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DEFINITIONS
Trial Review
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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.
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Scientific title
Effect of Breastfeeding osteopathic manual therapy on bristol breastfeeding assessment scores and breastfeeding self efficacy: The Breastfeeding Osteopathic Manual Therapy Study
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Secondary ID [1]
313139
0
Nil
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Universal Trial Number (UTN)
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Trial acronym
BOMTS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breastfeeding Difficulty
335395
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Condition category
Condition code
Diet and Nutrition
332542
332542
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0
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Other diet and nutrition disorders
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Physical Medicine / Rehabilitation
332543
332543
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0
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Other physical medicine / rehabilitation
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Reproductive Health and Childbirth
331966
331966
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0
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Breast feeding
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329710
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Breastfeeding Self-Efficacy - How a mohter precieves her breastfeeding
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Assessment method [1]
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Brestfeeding Self-Efficacy Score - Short Form
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Timepoint [1]
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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)
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Primary outcome [2]
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Breastfeeding
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Assessment method [2]
339578
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Bristol Breatfeeding Assesment Tool
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Timepoint [2]
339578
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Baseline - prior to intervention commencement Week 4 - post intervention commencement
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Secondary outcome [1]
440491
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ABility to maintain latch to the breast
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Assessment method [1]
440491
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Visual Analogue Scale
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Timepoint [1]
440491
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Base Line - prior to intervention commencement Week 4 - post intervention commencement Week 8 - one month post intervention commencement
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Secondary outcome [2]
440492
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Noise made while feeding
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Assessment method [2]
440492
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Visual Analogue Scale
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Timepoint [2]
440492
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Base Line - prior to intervention commencement Week 4 - post intervention commencement Week 8 - one month post intervention commencement
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Secondary outcome [3]
440489
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Pain while breastfeeding
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Assessment method [3]
440489
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Visual Anaoogue Scale
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Timepoint [3]
440489
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Base Line - prior to intervention commencement Week 4 - post intervention commencement Week 8 - one month post intervention commencement
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Secondary outcome [4]
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Ability to latch to the breast
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Assessment method [4]
440490
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Visual Analogue Scale
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Timepoint [4]
440490
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Base Line - prior to intervention commencement Week 4 - post intervention commencement Week 8 - one month post intervention commencement
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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
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Minimum age
1
Days
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence
generation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/02/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
70
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC
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Funding & Sponsors
Funding source category [1]
317583
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Other Collaborative groups
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Name [1]
317583
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ARCOM - Austrlain Research Council Osteoapthic Medicine
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Address [1]
317583
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Country [1]
317583
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Australia
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Funding source category [2]
317582
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Charities/Societies/Foundations
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Name [2]
317582
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Southerland Cranial Teaching Foundation AUS & NZ
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Address [2]
317582
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Country [2]
317582
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Australia
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Funding source category [3]
317581
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Commercial sector/Industry
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Name [3]
317581
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Osteopathy Australia
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Address [3]
317581
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Country [3]
317581
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Osteopathy Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
319888
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Charities/Societies/Foundations
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Name [1]
319888
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Australian Research Council Osteoapthic Medicine
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Address [1]
319888
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Country [1]
319888
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Australia
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Secondary sponsor category [2]
319887
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Charities/Societies/Foundations
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Name [2]
319887
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Southerland Cranial Teaching FOundation AUS/NZ
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Address [2]
319887
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Country [2]
319887
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316288
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Southern Cross University Human Research Ethics Committee
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Ethics committee address [1]
316288
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https://www.scu.edu.au/research/research-excellence/research-ethics/
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Ethics committee country [1]
316288
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Australia
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Date submitted for ethics approval [1]
316288
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20/11/2023
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Approval date [1]
316288
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20/06/2024
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Ethics approval number [1]
316288
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2024/082
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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).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mrs Kirsty Greenwood
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Address
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Southern Cross University, Military Rd, East Lismore NSW 2480
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Country
137406
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Australia
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Phone
137406
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+61 0400443463
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Fax
137406
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Email
137406
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[email protected]
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Contact person for public queries
Name
137407
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Kirsty Greenwood
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Address
137407
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Southern Cross University, Military Rd, East Lismore NSW 2480
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Country
137407
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Australia
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Phone
137407
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+61 0400443463
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Fax
137407
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Email
137407
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[email protected]
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Contact person for scientific queries
Name
137408
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Kirsty Greenwood
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Address
137408
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Southern Cross University, Military Rd, East Lismore NSW 2480
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Country
137408
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Australia
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Phone
137408
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+61 0400443463
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Fax
137408
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Email
137408
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
PROTOCOL.pdf
Ethical approval
Approval notification.pdf
Informed consent form
PARTICIPANT CONSENT FORM FINAL.docx
Informed consent form
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.
Download to PDF