ANZCTR - Registration

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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 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]

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

Condition category

Condition code

Reproductive Health and Childbirth

Breast feeding

Inflammatory and Immune System

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]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Protein concentration in breastmilk (g/L)
Instrument: Bradford protein assay

Timepoint [1]

Immediately pre intervention and immediately post intervention

Secondary outcome [1]

Fat concentration was calculated in %
Instrument: The creamotocrit method

Timepoint [1]

Immediately pre intervention and immediately post intervention.

Secondary outcome [2]

Lactose concentration in breastmilk (g/L)
Instrument: enzymatic lactose assay

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Curtin University

Address [1]

Kent Street, Bentley, WA, 6102

Country [1]

Australia

Primary sponsor type

University

Name

Curtin University

Address

Curtin University. Kent Street, Bentley, WA, 6102

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics Committee

Ethics committee address [1]

Curtin University. Kent Street, Bentley, WA, 6102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/06/2021

Approval date [1]

10/08/2021

Ethics approval number [1]

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

Dr Leanda McKenna

Address

Curtin University. Kent street, Bentley, WA, 6102

Country

Australia

Phone

+61 8 92663660

Fax

l.mckenna@curtin.edu.au

Contact person for public queries

Name

Leanda McKenna

Address

Curtin University. Kent street, Bentley, WA, 6102

Country

Australia

Phone

+61 8 92663660

Fax

l.mckenna@curtin.edu.au

Contact person for scientific queries

Name

Leanda McKenna

Address

Curtin University. Kent street, Bentley, WA, 6102

Country

Australia

Phone

+61 8 92663660

Fax

l.mckenna@curtin.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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