Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour
- Conditions
- Breast Feeding, Exclusive
- Interventions
- Other: No Osteopathic manipulative TreatmentOther: Osteopathic Manipulative Treatment
- Registration Number
- NCT01890668
- Lead Sponsor
- Nantes University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group No Osteopathic manipulative Treatment Control group consists in classical medical and paramedical breastfeeding support. OMT on the newborn will be realized by osteopath dissimulated behind a screen. Placebo OMT consists to mimic, without the knowledge of parents, osteopathic techniques on a dolly. Osteopathic Manipulative Treatment Osteopathic Manipulative Treatment Randomization and first OMT will take place at discharge (Day 3); second osteopathic therapy will be performed by the same osteopath practitioner at Day10.
- Primary Outcome Measures
Name Time Method Efficacy assessment of osteopathic treatment on breastfeeding failure at 1 month of life. at 1 month of life. compare of breastfeeding failure percentage at one month of life between the two arms
- Secondary Outcome Measures
Name Time Method 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 compare the IBFAT score between the two consultation Cs1(day 3) and Cs2 (day 10)
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 assessment of maternal satisfaction between the Cs1, Cs2 and the visit at one month, by VAS
Description of breastfeeding initiation during the first month of life. at one month of life
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire de Nantes - Hôpital Mère-Enfant
🇫🇷Nantes, France