Cranial Osteopathy in Functional Disorders of the Newborn

University Hospital, Lille60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Newborn Complication

Interventions

cranial osteopathyOTHER

two sessions at three weeks intervals

comfort massageOTHER

manipulation, comfort massage, standardized and not affecting the skull

Eligibility

Sex: ALLMin age: 1 MinuteMax age: 29 Days

Medical Language ↔ Plain English

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)

Locations (1)

Maternité Paul Gelé du CH de Roubaix

Roubaix, France

Outcomes

Primary Outcomes

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

Time frame: at 28 days of life.

Secondary Outcomes

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

Time frame: before any treatment, at 3 days after deliverance and at 28 days of life

Data from ClinicalTrials.gov

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