Cranial Osteopathy in Functional Disorders of the Newborn

Interest of Treatment With Cranial Osteopathy in Functional Disorders of the Newborn

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 Overview

• Status: Completed
• Conditions: Newborn Complication
• Intervention / Treatment: Other: cranial osteopathy; Other: comfort massage

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Roubaix, France
    • Maternité Paul Gelé du CH de Roubaix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cranial osteopathy; The group will receive treatment with osteopathic cranial osteopathy	Other: cranial osteopathy; two sessions at three weeks intervals
Placebo Comparator: comfort massage; The group will benefit from a placebo manipulation by an osteopathic student who has not yet been trained in cranial osteopathy.	Other: comfort massage; manipulation, comfort massage, standardized and not affecting the skull

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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	at 28 days of life.

Secondary Outcome Measures

Outcome Measure	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: 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	before any treatment, at 3 days after deliverance and at 28 days of life

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Eric Boez, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: osteopathy; cranial
• Other Study ID Numbers: 2008_43; 2009-A00037-50 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No