Cranial Osteopathy in Functional Disorders of the Newborn

Newborn Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03751787
• Other study ID #: 2008_43
• Secondary ID: 2009-A00037-50
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: October 2016

Study information

• Verified date: November 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 29 Days

Eligibility

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)

Related Conditions & MeSH terms

• Newborn Complication

Intervention

Other:
• cranial osteopathy
two sessions at three weeks intervals
• comfort massage
manipulation, comfort massage, standardized and not affecting the skull

Locations

Country	Name	City	State
France	Maternité Paul Gelé du CH de Roubaix	Roubaix

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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