Clinical trial NCT01890668: Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding, Exclusive
Keywords: Breastfeeding behaviour
OMT (Osteopathic Manipulative Treatment)
suboptimal infant breastfeeding behaviour
healthy newborns
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-07-02
Enrollment: 128
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: Efficacy assessment of osteopathic treatment on breastfeeding failure at 1 month of life.
timeFrame: at 1 month of life.
Secondary outcomes:
measure: Compare IBFAT score (Infant Breast Feeding Assessment Tool score)
timeFrame: at 10 days of life
measure: Maternal satisfaction assessment
timeFrame: at one month of life
measure: Safety assessment measured by per-treatment DAN score
timeFrame: at 3 days of life
measure: Preventive efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks
timeFrame: at one month of life
measure: Description of newborns behaviour during the first month of life (sleeping/awakening rhythm, cries and breastfeeding durations etc…) according treatment arm.
timeFrame: at one month of life
measure: Description of breastfeeding initiation during the first month of life.
timeFrame: at one month of life
measure: Assessment of differential efficacy according osteopathic practitioner profile (age/experience, perinatal specialization…)
timeFrame: at 10 days of life
measure: Description of osteopathic dysfunctions frequencies diagnosed by osteopath.
timeFrame: at 10 days of life
measure: Safety assessment measured by per-treatment DAN score
timeFrame: at 10 days of life
measure: Curative efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks
timeFrame: at one month of life
Other outcomes:
Locations:
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - Hôpital Mère-Enfant
Study officials:
affiliation: Centre Hospitalier Universitaire de Nantes, France
name: Jean-Baptiste MULLER, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Danielo Jouhier M, Boscher C, Roze JC, Cailleau N, Chaligne F, Legrand A, Flamant C, Muller JB; NEOSTEO osteopath study group. Osteopathic manipulative treatment to improve exclusive breast feeding at 1 month. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):591-595. doi: 10.1136/archdischild-2020-319219. Epub 2021 Mar 31.