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临床试验/NCT06317688
NCT06317688Enrolling By Invitation1 期

Effectiveness of Highly Purified Anhydrous (HPA) Lanolin Versus Extra-Virgin Coconut Oil in Preventing Subacute Lactation Mastitis

Texas Woman's University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年11月6日最近更新:
适应症

试验速览

阶段
1 期
状态
Enrolling By Invitation
入组人数
100
试验地点
2
主要终点
Measurement of Development of Nipple Crack (Nipple Tenderness Scale Storr 1988)

研究概览

简要总结

Problem of the Study This study was designed to test the effectiveness of the application of extra-virgin coconut oil versus Highly Purified Anhydrous (HPA) Lanolin in ameliorating nipple pain, cracking and eventually the prevention of subacute lactation mastitis in breastfeeding women. It is theorized that the nipple crack, nipple pain are early warning signs of subacute clinical lactation mastitis. Goal is after application of extra-virgin coconut oil comparative analysis will be done at one week, three weeks, and six weeks. These complications associated with development of subacute mastitis can be addressed early during the first six weeks of lactation.

详细描述

Lanolin is the standard of care in many healthcare institutions. However, lanolin is not supported by the literature as a gold standard of treatment and care. Frequent dermatoses reactions as well as the lack of wound healing and its use as a protective barrier was not found sufficient to promote effective breastfeeding. The origin of lanolin as an animal by product is not ideal supplement for baby's first exposure to a supplement. Furthermore, there is lack of evidential support that lanolin can in fact promote wound healing.

Several studies have been conducted comparing lanolin to other treatments. A representative selection of these studies is presented here. A 2012 study of 100 breastfeeding women was conducted by Dennis et al., 2012, Lanolin was compared to an All-Purpose Nipple Ointment (combination of Mupirocin Ointment 2%, Betamethasone ointment 0.1%, Miconazole 2%) The researchers hypothesized that the combination of creams would target all the known causes of subacute clinical mastitis including fungal infection, atopic dermatitis reactions, staphylococcus aureus infections. The attention control in the double blinded randomized control trial was HPA purified Lanolin. Participants in both the lanolin group and the all-purpose nipple ointment group experienced severe dermal reactions from the topical application. It was concluded that both products were not effective for preventing complications during lactation but rather contributing to the complication of dermatoses.

Another study conducted by Niazi on a sample of 100 breastfeeding women tested the effects of Purslane cream with an attention control of Lanolin which is current practice and found that lanolin in fact doesn't possess wound healing properties but rather has protective barrier properties that are not necessarily intended for promotion of wound healing. Study participants in the purslane group had rapid repair of the nipple and were able to feed more frequently which maintained adequate milk supply and had a more fulfilling experience. Whereas the Lanolin group experiences less frequent feedings, more pain, and often decreased their duration of breastfeeding.

Jackson conducted a study in Ontario Canada of 186 breastfeeding women using a randomized control design to assess the effects of lanolin on nipple pain. No studies to date had assessed HPA Lanolin effects on nipple pain. Group assignment was randomized. An attention control group received latch education as an intervention while the experimental group used Lanolin on their breasts. Breastfeeding self-efficacy, pain rating and maternal satisfaction with lanolin was measured within the study. Lanolin was found to be no more effective than latch treatment group. The lanolin had short-term protective factors but did not promote wound healing. However, women in the study did report high satisfaction with the ease of use of HPA Lanolin.

Hildebrandt conducted a study of 50 postpartum women where the women were their own control nothing was applied to one nipple and HPA Lanolin was applied to the other. The women were monitored for 10 days postpartum, and they were asked to measure or report their pain twice a day using the nipple tenderness scale. The women in this study reported less nipple pain on the lanolin treated breast than on the breast that received no treatment. Similar to the study published by Jackson et al., (2017) Lanolin has some protective factors for short periods of time. Neither study went beyond 10 days of breastfeeding which makes it difficult to assess the long-term effects over the ideal breastfeeding time period.

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
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Given Birth and breastfeeding infant at least 50% of time

排除标准

  • Not breastfeeding

结局指标

主要结局

Measurement of Development of Nipple Crack (Nipple Tenderness Scale Storr 1988)

时间窗: Six weeks

Application should or is hypothesized to reduce the incidence of development of a nipple crack

Measurement of change in pain level (Numeric Pain Rating Scale McCaffery, 1989)

时间窗: Six weeks

The application should reduce the amount of pain at site

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sonia Riley

PhD Candidate

Texas Woman's University

研究点 (2)

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