Completed

NCT Number: NCT03780920

Preventive Osteopathic Treatment of Plagiocephaly

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.

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Key information

Conditions

Positilonal Deformation of the Skull Axial Hypertony Head Turn Preference

Age range

3 day–11 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Arnaud de Villeneuve

Montpellier, Hérault, 34000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

manual therapy/osteopathy

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

Primary outcomes

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

Secondary outcomes

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)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: TOPP PLAGIO

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Dec 19, 2018
Registry last updated: Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.