Non Synostotic PlagiocephalyPCPlagioNCT06956768
Head Circumference Evolution in Children With Positional Plagiocephaly During and After Molding Helmet Therapy.
An observational study of Non Synostotic Plagiocephaly, run by Central Hospital, Nancy, France.
Trial summary
The aim of this study is to verify the growth of cranial circumference in children treated with helmets for positional skull deformity. The main questions it aims to answer are as follows: Does the helmet produce a reduction in cranial growth during the period in which it is worn? If the growth of the cranial… Read more about this study
- Who is it for?
- Ages 4 to 12 months
- Conditions the study is for
- Non Synostotic Plagiocephaly
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Referred to the Craniost Reference Center for Rares Diseases of the Nancy Regional University Hospital for a positional deformity of the cranium.
Who may be able to join
- Children under 12 months of age with diagnosis of positional deformity of the cranium.
- Treated with a cranial orthosis.
Who cannot join
- Children with orthoses fitted before the consultation.
- Children whose parents have not authorised data analysis.
About this study
Official title: Helmet Therapy for Positional Cranial Deformities: Any Impact on Skull's Growth?
The aim of this study is to verify the growth of cranial circumference in children treated with helmets for positional skull deformity. The main questions it aims to answer are as follows:
Does the helmet produce a reduction in cranial growth during the period in which it is worn? If the growth of the cranial circumference slows down while the helmet is being worn, does it recover a few months after the end of the treatment? The researchers will study changes in cranial circumference during and after helmet treatment.
The participants received helmet treatment as part of their usual medical care. They will be followed until medical attention is required and data will be collected retrospectively.
Read the detailed description
Cranial positional deformities in children are a major health problem in France, as in other countries, with a reported incidence of up to 47%. This phenomenon started to widespread in the 90s, but widely diffused in France after 2020, following paediatric recommendations for infants to be placed strictly on their backs in order to avoid sudden infant death syndrome.
Cranial deformation may be asymmetrical (plagiocephaly) or symmetrical (brachycephaly), depending on whether or not a torticollis or a positional preference coexist. The consequences of these deformations are mostly aesthetics, giving the fact that there is no brain compression nor sufferance. In some severe cases, compensational skull growth in the temporo-parietal region, uni- or bilaterally, is noticed immediately on frontal face view, accounting for a disgraceful facial appearance. This aspect is source of parental anxiety and distress, with feeling of guilty and fear for the future of their child.
A part from aesthetic consequences, while in brachycephaly, the symmetrical morphology of the skull justifies the fact that there are no functional consequences, in severe plagiocephaly, a skull base displacement may also be observed, with impact on the frontal region and advancement of the ipsilateral frontal bone, and consequent asymmetrical development of the mandibular and cervical musculoskeletal component.
Intensive stimulation of the child, often with the help of physiotherapists, became essential in order to prevent any deformities.
Despite educational efforts and preventive measures, many cases of positional skull deformity still occur and come to the attention of paediatric neurosurgeons. One of the solutions proposed in the most severe cases is the fitting of a custom-made cranial orthosis (helmet), capable to guide the remodelling of the skull and to reduce the deformity. As with all medical devices, the cranial orthosis is not without its risks and complications. Some of these complications, such as frontal skin burnt at helmet compression points, have already been widely described in the literature.
From personal experience, in patients who have been monitored while wearing the orthosis, it has been frequently observed an inflection of the curve of the cranial perimeter (CP) corresponding to the time the helmet is worn. For this reason, it is essential to measure the CP curve in children who have benefited from a helmet, in order to check that growth has restored some months after the treatment. Anyway, even if CP's reduction is minimal and spontaneously corrects, it is necessary for health care professionals and orthoprosthetist to be aware of this phenomenon, which implies a certain degree of cranial compression during helmet therapy.
- Conditions
- Non Synostotic Plagiocephaly
- Keywords
- deformational plagiocephaly, cranial circumpherence
- Medical subject headings
- Plagiocephaly, Nonsynostotic
What is being measured
The primary outcome is the main question the study is designed to answer.
Cranial circumpherence curve
Evaluation of changes in standard deviations of head circumference during and after wearing the helmet.
Measurement of cranial perimeter (CP):
- Value expressed in cm.
- Traceable on a standardised record curve; each value corresponds to a precise standard deviation (SD) on the curve: - 2SD, - 1.5SD, - 1SD, -0.5 SD, 0SD, + 0.5 SD, + 1SD, + 1.5SD, + 2SD.
Measured: 6 months after the the end of the treatment.
Secondary outcomes (5)
Complications
Note the presence of any other complications that arose while wearing the helmet (yes/no):
- Skin burns;
- Slower acquisition;
- Intolerance;
- Other.
Measured: From the beginning to 6 months after the the end of the treatment.
Morphological aspects
Evaluate the changes in the cranial indexes after treatment with the orthosis.
- Cranial Index (CI) = biparietal cranial diameter (LL)/ antero-posterior cranial diameter (AP)
- Cranial Vault Asymetry Index (CVAI) = major cranial diagonal (D1) - minor cranial diagonal (D2) x 100/D1
Values are expressed in cm.
Measured: From the enrollement to 6 months after the the end of the treatment.
Aesthetics features
Assess the presence of morphological severity criteria (yes/no): ear asymmetry, frontal asymmetry, compensatory growth.
Measured: From the enrollement to 6 months after the end of the treatment
Radiological features
Evaluation of CT scans: presence of ptosis of the cerebellar tonsils (yes/no); presence of asymmetry of the base of the skull (yes/no).
Measured: 6 months after the the end of the treatment.
