenulum had been treated but breastfeeding problems were not resolved. The investigators plan to study the effect of frenotomy of the upper lingual frenulum on maternal pain (using pain score by visual analog scale) and/or latch score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •breastfeeding infants
- •maternal nipple pain
- •latching problems
排除标准
- •oral cavity anomalies
- •breast anatomical anomalies
- •untreated tongue-tie in infant
研究组 & 干预措施
Sham Frenotomy
干预措施: Sham frenotomy (Procedure)
Frenotomy
干预措施: Lingual Frenulum frenotomy (Procedure)
结局指标
主要结局
Pain score by Visual Analog Scale
时间窗: Within 30 minutes
Latch Score
时间窗: Within 30 Minutes
次要结局
未报告次要终点
