Cranial Osteopathy in Functional Disorders of the Newborn

NCT03751787 | Completed

• 2 other identifiers: 2008_432009-A00037-50
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Newborn Complication

Keywords

osteopathy; cranial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction of hyper irritability

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

Study Arms (2)

cranial osteopathy

EXPERIMENTAL

The group will receive treatment with osteopathic cranial osteopathy

Other: cranial osteopathy

comfort massage

PLACEBO COMPARATOR

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

Other: comfort massage

Interventions

cranial osteopathy OTHER

two sessions at three weeks intervals

cranial osteopathy

comfort massage OTHER

manipulation, comfort massage, standardized and not affecting the skull

comfort massage

Eligibility Criteria

• Age: 1 Minute - 29 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Maternité Paul Gelé du CH de Roubaix

Roubaix, France

Location

Study Officials

• Eric Boez, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 23, 2018
• Study Start: September 1, 2009
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 23, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)