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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-A00037-50 | Other Identifier | ID-RCB number, ANSM |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cranial osteopathy | Experimental | The group will receive treatment with osteopathic cranial osteopathy |
|
| comfort massage | Placebo Comparator | The group will benefit from a placebo manipulation by an osteopathic student who has not yet been trained in cranial osteopathy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cranial osteopathy | Other | two sessions at three weeks intervals |
| |
| 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:
| at 28 days of life. |
| 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:
|
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Inclusion Criteria:
Newborns:
Exclusion Criteria:
Newborns presenting:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Boez, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternité Paul Gelé du CH de Roubaix | Roubaix | France |
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| comfort massage |
| Other |
manipulation, comfort massage, standardized and not affecting the skull |
|
| before any treatment, at 3 days after deliverance and at 28 days of life |