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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
128
Visit 1 between H60 and discharge : Interview (pregnancy step, initiation of breastfeeding, baby posture…) Osteopathic Clinical exam (osteopathic specific diagnosis, mobility…) Osteopathic Manipulative Treatment by sweet osteopathic mobilization Time of intervention = 30 to 45 min Visit 2 : 7 days after visit 1 (+/- 24H) with the same procedure To keep the blinded procedure the interventions will be realized behind a screen, allowing interactions with parents but depriving their visibility. A telephone contact will be perform at M1 (one month of life) to assess breastfeeding persistence and collect questionnaire data. Two others telephone contacts will be perform at 3 months and 6 months to precise breastfeeding interruption date. The follow-up for each patient is 6 months
Visit 1 between H60 and discharge : Interview (pregnancy steps, initiation of breastfeeding, baby posture…) Osteopathic Clinical exam and Treatment will not be realized. Newborn will be undressed, lying naked (covered with polar sheet) on the exam table, dissimulated to parents by adequate screen. The osteopathic procedure will take place on a dolly to mimic from an indiscernible manner, osteopathic management. Time of intervention = 30 to 45 min Visit 2: 7 days after visit 1 (+/- 24H) with the same procedure. To keep the blinded procedure the interventions will be realized behind a screen, allowing interactions with parents but depriving their visibility. A telephone contact will be perform at M1 (one month of life) to assess breastfeeding persistence and collect questionnaire data. Two others telephone contacts will be perform at 3 months and 6 months to precise breastfeeding interruption date. The follow-up for each patient is 6 months
Centre Hospitalier Universitaire de Nantes - Hôpital Mère-Enfant
Nantes, France
Efficacy assessment of osteopathic treatment on breastfeeding failure at 1 month of life.
compare of breastfeeding failure percentage at one month of life between the two arms
Time frame: at 1 month of life.
Compare IBFAT score (Infant Breast Feeding Assessment Tool score)
compare the IBFAT score between the two consultation Cs1(day 3) and Cs2 (day 10)
Time frame: at 10 days of life
Maternal satisfaction assessment
assessment of maternal satisfaction between the Cs1, Cs2 and the visit at one month, by VAS
Time frame: at one month of life
Safety assessment measured by per-treatment DAN score
Time frame: at 3 days of life
Preventive efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks
Time frame: at one month of life
Description of newborns behaviour during the first month of life (sleeping/awakening rhythm, cries and breastfeeding durations etc…) according treatment arm.
Time frame: at one month of life
Description of breastfeeding initiation during the first month of life.
Time frame: at one month of life
Assessment of differential efficacy according osteopathic practitioner profile (age/experience, perinatal specialization…)
Time frame: at 10 days of life
Description of osteopathic dysfunctions frequencies diagnosed by osteopath.
Time frame: at 10 days of life
Safety assessment measured by per-treatment DAN score
Time frame: at 10 days of life
Curative efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks
Time frame: at one month of life
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