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Trial registered on ANZCTR


Registration number
ACTRN12625000006448
Ethics application status
Approved
Date submitted
7/10/2024
Date registered
7/01/2025
Date last updated
7/01/2025
Date data sharing statement initially provided
7/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Breastfeeding Osteopathic Manual Therapy Study - two-armed, multi-centre, pragmatic, randomised clinical trial, pilot and trial.
Scientific title
Effect of Breastfeeding osteopathic manual therapy on bristol breastfeeding assessment scores and breastfeeding self efficacy: The Breastfeeding Osteopathic Manual Therapy Study
Secondary ID [1] 313139 0
Nil
Universal Trial Number (UTN)
Trial acronym
BOMTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breastfeeding Difficulty 335395 0
Condition category
Condition code
Reproductive Health and Childbirth 331966 331966 0 0
Breast feeding
Diet and Nutrition 332542 332542 0 0
Other diet and nutrition disorders
Physical Medicine / Rehabilitation 332543 332543 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The preliminary stage will pilot the design at a single clinic in Melbourne by recruiting 16 mother-infant-dyads (MIDs) experiencing breastfeeding difficulty. The participants in the pilot study will be included in the full RCT. The full stage will continue the pilot stage and see a further 54 MIDs (total N=70) experiencing breastfeeding difficulty randomly allocated to the same two groups. Recruitment for this stage will be from osteopathic clinics, maternal health centres and breastfeeding drop-in centres across metropolitan Melbourne and Canberra. The protocol and procedures will remain the same in the pilot RCT, there is an internal analysis and safety review between the pilot and the full RCT.

Each participant will undergo 4 weeks of intervention with a follow-up phone call one-month post-intervention. All participants will receive a maximum of two IBCLC face-to-face sessions and two IBCLC telehealth calls over a 4-week period. In addition to this, the IBCLC group will receive up to two additional telehealth consultations if required whereas the IBCLC + OMT group will receive up to three face to face OMT consultations.

Additional consultations will be determined by the consulting practitioner based on needs of the individual dyads.

Intervention Components:

International Board-Certified Lactation Consultation (IBCLC) - Registered IBCLC to provide all IBCLC consultations.

Consultations with the IBCLC will include:
Breastfeeding assessment
Education
Latch and positioning techniques
Advice on pumping and expressing milk
Breastfeeding and nutritional counselling
Growth and development monitoring
Emotional support, counselling and problem solving
Measurement of weight, length, and head circumference to track growth
Assessment of vital signs, including heart rate, respiratory rate, and temperature

Osteopathic Manual Therapy - provided by an Osteopath with 10 years clinical experience treating infants with breastfeeding difficulties.

Consultations with the Osteopath will include:
Medical history taking, including pregnancy, birth and infant medical history
Postural education for both mother and baby during feeding, breastfeeding assessment, latch and suck function
Positioning assessment
Musculoskeletal and health screen of infants including assessment of musculoskeletal trauma or birth trauma, plagiocephaly or torticollis
Monitoring of developmental milestones and cognitive development.
Sleep habit and sleep safety assessment
Head preference and infant positioning assessment,
Crying habit assessment
Osteopathic Paediatric Physical Examination: Includes the following
Examination of the skin, eyes, ears, nose, tongue, palate and throat
Inspection of the abdomen for any abnormalities or signs of discomfort
Evaluation of muscle tone and primitive reflexes and established reflexes
Examination of the spine, pelvis, hips and peripheral joints
Examination of facial, jaw and cranial asymmetry
Examination of infant suck function
Gentle Osteopathic Techniques for infant musculoskeletal care may include
Cranial Osteopathy
Paediatric osteopaths may use gentle manual techniques to assess and address any restrictions or imbalances in the infant's musculoskeletal system, including the cranium, face, jaw, cervical spine and associated musculoskeletal structures.

Oral assessment and suck function:
Paediatric osteopaths may assess the oral anatomy, structure and function, palate shape, buccal and oral muscular tone, as well as infant suck function. This often includes assessment of tethered oral tissues that may be inhibiting infant suck function. Treatment may involve gentle techniques to release tension in the affected area as well as referral to a general practitioner or paediatrician for ankyloglossia assessment and medically guided management

Myofascial Release: Paediatric osteopaths may use myofascial release techniques to address tension in the muscles and connective tissues around the baby's mouth, face, and neck. This can be especially relevant for babies experiencing difficulty latching or sucking effectively.

