Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour
Condition: Breast Feeding, Exclusive
Study type: Interventional

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.
    


Intervention name(s): Osteopathic Manipulative Treatment; No Osteopathic manipulative Treatment
Intervention type(s): Other; Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Breastfeeding behaviour; OMT (Osteopathic Manipulative Treatment); suboptimal infant breastfeeding behaviour; healthy newborns