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临床试验/NCT00970255
NCT00970255暂停不适用

Effect of Labial Frenulum Clipping on Nipple Pain and Latch Problems in Breastfeeding Infants

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年10月1日最近更新:
适应症
干预措施

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

Sham Comparator

干预措施: Sham frenotomy (Procedure)

Frenotomy

Active Comparator

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

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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