Overal duration

It is anticipated that the recruitment phase of the trial will be 12 months. If the target recruitment number is not reached in that time, there is provision to extend the recruitment period by a further 6 months. The entire project will run over a 2-year period.. Each participant will be involved for a total of 8 weeks.

INTERVENTION
Week 0. Baseline Measurements (control and intervention groups) - 60 minutes
Week 1. IBCLC consultation (control and intervention groups) - 60 minutes
Week 2. IBCLC consultation (control and intervention groups) - 30 minutes
OMT (intervention group only) - 60 minutes
Week 3. Up to 2 x 1/2-hour IBCLC Telehealth (control group) - 60 minutes
Up to 2 x ¼ - hour IBCLC telehealth (Intervention group - 30 minutes
OMT (intervention group only) - 30 minutes
Week 4. Up to 2 x 1/2 - hour IBCLC Telehealth (as required) - 60
OMT 3 (as required) (Intervention group) -30 minutes
Post Intervention paperwork (Online) (control and intervention groups) - 30 minutes
Week 8. Discharge paperwork - Follow up Phone call. (control and intervention groups) - 30 minutes

The mother will not recieve osteopathic care - only the infant.

Strategies to monitor adherence to the intervention: IBCLC and Osteopathic session are recorded, including medical history and care provided, This occures with every session of the trail. Follow up telehealth calls from the IBCLC also help to monitor adherance.

Intervention code [1] 329710 0
Treatment: Other
Comparator / control treatment
The control group recieved lactation care only.

Lactation care is provided by the IBCLC

Each participant will undergo 4 weeks of intervention with a follow-up phone call one-month post-intervention. All participants will receive a maximum of two IBCLC face-to-face sessions and two IBCLC telehealth calls over a 4-week period.

INTERVENTION IBCLC (Minutes)
Week 0 Baseline Measurements - 60 minutes
Week 1 IBCLC - 60 minutes
Week 2. IBCLC - 30 minutes
Week 3. Up to 2 x 1/2-hour IBCLC Telehealth - 60 minutes
Week 4. Up to 2 x 1/2 - hour IBCLC Telehealth (as required) 60 minutes
Post Intervention paperwork (Online) 30 minutes
Week 8. Discharge paperwork - Follow up Phone call 30 minutes

Additional (as required) consultations will be determined by the treating practitioner based on individual dyad needs.
Control group
Active

Outcomes
Primary outcome [1] 339578 0
Breastfeeding
Timepoint [1] 339578 0
Baseline - prior to intervention commencement
Week 4 - post intervention commencement
Primary outcome [2] 339579 0
Breastfeeding Self-Efficacy - How a mohter precieves her breastfeeding
Timepoint [2] 339579 0
Base Line - prior to intervention commencement (Primary start point)
Week 4 - post intervention commencement (Primary end point)
Week 8 - one month post intervention commencement (secondary end point)
Secondary outcome [1] 440489 0
Pain while breastfeeding
Timepoint [1] 440489 0
Base Line - prior to intervention commencement
Week 4 - post intervention commencement
Week 8 - one month post intervention commencement
Secondary outcome [2] 440490 0
Ability to latch to the breast
Timepoint [2] 440490 0
Base Line - prior to intervention commencement
Week 4 - post intervention commencement
Week 8 - one month post intervention commencement
Secondary outcome [3] 440491 0
ABility to maintain latch to the breast
Timepoint [3] 440491 0
Base Line - prior to intervention commencement
Week 4 - post intervention commencement
Week 8 - one month post intervention commencement
Secondary outcome [4] 440492 0
Noise made while feeding
Timepoint [4] 440492 0
Base Line - prior to intervention commencement
Week 4 - post intervention commencement
Week 8 - one month post intervention commencement

Eligibility
Key inclusion criteria
Mother must have read the information sheet and signed the consent form.
MID must have an intake BBAT score of <5
Mother must be 18 years of age or older, maximum age 60 years old
In order to provide informed consent, the mother requires a certain level of proficiency in English. If she is not sufficiently proficient in English, the mother can use the Federal Government’s Telephone Interpreter Service. Alternatively, the mother can provide her own support person to help with translation.
Mother must self-identify as having difficulty breastfeeding
Mother must be breastfeeding, attempting to breastfeed, or wishing to re-establish breastfeeding
Infant must be < 6 months of age at the time of enrolment
Infant gestation at birth must be > 37 weeks
Minimum age
1 Days
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infant > 6 months of age at the time of enrolment
Mother not breastfeeding and does not intend to initiate or reinstate breastfeeding
Infant has a congenital condition that impacts breastfeeding e.g. cleft palate
Mother requires medication that is contraindicated for breastfeeding
Infant is part of a twin or multiple birth

