Cranial Osteopathy in Functional Disorders of the Newborn

Not Applicable

Completed

• Conditions: Newborn Complication
• Interventions: Other: cranial osteopathy; Other: comfort massage

• Registration Number: NCT03751787
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2018-11
• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-21
• Last Update Submitted: 2018-11-21
• Study First Posted: 2018-11-23
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cranial osteopathy	cranial osteopathy	The group will receive treatment with osteopathic cranial osteopathy
comfort massage	comfort massage	The group will benefit from a placebo manipulation by an osteopathic student who has not yet been trained in cranial osteopathy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Maternité Paul Gelé du CH de Roubaix; 🇫🇷 Roubaix, France