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Helmet therapy for baby flat heads: new study looks at neck and heat effects
NCT ID NCT07201324
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will follow 270 children with severe positional head deformity who are already using a cranial helmet. Researchers will measure head shape changes, neck rotation, and body surface temperature using thermal imaging. The goal is to understand how helmet therapy might influence neck movement and temperature regulation, and what factors like age and sex affect treatment success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cranial helmet therapy
- What this could lead to
- If successful, this study could help doctors understand how helmet therapy affects neck movement and body temperature, potentially improving treatment guidelines.
- What could go wrong
- This is an observational study, not a treatment trial. It will not test whether helmets work, only explore related factors. Results may not change current practice.
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 270 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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May 2027
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
Participants are children from various cities in Poland, aged 4-12 months, diagnosed with severe or very severe positional head deformity and referred for cranial helmet therapy by a neurosurgeon. Both boys and girls are included. All referring physicians used the same standardized scale to determine the severity of the deformity, ensuring consistency across sites.
- Ages
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4 to 12 months
- 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: * positional head deformity of severe or very severe degree; * age at therapy initiation: 4-12 months; * minimum therapy duration of 12 weeks (for Stage 1 and Stage 2). Exclusion Criteria: * craniosynostosis; * hydrocephalus; * non-adherence to 23-hour daily helmet use; * metabolic disorders; * torticollis.
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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 official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
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Other studies related to the condition(s) this trial covers.