Newborn Complication
Conditions
Keywords
osteopathy, cranial
Brief summary
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
Interventions
OTHERcranial osteopathy
two sessions at three weeks intervals
OTHERcomfort massage
manipulation, comfort massage, standardized and not affecting the skull
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 29 Days
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of hyper irritability | at 28 days of life. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of hyper irritability | before any treatment, at 3 days after deliverance and at 28 days of life | 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 |
Countries
France
Outcome results
None listed