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Preventive Osteopathic Treatment of Plagiocephaly (TOPP PLAGIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03780920
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : December 14, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:

Positional cranial deformities (PCD), plagiocephaly and brachycephaly are a common reason for pediatric consultation, which has increased significantly since the recommendation to lay babies on their backs to prevent unexpected infant death (ILD). CPD is a source of concern for parents about their impact on psychomotor development and the aesthetic risk of deformity. The High Authority for Health (HAS) will soon put in place recommendations with a fact sheet for health professionals and the public. The aim of this research is to study whether early treatment of rotation disorders and hypertonia in newborns by manual osteopathic techniques would prevent the occurrence of positional deformities of the skull.

The main objective is to evaluate the effectiveness of an early osteopathic treatment on the rate of CPP (plagiocephalic and postural brachycephalia) at 4 months in newborns at risk.

the secondary objective is: to evaluate the effectiveness of an early osteopathic treatment on the quality of life of the child at 4 months.

Methodology: Controlled, randomized monocentric two-arm parallel study between (1) osteopathic follow-up and (2) osteopathy-free follow-up. The inclusion period will be 18 months and the follow-up period is 4 months.

Procedure: The two groups will be evaluated at 3 days and 4 months. The experimental group will benefit from an osteopathic treatment of 3 days of life to 4 months with a frequency of 3 to 4 sessions. Both groups will benefit from sleeping, carrying, positioning and stimulation advice.

The perspectives are:

  • the decrease in the prevalence of CPP after early osteopathic treatment.
  • Defining a decision algorithm for early osteopathic treatment.
  • Subject to recommendations on the indication of early osteopathic treatment in neonates at risk.

Condition or disease Intervention/treatment Phase
Positilonal Deformation of the Skull Head Turn Preference Axial Hypertony Procedure: manual therapy/osteopathy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Interest of an Early Osteopathic Treatment in Infants in the Prevention of Cranial Deformations : Positional Plagiocephaly and Brachycephaly.
Actual Study Start Date : February 14, 2019
Actual Primary Completion Date : January 21, 2022
Actual Study Completion Date : January 21, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Osteopathic treatment Procedure: manual therapy/osteopathy

In this group, children will benefit from early osteopathic treatment over a period ranging from the third day to 4 months. The number of sessions will not be fixed, on average, 3 sessions will be carried out during this period at the University Hospital of Montpellier.

The duration of the session will be between 20 minutes to 30 or even 40 minutes
No Intervention: Control group


Outcome Measures
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Primary Outcome Measures :
  1. Positionnal skull deformation : plagiocephaly and brachycephaly [ Time Frame: four month ]
    cranial vault asymetry index and cranial index measured with caliper between the age of 3 to 10 days and at 4 months measured blind of the randomization arm


Secondary Outcome Measures :
  1. Questionnaire QUALIN [ Time Frame: fourth month ]
    the"questionnaire QUALIN" is a quality of life assessment questinniare for infant under 3 months of age, valided in Europe(French, Spanish, English and Italian)


Eligibility Criteria
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Ages Eligible for Study:   3 Days to 11 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newborn baby aged 3 days and until the maternity leave

  • Newborn with at least one risk factor for cranial deformity:

    • Newborn who received instrumental vaginal delivery.

    • Newborn presenting:

      • a preferential side,
      • global axial hypertonia,
      • Localized suboccipital hypertonia

    • Newborn presenting:

      • cranial deformity at birth,
      • a deformation of the face,
      • deformity of the trunk in scoliosis, comma or hyperextension

Exclusion Criteria:

  • Newborn with congenital muscular torticollis (managed directly in physiotherapy)

    • Premature neonate (<37SA)
    • Newborn with a malformation pathology
    • Newborn with craniosynostosis.
    • Newborn with a contraindication to the practice of osteopathy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780920


Locations
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France
CHU Arnaud de Villeneuve
Montpellier, Hérault, France, 34000
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Guillaume CAPTIER, Pr University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03780920    
Other Study ID Numbers: UF 7660
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 14, 2022
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Plagiocephaly
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities