A Randomized Controlled Trial Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Nipple pain severity
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of lanolin for the treatment of painful/damaged nipples among breastfeeding women, and to evaluate if the use of lanolin has an effect on breastfeeding outcomes such as duration and exclusivity.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal complaint of nipple pain with any sign of nipple trauma to one or both nipples, such as blistering, crusting, redness, bleeding, swelling, cracking, discoloration or peeling.
- •Infant delivered at, or greater than 37 weeks gestation.
- •Singleton birth.
- •Speaks and understands English.
- •Access to telephone.
排除标准
- •Infant not expected to be discharged home with mother.
- •Infant with congenital abnormalities that would impair breastfeeding.
- •Maternal allergy to lanolin.
- •Maternal health conditions that may interfere with breastfeeding (physical or mental illness) as determined by hospital staff.
研究组 & 干预措施
Lanolin
Pea sized amount of lanolin to be applied to nipple and areola after every breast feed (approximately every 2-3 hours), until pain is completely resolved for a maximum of 7 days
干预措施: Lanolin (Other)
Standard postpartum nursing care
Women in standard care control group may receive any other nursing intervention to manage their nipple pain, including (but not limited to): recommending application of expressed breast milk, analgesics (such as acetaminophen or ibuprofen), breast shells, air drying, changing position / latch, cold or warm compresses
干预措施: Standard (usual) in-hospital and community postpartum care (Other)
结局指标
主要结局
Nipple pain severity
时间窗: 4 days post randomization
Measured with a 10-point numeric rating scale (NRS)
次要结局
- Breastfeeding duration(4 and 12 weeks postpartum)
- Breastfeeding exclusivity(4 and 12 weeks postpartum)
研究者
Cindy-Lee Dennis
Professor
University of Toronto