Cranial Osteopathy in Functional Disorders of the Newborn

Study Overview
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Brief Summary
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To evaluate, from the maternity stay, the interest of the cranial osteopathy in the reduction of the hyper irritability of the newborn and the improvement of the postural abnormalities

Official Title
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Interest of Treatment With Cranial Osteopathy in Functional Disorders of the Newborn

Conditions
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Newborn Complication

Intervention / Treatment
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* Other: cranial osteopathy
* Other: comfort massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newborns: forward born vaginally or cesarean section with or without general anesthesia with or without epidural or spinal anesthesia with or without instrumental extraction presenting at least 1 of the 4 criteria detailed above, numbered at 3 or 4 or two criteria at 2 Exclusion Criteria: Newborns presenting: a score of Amiel <7, signing a strong suspicion of non-integrity of brain functions (see table) and therefore leaving the framework of functional pathology symptomatic maternal-fetal infection true obstetric trauma: brachial plexus paralysis, fracture or of a mother who has taken during pregnancy drugs or toxic drugs that affect the behavior of the newborn. (benzodiazepines, subutex, methadone, cocaine, heroin or cannabis)

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 29 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cranial osteopathy<br>The group will receive treatment with osteopathic cranial osteopathy | Other: cranial osteopathy<br>* two sessions at three weeks intervals<br>|
| Placebo Comparator: comfort massage<br>The group will benefit from a placebo manipulation by an osteopathic student who has not yet been trained in cranial osteopathy. | Other: comfort massage<br>* manipulation, comfort massage, standardized and not affecting the skull<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of hyper irritability | Reduction of hyper irritability will be done by evaluation from a clinical score,signs of hyper irritability during stay in maternity or postural disorders: one of the following 4 criteria rated 3 or 4, or at least two of these rated criteria 2: Excessive and difficult to calm, insufficient sleep postural asymmetry difficulties in feeding, ineffective suckling, including asymmetries (babies breastfeeding and refusing each other), difficulty suckling Excessive regurgitation | at 28 days of life. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of hyper irritability | Reduction of hyper irritability will be done by evaluation from a clinical score, signs of hyper irritability during stay in maternity or postural disorders: one of the following 4 criteria rated 3 or 4, or at least two of these rated criteria 2: Excessive and difficult to calm, insufficient sleep postural asymmetry difficulties in feeding, ineffective suckling, including asymmetries (babies breastfeeding and refusing each other), difficulty suckling Excessive regurgitation | before any treatment, at 3 days after deliverance and at 28 days of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteopathy, cranial