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Infant skull study aims to unlock secrets of craniosynostosis

NCT ID NCT07650981

Knowledge-focused Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study looks at skull bone samples from 80 infants aged 3 to 12 months who have craniosynostosis, a condition where skull bones fuse too early. Researchers will measure the bone's strength, structure, and tissue makeup both near and far from the fused area. The goal is to better understand how healthy and diseased skull bones differ, which may improve future treatments.

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.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

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.

Who is studied

80 Infants aged 3 to 12 months requiring craniostenosis surgery and care at the Women's and Children's Hospital (HFME) in the pediatric neurosurgery department

Ages

3 to 12 months

Sex

Anyone

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: * Patients diagnosed with craniosynostosis by a pediatric neurosurgeon. * Patients treated in the neurosurgery department of Prof. Federico Di Rocco at the Hôpital Femme Mère Enfant. * Patients aged 3 to 12 months. Exclusion Criteria: * Positional cranial deformities * History of previous cranial surgery in the parietal region (including osteotomies, implant placement, or cranioplasty). * Recent significant head trauma (\< 6 months) involving the cranial vault. * Documented metabolic bone disease (e.g., osteogenesis imperfecta, uncorrected clinical or biochemical rickets). * Severe systemic disease likely to alter bone metabolism (e.g., advanced chronic kidney disease, severe liver disease, uncontrolled endocrine disorders). * Pharmacological treatment likely to significantly alter bone composition/biomechanics within the last 6 months (e.g., prolonged systemic corticosteroids, bisphosphonates, other antiresorptive agents, chemotherapy). * Refusal by parents/guardians to participate

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Conditions

The condition(s) this trial relates to.

craniosynostosis TWIST1-related craniosynostosis

As listed by the trial registrant

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

Craniostenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hopital Femme MèreEnfant / Hospices Civils de Lyon

    Bron, Rhone, 69500, France