BreastfeedingPhase 2NCT04153513
Effect of Lanolin and Breastmilk in the Treatment of Sore and Damaged Nipples in Breastfeeding Women
A Phase 2 study testing Lanolin and Mother's milk in people with Breastfeeding, run by University of Mostar at 1 site in Bosnia and Herzegovina.
Trial summary
A randomized controlled study will be conducted at the accredited Baby Friendly Hospital in Mostar, Bosnia and Herzegovina. The study will include primiparas who have established breast feeding at the maternity ward and developed symptoms of painful and sore nipples within 72 hours from childbirth. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Lanolin and Mother's milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 1 Jan 2019to 30 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primiparas who have given birth to infants born at full term at between 37-41 weeks gestation
- Mothers complaint of nipple pain with any sign of nipple trauma to one or both nipples,
- Access to telephone
- Signed Informed consent
Who cannot join
- Primiparas with mental disorders
- Mothers allergy to lanolin
- Mothers with abnormal nipples
- Breast hypoplasia
- Infant with cleft palate
- Ankyloglossia
- Unsigned Informed consent
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
Department of Gynecology and Obstetrics, University Clinical Hospital Mostar
Mostar, HNŽ, 88000
About this study
Official title: Comparison of the Effect of Lanolin and Breastmilk in the Treatment of Sore and Damaged Nipples in Breastfeeding Women- a Randomized Controlled Trial
A randomized controlled study will be conducted at the accredited Baby Friendly Hospital in Mostar, Bosnia and Herzegovina. The study will include primiparas who have established breast feeding at the maternity ward and developed symptoms of painful and sore nipples within 72 hours from childbirth. Participants will be allocated in two groups and will receive education prior to the study.
Read the detailed description
Recent studies show that early termination of breastfeeding is often associated with painful and sore nipples. Although health professionals recommend various treatments for painful and sore nipples, including alternative treatments, there is currently not enough evidence to recommend specific treatment of painful and sore nipples in lactating women. The primary objective of this study is to compare the effect of lanolin administration and the application of breast milk on the intensity of pain and healing of damaged nipples during breastfeeding. Subjects in the lanolin group will apply lanolin on each nipple and areola after each feeding while subjects in the breast milk group will apply several drops of milk on the nipple after each feed and allow them to air dry. In both groups, the treatment will last for 7 days or until the symptoms of pain and nipple damage have ceased. The main outcome measure is pain, which will be assessed through three time points and will be measured using an abridged version of the McGill Pain Questionnaire. Nipple damage will be assessed by means of a validated assessment tool, the Nipple trauma score. Secondary outcome measures will include breastfeeding efficacy, duration of any/exclusive breastfeeding, reasons for stopping breastfeeding and satisfaction with proposed treatment.The contribution of this study will be reflected in efficient treatment, better care of health professional in the prevention and treatment of damaged and sore nipples, and the study will also contribute in defining the guidelines for the development of procedure in midwifery practice for the treatment of painful and damaged nipples.
- Conditions
- Breastfeeding
- Being tested
- Lanolin, Mother's milk
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LanolinDrug
Lanolin will be applied by hand in a thin layer to the nipple and areola after every breast feed (approximately every 2 to 3 hours) for a maximum of 7 days or until the symptoms of pain and signs of nipple damage have ceased (if noted before 7 days).
Mother's milkOther
After each breast feed (approximately every 2 to 3 hours), a few drops of breast milk will be applyed to the nipple and areola by hand and allow them to air dry. The treatment will last for up to 7 days or until the symptoms of pain and signs of nipple damage have ceased (if noted before 7 days).
| Study group | Role | What they receive |
|---|---|---|
| Lanolin | Experimental | Not described Receives: Drug: Lanolin |
| Mother's milk | Active comparator | Not described Receives: Other: Mother's milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nipple pain severity
An abbreviated version of the McGill Questionnaire (SF-MPQ) will be used to assess the intensity of nipple pain. For the assessment of the current intensity of pain in the nipples will be used subcategories SF-MPQ, the current assessment of pain (PPI). It consists of a verbal scoring scale with values from 0 to 5, 0= No pain, 1= Mild, 2 = Discomforting, 3= Distressing, 4= Horrible, 5= Excruciating
Measured: baseline, 3 and 7 days post randomization
Nipple damage change
The baseline assessment of nipple damage will be performed by a validated Nipple Trauma Score (NST). The assessment is performed on scales from 0 to 5 where 0 = no macroscopically visible changes in the skin, 1 = erythema or edema or a combination of both, 2 = superficial damage or no scab on <25% of the nipple surface, 3 = superficial damage with or without scab on> 25% of nipple surface, 4 = partial thickness wound with or without scab on <25% of nipple surface, 5 = partial thickness with or without scab on> 25% of nipple surface.
