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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Feeding, Exclusive
- Sponsor
- Nantes University Hospital
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Efficacy assessment of osteopathic treatment on breastfeeding failure at 1 month of life.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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 Day
- •Medical contraindication to osteopathy: bone injury (fracture), tendon or ligament (sprain, dislocation etc ...) in the newborn incompatible with effective mobilization.
Outcomes
Primary Outcomes
Efficacy assessment of osteopathic treatment on breastfeeding failure at 1 month of life.
Time Frame: at 1 month of life.
compare of breastfeeding failure percentage at one month of life between the two arms
Secondary Outcomes
- Safety assessment measured by per-treatment DAN score(at 10 days of life)
- Description of osteopathic dysfunctions frequencies diagnosed by osteopath.(at 10 days of life)
- Compare IBFAT score (Infant Breast Feeding Assessment Tool score)(at 10 days of life)
- Description of newborns behaviour during the first month of life (sleeping/awakening rhythm, cries and breastfeeding durations etc…) according treatment arm.(at one month of life)
- Assessment of differential efficacy according osteopathic practitioner profile (age/experience, perinatal specialization…)(at 10 days of life)
- Preventive efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks(at one month of life)
- Curative efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks(at one month of life)
- Maternal satisfaction assessment(at one month of life)
- Description of breastfeeding initiation during the first month of life.(at one month of life)