Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women

NCT01420419 | Completed Phase 4

• 1 other identifier: 26044
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

nipple pain; breastfeeding; nipple damage; lanolin; clinical trial

Outcome Measures

Primary Outcomes (1)

• Nipple pain severity

  Measured with a 10-point numeric rating scale (NRS)

  4 days post randomization

Secondary Outcomes (2)

• Breastfeeding duration

  4 and 12 weeks postpartum

• Breastfeeding exclusivity

  4 and 12 weeks postpartum

Study Arms (2)

Lanolin

EXPERIMENTAL

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

Standard postpartum nursing care

OTHER

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

Interventions

Lanolin OTHER

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.

Lanolin

Standard (usual) in-hospital and community postpartum care OTHER

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.

Standard postpartum nursing care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Postpartum Unit St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Pain; Breast Feeding

Interventions

Lanolin; Hospitals

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Waxes; Lipids; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Cindy-Lee Dennis, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: August 19, 2011
• Study Start: May 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

CA (1)