Preventive Osteopathic Treatment of Plagiocephaly (TOPP PLAGIO)
Primary Purpose
Positilonal Deformation of the Skull, Head Turn Preference, Axial Hypertony
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
manual therapy/osteopathy
Sponsored by
About this trial
This is an interventional prevention trial for Positilonal Deformation of the Skull
Eligibility 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.
Sites / Locations
- CHU Arnaud de Villeneuve
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Osteopathic treatment
Control group
Arm Description
Outcomes
Primary Outcome Measures
Positionnal skull deformation : plagiocephaly and brachycephaly
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
Questionnaire QUALIN
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)
Full Information
NCT ID
NCT03780920
First Posted
December 13, 2018
Last Updated
December 13, 2022
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03780920
Brief Title
Preventive Osteopathic Treatment of Plagiocephaly
Acronym
TOPP PLAGIO
Official Title
Interest of an Early Osteopathic Treatment in Infants in the Prevention of Cranial Deformations : Positional Plagiocephaly and Brachycephaly.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
January 21, 2022 (Actual)
Study Completion Date
January 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Positilonal Deformation of the Skull, Head Turn Preference, Axial Hypertony
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Osteopathic treatment
Arm Type
Active Comparator
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
manual therapy/osteopathy
Intervention Description
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
Primary Outcome Measure Information:
Title
Positionnal skull deformation : plagiocephaly and brachycephaly
Description
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
Time Frame
four month
Secondary Outcome Measure Information:
Title
Questionnaire QUALIN
Description
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)
Time Frame
fourth month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
11 Days
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume CAPTIER, Pr
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Arnaud de Villeneuve
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Preventive Osteopathic Treatment of Plagiocephaly
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