Cranial Osteopathy in Functional Disorders of the Newborn

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2016-10-31

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

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Detailed Description

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Conditions

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Newborn Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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cranial osteopathy

The group will receive treatment with osteopathic cranial osteopathy

Group Type EXPERIMENTAL

cranial osteopathy

Intervention Type OTHER

two sessions at three weeks intervals

comfort massage

The group will benefit from a placebo manipulation by an osteopathic student who has not yet been trained in cranial osteopathy.

Group Type PLACEBO_COMPARATOR

comfort massage

Intervention Type OTHER

manipulation, comfort massage, standardized and not affecting the skull

Interventions

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cranial osteopathy

two sessions at three weeks intervals

Intervention Type OTHER

comfort massage

manipulation, comfort massage, standardized and not affecting the skull

Intervention Type OTHER

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)

Minimum Eligible Age

1 Minute

Maximum Eligible Age

29 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No