Three and 7 days after applying the treatment, the condition of the nipple will be evaluated with a Questionnaire on Pain and Damage to the Nipple, where a telephone survey will be performed by the Principal Investigator in order to describe and compare the condition of the nipples.
Measured: baseline, 3 and 7 days post randomization
Secondary outcomes (3)
Assessment of breastfeeding self-efficacy
Breastfeeding self-efficacy will be evaluated by a validated version of the Self-Efficacy Scale-Short Form (BSES-SF). The scale consists of 14 items, with the offered five statements on the Likert scale, from strongly disagree to strongly agree. The sum of grades ranges from 14 to 70, the higher the sum the greater the efficiency of breastfeeding.
Measured: baseline, 3 and 7 days post randomization
Breastfeeding duration and exclusivity.
The way of feeding of the baby in the last 24 hours will be evaluated by the World Health Organization (WHO) breastfeeding categories. The assessment will be conducted through a telephone interview with her mother.
Measured: 3 and 7 days post randomization, 3 and 6 months postpartum
Satisfaction with proposed treatment
The evaluation will be conducted by telephone interview with the Maternal Satisfaction
Measured: 3 and 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Jan 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mostar
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Hospital Centre Zagreb
- Responsible party
- Principal investigator, Olivera Perić, University of Mostar
- Investigators
- Olivera Perić, VII, Principal investigator, Department of Gynecology and Obstetrics, University Clinical Hospital MostarAnita Pavičić Bošnjak, VII, Study chair, Clinical Hospital Centre ZagrebVajdana Tomić, VII, Study chair, Department of Gynecology and Obstetrics, University Clinical Hospital Mostar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153513
- Sponsor's protocol ID
- Study 2
- Status last verified
- Feb 2021
- First submitted
- 26 Sep 2019
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Pavicic Bosnjak A, Rumboldt M, Stanojevic M, Dennis CL. Psychometric assessment of the croatian version of the breastfeeding self-efficacy scale-short form. J Hum Lact. 2012 Nov;28(4):565-9. doi: 10.1177/0890334412456240. Epub 2012 Sep 6.
PubMed 22956741Abou-Dakn M, Fluhr JW, Gensch M, Wockel A. Positive effect of HPA lanolin versus expressed breastmilk on painful and damaged nipples during lactation. Skin Pharmacol Physiol. 2011;24(1):27-35. doi: 10.1159/000318228. Epub 2010 Aug 18.
PubMed 20720454Peric O, Pavicic Bosnjak A, Mabic M, Tomic V. Comparison of Lanolin and Human Milk Treatment of Painful and Damaged Nipples: A Randomized Control Trial. J Hum Lact. 2023 May;39(2):236-244. doi: 10.1177/08903344221135793. Epub 2022 Nov 18.
PubMed 36401521
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Lanolin and Breastmilk in the Treatment of Sore and Damaged Nipples in Breastfeeding Women- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04153513
- Acronym / sponsor ID
- Study 2
- Conditions
- Breastfeeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University of MostarUniversity, hospital or other
- Collaborators
- Clinical Hospital Centre Zagreb
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled study will be conducted at the accredited Baby Friendly Hospital in Mostar, Bosnia and Herzegovina. The study will include primiparas who have established breast feeding at the maternity ward and developed symptoms of painful and sore nipples within 72 hours from childbirth. Participants will be allocated in two groups and will receive education prior to the study.
