Axial Hypertony Clinical Trial
— TOPP PLAGIOOfficial title:
Interest of an Early Osteopathic Treatment in Infants in the Prevention of Cranial Deformations : Positional Plagiocephaly and Brachycephaly.
| Verified date | December 2018 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 101 |
| Est. completion date | January 21, 2022 |
| Est. primary completion date | January 21, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Days to 11 Days |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Arnaud de Villeneuve | Montpellier | Hérault |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | four month | |
| Secondary | 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) | fourth month |