Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour

Efficacy Assessment of Early Osteopathic Manipulative Treatment (OMT) in the Management of Suboptimal Breastfeeding Behaviour in Healthy Newborns. A Prospective Monocentric Randomized Double-blinded Study.

Breastfeeding is one of the prime factors of long-term health protection in newborns, for nutritional, immunological and developmental reasons. In France there is a wide inter-regional variability of breastfeeding rates at discharge. This variability associates different factors involving both, mothers, birth conditions, newborns and mother-child couple. Some approaches, including osteopathy, aim to support early breastfeeding difficulties. As many others non-conventional medicines, there is a huge and growing interest for this alternative therapy and a spontaneous recourse in the first months of life. Nevertheless, neither efficacy nor the benefits have been studied. Thus, our objective is to evaluate for the first time in France, in a randomized, double-blinded design, the efficacy of early osteopathic manipulative treatment (OMT), in suboptimal breastfeeding behaviour healthy newborns.

128 couples mother-child will be randomized in two groups: with or without osteopathic intervention on the newborn.

Inclusion Criteria:

• Healthy newborn ≥ 38 weeks of gestation,
• Suboptimal breastfeeding behavior defined by an IBFATmax score <10 after 2 assessments.(IBFATmax score = maximal score of Infant Breast Feeding Assessment Tool)
• And/ or presence of persistent severe pain (VAS> 5) at hospital discharge,
• And / or the presence of nipples cracks, grades 2-5 on the NTS scale
• Maternal Project of exclusive breastfeeding.
• Parental informed and consent form signed

Exclusion Criteria:

• Prematurity defined by a gestation <38 weeks
• Hypotrophy
• Maternal obesity (BMI>40)
• Multiple pregnancy
• Congenital malformation
• Neonatal pathology incompatible with efficient lactation initiation.
• Mothers minor or major and / or under guardianship and / or with poor understanding of French language
• Previous history of maternal breast surgery or umbilicated nipple
• IBFAT score max >10 on at least one of the two assessment at Day3.
• Medical contraindication to osteopathy: bone injury (fracture), tendon or ligament (sprain, dislocation etc ...) in the newborn incompatible with effective mobilization.
• Parental consent withdrawal.
• Neonatal pathology incompatible with breastfeeding follow-up in the first month of life.