Preventive Osteopathic Treatment of Plagiocephaly

NCT ID: NCT03780920

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-14
• Study Completion Date: 2022-01-21

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.

Conditions

Positilonal Deformation of the Skull; Head Turn Preference; Axial Hypertony

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Osteopathic treatment

Group Type: ACTIVE_COMPARATOR

manual therapy/osteopathy

Intervention Type: PROCEDURE

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

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 11 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume CAPTIER, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

CHU Arnaud de Villeneuve

Montpellier, Hérault, France

Countries

France

Other Identifiers

RECHMPL18_0207

Identifier Type: -

Identifier Source: org_study_id