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Gentle hands, round heads: osteopathy may stop baby skull flattening

NCT ID NCT03780920

Prevention Sponsor: University Hospital, Montpellier Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether early osteopathic treatment in newborns with risk factors (like a preferred head turn or muscle tightness) could prevent positional skull deformities (flat head). 101 babies were randomly assigned to receive either osteopathic sessions plus standard advice, or just standard advice. The main goal was to see if the treatment reduced the rate of plagiocephaly and brachycephaly at 4 months old.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

101 people

The number who actually took part.

Started

Feb 2019

Finished

Jan 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 11 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

craniosynostosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Axial hypertony Head turn preference Positilonal deformation of the skull

Contacts and locations

Locations

  • CHU Arnaud de Villeneuve

    Montpellier, Hérault, 34000, France