Breastfeeding Osteopathic Manual Therapy Study - two-armed, multi-centre, pragmatic, randomised clinical trial, pilot and trial.

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.