Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour (NEOSTEO)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Breast Feeding, Exclusive

Treatments: Other: Osteopathic Manipulative Treatment; Other: No Osteopathic manipulative Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01890668

RC12_0379

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 1 to 4 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups, including a placebo group

Osteopathic Manipulative Treatment

Experimental group

Description:

Randomization and first OMT will take place at discharge (Day 3); second osteopathic therapy will be performed by the same osteopath practitioner at Day10.

Treatment:

Other: Osteopathic Manipulative Treatment

Control group

Placebo Comparator group

Description:

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.

Treatment:

Other: No Osteopathic manipulative Treatment