Detailed description
Recent studies show that early termination of breastfeeding is often associated with painful and sore nipples. Although health professionals recommend various treatments for painful and sore nipples, including alternative treatments, there is currently not enough evidence to recommend specific treatment of painful and sore nipples in lactating women. The primary objective of this study is to compare the effect of lanolin administration and the application of breast milk on the intensity of pain and healing of damaged nipples during breastfeeding. Subjects in the lanolin group will apply lanolin on each nipple and areola after each feeding while subjects in the breast milk group will apply several drops of milk on the nipple after each feed and allow them to air dry. In both groups, the treatment will last for 7 days or until the symptoms of pain and nipple damage have ceased. The main outcome measure is pain, which will be assessed through three time points and will be measured using an abridged version of the McGill Pain Questionnaire. Nipple damage will be assessed by means of a validated assessment tool, the Nipple trauma score. Secondary outcome measures will include breastfeeding efficacy, duration of any/exclusive breastfeeding, reasons for stopping breastfeeding and satisfaction with proposed treatment.The contribution of this study will be reflected in efficient treatment, better care of health professional in the prevention and treatment of damaged and sore nipples, and the study will also contribute in defining the guidelines for the development of procedure in midwifery practice for the treatment of painful and damaged nipples.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lanolin | Experimental | Drug: Lanolin |
| Mother's milk | Active comparator | Other: Mother's milk |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primiparas who have given birth to infants born at full term at between 37-41 weeks gestation
- Mothers complaint of nipple pain with any sign of nipple trauma to one or both nipples,
- Access to telephone
- Signed Informed consent
Key exclusion criteria (7 listed)
- Primiparas with mental disorders
- Mothers allergy to lanolin
- Mothers with abnormal nipples
- Breast hypoplasia
- Infant with cleft palate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LanolinLanolin will be applied by hand in a thin layer to the nipple and areola after every breast feed (approximately every 2 to 3 hours) for a maximum of 7 days or until the symptoms of pain and signs of nipple damage have ceased (if noted before 7 days). | Drug | Lanolin |
| Mother's milkAfter each breast feed (approximately every 2 to 3 hours), a few drops of breast milk will be applyed to the nipple and areola by hand and allow them to air dry. The treatment will last for up to 7 days or until the symptoms of pain and signs of nipple damage have ceased (if noted before 7 days). | Other | Mother's milk |
Primary outcome
Change in nipple pain severity
Time frame: baseline, 3 and 7 days post randomization
An abbreviated version of the McGill Questionnaire (SF-MPQ) will be used to assess the intensity of nipple pain. For the assessment of the current intensity of pain in the nipples will be used subcategories SF-MPQ, the current assessment of pain (PPI). It consists of a verbal scoring scale with values from 0 to 5, 0= No pain, 1= Mild, 2 = Discomforting, 3= Distressing, 4= Horrible, 5= Excruciating
Nipple damage change
Time frame: baseline, 3 and 7 days post randomization
The baseline assessment of nipple damage will be performed by a validated Nipple Trauma Score (NST). The assessment is performed on scales from 0 to 5 where 0 = no macroscopically visible changes in the skin, 1 = erythema or edema or a combination of both, 2 = superficial damage or no scab on <25% of the nipple surface, 3 = superficial damage with or without scab on> 25% of nipple surface, 4 = partial thickness wound with or without scab on <25% of nipple surface, 5 = partial thickness with or without scab on> 25% of nipple surface. Three and 7 days after applying the treatment, the condition of the nipple will be evaluated with a Questionnaire on Pain and Damage to the Nipple, where a telephone survey will be performed by the Principal Investigator in order to describe and compare the condition of the nipples.
3 secondary outcomes
Assessment of breastfeeding self-efficacy
Time frame: baseline, 3 and 7 days post randomization
Breastfeeding duration and exclusivity.
Time frame: 3 and 7 days post randomization, 3 and 6 months postpartum
Satisfaction with proposed treatment
Time frame: 3 and 6 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Results publication: PubMed 22956741Pavicic Bosnjak A, Rumboldt M, Stanojevic M, Dennis CL. Psychometric assessment of the croatian version of the breastfeeding self-efficacy scale-short form. J Hum Lact. 2012 Nov;28(4):565-9. doi: 10.1177/0890334412456240. Epub 2012 Sep 6.
- Results publication: PubMed 20720454Abou-Dakn M, Fluhr JW, Gensch M, Wockel A. Positive effect of HPA lanolin versus expressed breastmilk on painful and damaged nipples during lactation. Skin Pharmacol Physiol. 2011;24(1):27-35. doi: 10.1159/000318228. Epub 2010 Aug 18.
- Derived from this study: PubMed 36401521Peric O, Pavicic Bosnjak A, Mabic M, Tomic V. Comparison of Lanolin and Human Milk Treatment of Painful and Damaged Nipples: A Randomized Control Trial. J Hum Lact. 2023 May;39(2):236-244. doi: 10.1177/08903344221135793. Epub 2022 Nov 18.
- A Randomized Controlled Trial Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding WomenLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivera Perić, VII principal investigator
Department of Gynecology and Obstetrics, University Clinical Hospital Mostar
Anita Pavičić Bošnjak, VII study chair
Clinical Hospital Centre Zagreb
Vajdana Tomić, VII study chair
Department of Gynecology and Obstetrics, University Clinical Hospital Mostar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lanolin and Mother's milk in people with Breastfeeding, run by University of Mostar at 1 site in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nipple pain severity (time frame: baseline, 3 and 7 days post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04153513, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.