Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000981123p
Ethics application status
Submitted, not yet approved
Date submitted
19/06/2019
Date registered
10/07/2019
Date last updated
15/11/2019
Date data sharing statement initially provided
10/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The LiTE Study - A study of Light therapy for nipple Trauma in Exclusively breastfeeding women
Scientific title
The LiTE Study - A study of Light therapy for nipple Trauma in Exclusively breastfeeding women
Secondary ID [1] 298506 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The LiTE study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nipple trauma 313300 0
Breastfeeding duration 313301 0
Quality of life 313302 0
Nipple pain 313303 0
Condition category
Condition code
Reproductive Health and Childbirth 311743 311743 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be conducted at the Mater Mothers' Private Hospital on the private inpatient maternity wards.

Participants with nipple trauma will be randomly allocated to Group A (standard care + red light therapy) or Group B (standard care + infrared light therapy). Standard care, as per Mater Policy, currently involves midwives and/or lactation consultants assisting with breastfeeding positioning and infant latching correction.

In addition to standard care, Group A and B will receive three sessions of light therapy which will be administered within 24 hours post group allocation. The light therapy treatments will be conducted by a qualified physiotherapist face to face in the study participants inpatient room on the postnatal wards. Both participant and therapist will wear safety glasses during the procedure to mitigate the risk of ocular damage if eye exposure to the LLLT incidentally occurs. A safety sign outside the participants room will be also be used to ensure no one else enters the room whilst performing the procedure.

A MID-LITE 6565 laser which contains two diodes will be used for group A with parameters being: continuous; wavelength 660nm; dose 4J/cm2. Three points over the nipple will be treated. The clock face method will be used to describe the treatment application. For the three applications, one diode will be placed directly over the centre of the nipple, with the second diode directing treatment at 12 o'clock, 4 o'clock and then 8 o'clock. Total application time per session will be 10 minutes.

A MID-LITE 904 infrared laser which contains three diodes will be used for Group B with settings adapted from Chaves et al., 2012 study as follows: continuous, wavelength 860nm; 50 mW power; dose 4J/cm2. The first application will involve positioning the first diode over the nipple with the other two diodes directed at 12 o'clock. The second application will be placed horizontally 2mm below the nipple on the breast, with the second diode placed directly underneath the nipple. Total application time per session will be 10 minutes.
Intervention code [1] 314758 0
Treatment: Devices
Comparator / control treatment
Group A is the comparator
Control group
Active

Outcomes
Primary outcome [1] 320430 0
Nipple pain will be evaluated using a Visual Analogue Scale (VAS) from 0-10
Timepoint [1] 320430 0
Nipple pain whilst breastfeeding will be assessed prior to treatment and after each subsequent light therapy application
Secondary outcome [1] 371565 0
Breastfeeding duration will be evaluated using a survey designed specifically for this study.
Timepoint [1] 371565 0
3 months post-partum
Secondary outcome [2] 371566 0
Quality of life will be assessed using the Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) questionnaire
Timepoint [2] 371566 0
Participants will be asked to complete the PROMIS-10 questionnaire at three time points being 1) prior to the first treatment 2)after the 3rd treatment and 3) 2 weeks post their first treatment date
Secondary outcome [3] 371567 0
Stakeholders acceptability of light therapy as an adjunctive treatment modality for nipple trauma will be assessed using a study-specific questionnaire
Timepoint [3] 371567 0
Post 3rd light therapy treatment

Eligibility
Key inclusion criteria
delivered through HATCH (private obstetrician cohort), nipple trauma, mother >18years old exclusively breastfeeding, infant rooming-in and spoken English to understand consent process, comprehend and participate in answering questionnaires.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
breast malignancy, diagnosed chronic illness such as persistent pain or psychological disorders, sensitivities to light

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/01/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14005 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 26784 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 303051 0
Hospital
Name [1] 303051 0
Mater Misericordiae Ltd
Country [1] 303051 0
Australia
Primary sponsor type
Hospital
Name
Mater Misericordiae Ltd
Address
Mater Misericordiae Ltd
Level 2 Aubigny Place
Raymond Terrace South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 303033 0
None
Name [1] 303033 0
Address [1] 303033 0
Country [1] 303033 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303603 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 303603 0
Human Research Ethics Committee, Mater Misericordiae Ltd,
Level 2 Aubigny Place, Raymond Terrace South Brisbane QLD 4101
Ethics committee country [1] 303603 0
Australia
Date submitted for ethics approval [1] 303603 0
15/07/2019
Approval date [1] 303603 0
Ethics approval number [1] 303603 0

Summary
Brief summary
The purpose of this study is determine which wavelength (red or infrared) LLLT is more effective for the management of nipple trauma. We also aim to determine stakeholder’s acceptability of the use of LLLT as an adjunctive treatment modality for nipple trauma.

Current guidelines recommend infants to be exclusively breastfed in the first 6 months of life to optimise their growth and development and minimise their risk of illnesses. Although most women are physiologically capable of breastfeeding, only 37% of infants worldwide are exclusively breastfeed for the first 6 months of life with nipple trauma being the second leading cause of early breastfeeding cessation.

Current research supports that warm water compresses, menthol and breastfeeding correction are effective treatments modalities for nipple pain. However, future studies regarding other interventions, including LLLT, are currently limited and require more robust studies to draw firm conclusions.

LLLT has been used to accelerate wound healing since its introduction in the 1960s. Although the exact mechanism of LLLT is not entirely understood, it is a phototherapy which has been shown to reduce pain and swelling and promote wound healing through cellular mechanisms. Typically, shorter wavelengths have more superficial penetration, where as longer wavelengths having more deeper penetration. Both red LLLT (660nm) and infrared LLLT (9040nm) have been studied, demonstrating promising effects on reducing nipple pain. However, no study has compared which wavelength is most effective in treating nipple trauma.

The current Mater Mothers work guideline is centred around midwife’s and/or lactation consultants correcting latching and breastfeeding positioning. LLLT would be an adjunctive to current standard care provided at the Mater. The results of this study will be utilised to guide the Mater Mothers work place guidelines for nipple trauma and nationwide.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94222 0
Ms Monique Bygott
Address 94222 0
Mater Mothers Hospital
20 Raymond Terrace
South Brisbane QLD 4101
Country 94222 0
Australia
Phone 94222 0
+61 7 3163 2920
Fax 94222 0
Email 94222 0
[email protected]
Contact person for public queries
Name 94223 0
Ms Monique Bygott
Address 94223 0
Mater Mothers Hospital
20 Raymond Terrace
South Brisbane QLD 4101
Country 94223 0
Australia
Phone 94223 0
+61 7 3163 8111
Fax 94223 0
Email 94223 0
[email protected]
Contact person for scientific queries
Name 94224 0
Ms Monique Bygott
Address 94224 0
Mater Mothers Hospital
20 Raymond Terrace
South Brisbane QLD 4101
Country 94224 0
Australia
Phone 94224 0
+61 7 3163 8111
Fax 94224 0
Email 94224 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Anyone who wishes to access the journal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Unrestricted access via publication


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.