Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women (LanP)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: Lanolin; Other: Standard (usual) in-hospital and community postpartum care

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • Postpartum Unit St. Joseph's Healthcare Hamilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Other: Lanolin; 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.
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	Other: Standard (usual) in-hospital and community postpartum care; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Toronto
• Investigators: Principal Investigator: Cindy-Lee Dennis, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: March 29, 2011
• First Submitted That Met QC Criteria: August 18, 2011
• First Posted (ESTIMATE): August 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 16, 2013
• Last Update Submitted That Met QC Criteria: January 14, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: clinical trial; breastfeeding; nipple pain; nipple damage; lanolin
• Other Study ID Numbers: 26044