Osteopathic treatment and infant feeding feasibility study (OTIFF)
Research type
Research Study
Full title
DOES THE ADDITION OF OSTEOPATHIC TREATMENT TO SPECIALIST BREASTFEEDING SUPPORT IMPROVE BREAST FEEDING OUTCOMES FOR INFANTS WITH BIOMECHANICAL SUCKING DIFFICULTIES? A FEASIBILITY STUDY
IRAS ID
236383
Contact name
Sally Tedstone
Contact email
Sponsor organisation
Royal United Hospitals Bath NHS Foundation Trust
Clinicaltrials.gov Identifier
2018-000038-37 , The EudraCT number
Duration of Study in the UK
0 years, 8 months, 26 days
Research summary
The aim of the study is to test the feasibility of a single blind randomised controlled trial (RCT) to establish the effectiveness of osteopathic treatment for infants with biomechanical sucking difficulties that are causing significant breastfeeding problems.
Breastfeeding is important for the health of infants and their mothers’( Gummer-Straw 2015). Effective infant suckling is necessary for successful breastfeeding( Genna 2013). Early breastfeeding difficulties are common, but many resolve with skilled support. Occasionally, an infant is not able to suck effectively and can be described as having a biomechanical suckling difficulty. In the context of this study, this means that the infant is thought to have physical strains their bodies, originating either from birth or a mal position in utero that may be contributing to the presenting suckling difficulties(Cornall 2013) . There is currently very limited evidence to guide us in supporting breastfeeding for this group. Parent reports suggest that this group of infants receive benefit from osteopathic treatment. An evidence base is emerging to support the experience of parents but further work is needed
A feasibility study is a study that assesses whether the plan for how to carry out a study can be done. The proposed study will identify infants who are thought to have a biomechanical suckling difficulties who will (with consent) be randomly allocated to receive osteopathic treatment or sham osteopathic treatment The study will run for one year (recruitment phase approximately 8 months).
Grummer-Strawn, L.M. , Rollins,N. (2015) ‘Summarising the health effects of breastfeeding’, Acta Paediatrica Volume 104, Issue S467December 2015 Pages 1–2
Genna , CW. (2013) Supporting Suckling Skills in Breastfeeding Infants . Joes and Barlett Learning . Woodhaven, NewYork
Cornall, D. (2015) Promoting Optimal Breastfeeding Through the Osteopathic Theraputic Cycle. PhD Thesis accessed nonline 6th December 2017 http://vuir.vu.edu.au/26290/1/Denise%20Cornall.pdfREC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
18/SW/0066
Date of REC Opinion
16 May 2018
REC opinion
Further Information Favourable Opinion