Preventive Osteopathic Treatment of Plagiocephaly (TOPP PLAGIO)
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|ClinicalTrials.gov Identifier: NCT03780920|
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : December 14, 2022
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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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
|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|
- 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
- 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)
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|Ages Eligible for Study:||3 Days to 11 Days (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- a preferential side,
- global axial hypertonia,
- Localized suboccipital hypertonia
- cranial deformity at birth,
- a deformation of the face,
- deformity of the trunk in scoliosis, comma or hyperextension
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.
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
|CHU Arnaud de Villeneuve|
|Montpellier, Hérault, France, 34000|
|Principal Investigator:||Guillaume CAPTIER, Pr||University Hospital, Montpellier|
|Responsible Party:||University Hospital, Montpellier|
|Other Study ID Numbers:||
|First Posted:||December 19, 2018 Key Record Dates|
|Last Update Posted:||December 14, 2022|
|Last Verified:||December 2018|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|