Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour (NCT01890668) | Clinical Trial Compass
CompletedNot Applicable
Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour
France128 participantsStarted 2013-07
Plain-language 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.
Who can participate
Age range
1 Day – 4 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy assessment of osteopathic treatment on breastfeeding failure at 1 month of life.