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)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence
generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
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
1/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC

Funding & Sponsors
Funding source category [1] 317581 0
Commercial sector/Industry
Name [1] 317581 0
Osteopathy Australia
Country [1] 317581 0
Australia
Funding source category [2] 317582 0
Charities/Societies/Foundations
Name [2] 317582 0
Southerland Cranial Teaching Foundation AUS & NZ
Country [2] 317582 0
Australia
Funding source category [3] 317583 0
Other Collaborative groups
Name [3] 317583 0
ARCOM - Austrlain Research Council Osteoapthic Medicine
Country [3] 317583 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Osteopathy Australia
Address
Country
Australia
Secondary sponsor category [1] 319887 0
Charities/Societies/Foundations
Name [1] 319887 0
Southerland Cranial Teaching FOundation AUS/NZ
Address [1] 319887 0
Country [1] 319887 0
Australia
Secondary sponsor category [2] 319888 0
Charities/Societies/Foundations
Name [2] 319888 0
Australian Research Council Osteoapthic Medicine
Address [2] 319888 0
Country [2] 319888 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316288 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 316288 0
https://www.scu.edu.au/research/research-excellence/research-ethics/
Ethics committee country [1] 316288 0
Australia
Date submitted for ethics approval [1] 316288 0
20/11/2023
Approval date [1] 316288 0
20/06/2024
Ethics approval number [1] 316288 0
2024/082

Summary
Brief summary
This study is a two-armed, multi-centre, pragmatic, randomised clinical trial designed to examine the effect of osteopathic care (OMT) on breastfeeding dyads experiencing breastfeeding difficulty. The trial will be conducted in two stages: preliminary and full. Both stages have the same design.
The preliminary stage will pilot the design at a single clinic in Melbourne by recruiting 16 mother-infant-dyads (MIDs) experiencing breastfeeding difficulty. The full stage will extend the pilot to multiple clinics across VIC, TAS, ACT, NSW and QLD.
Participants in both stages will be randomly allocated to one of two groups: international board-certified lactation consultant (IBCLC) - Standard care (Control) or IBCLC plus osteopathic intervention (OMT) (Experimental). The full stage will continue the pilot stage and see a further 54 MIDs (total N=70) experiencing breastfeeding difficulty randomly allocated to the same two groups. Recruitment for this stage will be from osteopathic clinics, maternal health centres and breastfeeding drop-in centres across metropolitan Melbourne and Canberra.
Each participant will undergo 4 weeks of intervention with a follow-up phone call one-month post-intervention.
The primary outcome of the study is change in infant breastfeeding function as measured by the Bristol Breastfeeding Assessment Tool (BBAT).
Secondary outcomes include maternal breastfeeding confidence, as measured by the Breastfeeding Self-efficacy Scale – Short from (BSES-SF) and changes in breastfeeding symptoms such as maternal breastfeeding-related pain, infant ability to latch and maintain latch to the breast and feeding noise at the breast measured using a series of visual analogue scales (VAS).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137406 0
Mrs Kirsty Greenwood
Address 137406 0
Southern Cross University, Military Rd, East Lismore NSW 2480
Country 137406 0
Australia
Phone 137406 0
+61 0400443463
Fax 137406 0
Email 137406 0
[email protected]
Contact person for public queries
Name 137407 0
Kirsty Greenwood
Address 137407 0
Southern Cross University, Military Rd, East Lismore NSW 2480
Country 137407 0
Australia
Phone 137407 0
+61 0400443463
Fax 137407 0
Email 137407 0
[email protected]
Contact person for scientific queries
Name 137408 0
Kirsty Greenwood
Address 137408 0
Southern Cross University, Military Rd, East Lismore NSW 2480
Country 137408 0
Australia
Phone 137408 0
+61 0400443463
Fax 137408 0
Email 137408 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24245Study protocol    388587-(Uploaded-07-10-2024-16-52-42)-PROTOCOL.pdf
24246Ethical approval    388587-(Uploaded-07-10-2024-16-53-06)-Approval notification.pdf
24247Informed consent form    388587-(Uploaded-07-10-2024-16-54-10)-PARTICIPANT CONSENT FORM FINAL.docx
24248Informed consent form    388587-(Uploaded-07-10-2024-16-54-10)-PRACTITIONER CONSENT FORM.docx



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.