Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women

Conditions
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Pain

Intervention / Treatment
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* Other: Lanolin
* Other: Standard (usual) in-hospital and community postpartum care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lanolin<br>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 | Other: Lanolin<br>* Pea-sized amount of lanolin applied to each nipple after every breastfeeding session (approximately 8-12 times daily) until complete resolution of nipple pain and damage for a maximum of 7 days.<br>|
| Other: Standard postpartum nursing care<br>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 | Other: Standard (usual) in-hospital and community postpartum care<br>* Women randomized to standard care will not receive lanolin or information regarding how to use lanolin. In-hospital standard care may include any of the following pain management measures at the recommendation / discretion of the participant's health care provider, or based on the patient's personal preference: analgesics (such as ibuprofen or acetaminophen); application of cold or warm compresses; application of ice packs; use of breast shields; air drying the nipples; or applying expressed breast milk.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nipple pain severity | Measured with a 10-point numeric rating scale (NRS) | 4 days post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding duration | Measured by asking women the last time their infant was breastfed. Breastfeeding duration will be calculated as the difference between the infant's date of birth, and the last day (date) the infant was breastfed. | 4 and 12 weeks postpartum | 
| Breastfeeding exclusivity | Measured with Labbok & Krasovek's framework for breastfeeding definition (Studies in Family Planning, 1990;21(4),226-230) | 4 and 12 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nipple pain, breastfeeding, nipple damage, lanolin, clinical trial