Preventive Osteopathic Treatment of Plagiocephaly (TOPP PLAGIO)

Interest of an Early Osteopathic Treatment in Infants in the Prevention of Cranial Deformations : Positional Plagiocephaly and Brachycephaly.

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.

Study Overview

• Status: Completed
• Conditions: Positilonal Deformation of the Skull; Head Turn Preference; Axial Hypertony
• Intervention / Treatment: Procedure: manual therapy/osteopathy

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume CAPTIER, Pr; Phone Number: 0467336733; Email: g-captier@chu-montpellier.fr
• Study Contact Backup: Name: Claire CHAUVETON; Phone Number: 0467330924

Study Locations

• France
  • Hérault
    • Montpellier, Hérault, France, 34000
      • CHU Arnaud de Villeneuve

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days to 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Guillaume CAPTIER, Pr, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2019
• Primary Completion (Actual): January 21, 2022
• Study Completion (Actual): January 21, 2022

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Plagiocephaly
• Other Study ID Numbers: UF 7660

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No