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Tiny trial compares skull surgery techniques for babies

NCT ID NCT04721769

Disease control Sponsor: Baylor College of Medicine 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study compared two ways of doing endoscopic strip craniectomy (a keyhole surgery to remove a fused skull seam) in infants under 6 months with sagittal craniosynostosis. The goal was to see which method leads to better head shape and fewer complications. Only 6 babies were enrolled before the trial was stopped early, so the findings are very limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Endoscopic strip craniectomy (surgery to remove fused skull bone) plus post-operative helmet therapy
What this could lead to
If successful, this could show which surgical technique gives better head shape and fewer complications for infants with this skull condition.
What could go wrong
The trial was terminated early with only 6 participants, so results are very limited. It is a small, early-stage comparison, not a test of a new treatment.

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

6 people

The number who actually took part.

Started

Dec 2020

Finished

May 2025

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

Up to 6 months

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: * All patients with isolated, non-syndromic sagittal craniosynostosis under 6 months of age who present to Texas Children's Hospital. Exclusion Criteria: * Patients who are unable to undergo endoscopic strip craniectomy by 6 months of age.

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Conditions

The condition(s) this trial relates to.

craniosynostosis isolated craniosynostosis

As listed by the trial registrant

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

Craniosynostosis, sagittal

Contacts and locations

Locations

  • Texas Children's Hospital

    Houston, Texas, 77030, United States