Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001025820
Ethics application status
Approved
Date submitted
25/06/2021
Date registered
5/08/2021
Date last updated
15/02/2022
Date data sharing statement initially provided
5/08/2021
Date results information initially provided
15/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Therapeutic Ultrasound on Breastmilk Composition
Scientific title
Effects of therapeutic ultrasound on breastmilk composition of mothers who are 1-6 months post partum and exclusively breastfeeding
Secondary ID [1] 304628 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory conditions of the lactating breast 322560 0
Condition category
Condition code
Reproductive Health and Childbirth 320180 320180 0 0
Breast feeding
Inflammatory and Immune System 320447 320447 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Therapeutic ultrasound:
Therapeutic ultrasound (Chattanooga, model: Intelect Advanced 2772MC, Austin, Texas, USA) will delivered by one of the researchers using a 5cm2 soundhead, with consistent, light pressured, overlapping and linear strokes for 10 minutes. It will be delivered closely adjacent to the nipple from a superolateral to inferomedial direction. Continuous ultrasound at 1MHz will be utilised and the median of the clinically used intensity within Australia of 1.8Wcm2 will be tested. The frequency of ultrasound therapy will be a single session only. The intervention session will be of approximately 30 minutes duration, consisting of the provision of 2 milk samples (pre and post ultrasound therapy) and a singular, 10 minute session of therapeutic ultrasound. Monitoring of adherence will not be required, as it is single session only.
Mothers interested in participating in the study will be screened for eligibility via a Qualtrics survey sent by email which will contain a link to the participation information document detailing the research and their potential role and informed consent will be gained. Data collection will occur in an enclosed room within a church building in Kewdale, Western Australia (WA).
A qualified physiotherapist, who has undergone undergraduate training in this modality and has had many hours of clinical experience using therapeutic ultrasound as a treatment modality, will deliver it to all participants.
Intervention code [1] 320979 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328063 0
Protein concentration in breastmilk (g/L)
Instrument: Bradford protein assay
Timepoint [1] 328063 0
Immediately pre intervention and immediately post intervention
Secondary outcome [1] 397404 0
Fat concentration was calculated in %
Instrument: The creamotocrit method
Timepoint [1] 397404 0
Immediately pre intervention and immediately post intervention.
Secondary outcome [2] 397405 0
Lactose concentration in breastmilk (g/L)
Instrument: enzymatic lactose assay
Timepoint [2] 397405 0
Immediately pre intervention and immediately post intervention.

Eligibility
Key inclusion criteria
English-speaking mothers aged over 18 whose infants are aged between 1-6 months, who are fully breastfeeding (i.e. not pumping more than twice a day).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Mothers who are mixed feeding (i.e. with formula or solids) or have a history and/or current inflammatory condition of the lactating breast will be excluded. Women who have a current pregnancy; known or suspected cancer; circulation problems; bleeding disorders; acute infection; disease of the nervous system; heart condition or cardiac pacemaker and any other electronic, metallic or breast implants will be excluded as they will be ineligible to receive therapeutic ultrasound.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Power calculations were based on the primary outcome measure of breast milk protein concentration. Additionally, in comparison to lactose or fat, protein is more likely to be impacted by TUS due to denaturing of proteins. For a within factors repeated measures ANOVA, n=22 was required to detect an effect size f=0.35 (equivalent to a partial eta-squared of 0.11, based on a 10% change in protein from a mean of 12.6g/L with pooled SD = 1.8) within a single group over 2 timepoints (pre-post), with alpha=0.025 as per a non-inferiority study. Based on a 10% contingency, a sample of n=25 was estimated.

Generalised linear mixed models were used to analyse pre-post differences in breastmilk composition, after adjusting for lactation stage as determined by age of the baby and time since last feed from the right breast in minutes. Results were summarised using marginal means and 95% confidence intervals. Statistical analysis was completed using Stata I/C v16.0 (StataCorp, College Station, TX).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/08/2021
Actual
11/08/2021
Date of last participant enrolment
Anticipated
Actual
25/10/2021
Date of last data collection
Anticipated
Actual
28/10/2021
Sample size
Target
25
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 308989 0
University
Name [1] 308989 0
Curtin University
Country [1] 308989 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University. Kent Street, Bentley, WA, 6102
Country
Australia
Secondary sponsor category [1] 309926 0
None
Name [1] 309926 0
Address [1] 309926 0
Country [1] 309926 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308882 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 308882 0
Curtin University. Kent Street, Bentley, WA, 6102
Ethics committee country [1] 308882 0
Australia
Date submitted for ethics approval [1] 308882 0
24/06/2021
Approval date [1] 308882 0
10/08/2021
Ethics approval number [1] 308882 0
HRE2021-0469

Summary
Brief summary
Inflammatory conditions of the lactating breast (ICLB) can affect up to 33% of breastfeeding mothers in the early post-partum period and are associated with pain, redness, flu-like symptoms, and fever. Physiotherapy intervention has an important role in the treatment of ICLB, which most commonly includes therapeutic ultrasound (TUS). TUS can produce heat and other non-thermal effects through sound wave energy which may assist in resolution of ICLB by reducing inflammation, accelerating tissue healing, clearing blocked ducts and other antimicrobial properties. Breastmilk contains numerous important components that combine to create the optimal nutritional source for infants. The most abundant of these components include water (87%), lactose (7%), fat (4%) and protein (1%). As TUS generates heat in the lactating breast, there is concern from Physiotherapists providing TUS and the mothers receiving it, that breastmilk composition may be affected.

This is a quasi-experimental study with pre-post measures taken in a single session. Mothers will provide hand expressed breast milk samples pre and post application of continuous therapeutic ultrasound at 1MHz and at the highest clinically used intensity within Australia of 2.2Wcm2. Protein (g/L), lactose (g/L) and fat (g/L) concentrations will be analysed from the milk samples collected before and after TUS.

The primary hypothesis of this study is that protein, lactose and fat concentrations within breastmilk will not change significantly before and after the application of TUS to the breast.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112202 0
Dr Leanda McKenna
Address 112202 0
Curtin University. Kent street, Bentley, WA, 6102
Country 112202 0
Australia
Phone 112202 0
+61 8 92663660
Fax 112202 0
Email 112202 0
l.mckenna@curtin.edu.au
Contact person for public queries
Name 112203 0
Leanda McKenna
Address 112203 0
Curtin University. Kent street, Bentley, WA, 6102
Country 112203 0
Australia
Phone 112203 0
+61 8 92663660
Fax 112203 0
Email 112203 0
l.mckenna@curtin.edu.au
Contact person for scientific queries
Name 112204 0
Leanda McKenna
Address 112204 0
Curtin University. Kent street, Bentley, WA, 6102
Country 112204 0
Australia
Phone 112204 0
+61 8 92663660
Fax 112204 0
Email 112204 0
l.mckenna@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Other filesNo 382286-(Uploaded-10-02-2022-00-27-31)-Other results publication.pdf
Plain language summaryNo The research question was whether therapeutic ultr... [More Details]

Documents added automatically
No additional documents have been identified.