Can some children with a pointed skull skip major surgery?
NCT ID NCT06069479
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Trigonocephaly is a condition where a baby's skull fuses too early along the forehead, giving the head a pointed shape. Doctors often operate to relieve pressure on the growing brain, but some children may do just as well without surgery. This study follows children aged 0 to 8 who receive either craniofacial surgery or conservative care, tracking head growth, vision, thinking, behavior, forehead shape, parent stress, and costs over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- craniofacial surgery, either strip craniectomy or fronto-orbital advancement
- What this could lead to
- If surgery and conservative care prove comparable, some children with trigonocephaly could avoid major skull surgery and its risks.
- What could go wrong
- This is an observational study, so it cannot prove cause and effect. Families choose their own treatment, and the groups may differ in ways that skew the comparison.
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
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About 440 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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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
Children with mild, moderate or severe trigonocephaly, between 0 and 8 years of age, excluding metopic ridge (i.e. physiologic early closure of metopic suture).
- Ages
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Up to 8 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * diagnosis of trigonocephaly Exclusion Criteria: * metopic ridge (physiologic early closure of metopic suture)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Erasmus MC
RECRUITINGRotterdam, 3012LE, Netherlands