Radiological features
Measurement of posterior fossa volume
Measured: From the enrollement to 6 months after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non Synostotic PlagiocephalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, STELLA Irène, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956768
- Sponsor's protocol ID
- CHRU Nancy : 2025PI044
- Acronym
- PCPlagio
- Status last verified
- Mar 2025
- First submitted
- 25 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I would like to share for transparency policy, but I don't have discussed yet with our data commitee.
Publications
Ballardini E, Sisti M, Basaglia N, Benedetto M, Baldan A, Borgna-Pignatti C, Garani G. Prevalence and characteristics of positional plagiocephaly in healthy full-term infants at 8-12 weeks of life. Eur J Pediatr. 2018 Oct;177(10):1547-1554. doi: 10.1007/s00431-018-3212-0. Epub 2018 Jul 20.
PubMed 30030600Picart T, Beuriat PA, Szathmari A, Di Rocco F, Mottolese C. Positional cranial deformation in children: A plea for the efficacy of the cranial helmet in children. Neurochirurgie. 2020 Apr;66(2):102-109. doi: 10.1016/j.neuchi.2019.10.011. Epub 2020 Jan 17.
PubMed 31958410Kreutz M, Fitze B, Blecher C, Marcello A, Simon R, Cremer R, Zeilhofer HF, Kunz C, Mayr J. Facial asymmetry correction with moulded helmet therapy in infants with deformational skull base plagiocephaly. J Craniomaxillofac Surg. 2018 Jan;46(1):28-34. doi: 10.1016/j.jcms.2017.10.013. Epub 2017 Oct 16.
PubMed 29221913
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helmet Therapy for Positional Cranial Deformities: Any Impact on Skull's Growth?
- ClinicalTrials.gov ID
- NCT06956768
- Acronym / sponsor ID
- PCPlagio / CHRU Nancy : 2025PI044
- Conditions
- Non Synostotic Plagiocephaly
- Keywords
- deformational plagiocephaly, cranial circumpherence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to verify the growth of cranial circumference in children treated with helmets for positional skull deformity. The main questions it aims to answer are as follows:
Does the helmet produce a reduction in cranial growth during the period in which it is worn? If the growth of the cranial circumference slows down while the helmet is being worn, does it recover a few months after the end of the treatment? The researchers will study changes in cranial circumference during and after helmet treatment.
The participants received helmet treatment as part of their usual medical care. They will be followed until medical attention is required and data will be collected retrospectively.
Detailed description
Cranial positional deformities in children are a major health problem in France, as in other countries, with a reported incidence of up to 47%. This phenomenon started to widespread in the 90s, but widely diffused in France after 2020, following paediatric recommendations for infants to be placed strictly on their backs in order to avoid sudden infant death syndrome.
Cranial deformation may be asymmetrical (plagiocephaly) or symmetrical (brachycephaly), depending on whether or not a torticollis or a positional preference coexist. The consequences of these deformations are mostly aesthetics, giving the fact that there is no brain compression nor sufferance. In some severe cases, compensational skull growth in the temporo-parietal region, uni- or bilaterally, is noticed immediately on frontal face view, accounting for a disgraceful facial appearance. This aspect is source of parental anxiety and distress, with feeling of guilty and fear for the future of their child.
A part from aesthetic consequences, while in brachycephaly, the symmetrical morphology of the skull justifies the fact that there are no functional consequences, in severe plagiocephaly, a skull base displacement may also be observed, with impact on the frontal region and advancement of the ipsilateral frontal bone, and consequent asymmetrical development of the mandibular and cervical musculoskeletal component.
Intensive stimulation of the child, often with the help of physiotherapists, became essential in order to prevent any deformities.
Despite educational efforts and preventive measures, many cases of positional skull deformity still occur and come to the attention of paediatric neurosurgeons. One of the solutions proposed in the most severe cases is the fitting of a custom-made cranial orthosis (helmet), capable to guide the remodelling of the skull and to reduce the deformity. As with all medical devices, the cranial orthosis is not without its risks and complications. Some of these complications, such as frontal skin burnt at helmet compression points, have already been widely described in the literature.
From personal experience, in patients who have been monitored while wearing the orthosis, it has been frequently observed an inflection of the curve of the cranial perimeter (CP) corresponding to the time the helmet is worn. For this reason, it is essential to measure the CP curve in children who have benefited from a helmet, in order to check that growth has restored some months after the treatment. Anyway, even if CP's reduction is minimal and spontaneously corrects, it is necessary for health care professionals and orthoprosthetist to be aware of this phenomenon, which implies a certain degree of cranial compression during helmet therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 4 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Referred to the Craniost Reference Center for Rares Diseases of the Nancy Regional University Hospital for a positional deformity of the cranium.
Key inclusion criteria (2 listed)
- Children under 12 months of age with diagnosis of positional deformity of the cranium.
- Treated with a cranial orthosis.
Key exclusion criteria (2 listed)
- Children with orthoses fitted before the consultation.
- Children whose parents have not authorised data analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cranial circumpherence curve
Time frame: 6 months after the the end of the treatment.
Evaluation of changes in standard deviations of head circumference during and after wearing the helmet. Measurement of cranial perimeter (CP): * Value expressed in cm. * Traceable on a standardised record curve; each value corresponds to a precise standard deviation (SD) on the curve: - 2SD, - 1.5SD, - 1SD, -0.5 SD, 0SD, + 0.5 SD, + 1SD, + 1.5SD, + 2SD.
5 secondary outcomes
Complications
Time frame: From the beginning to 6 months after the the end of the treatment.
Morphological aspects
Time frame: From the enrollement to 6 months after the the end of the treatment.
Aesthetics features
Time frame: From the enrollement to 6 months after the end of the treatment
Radiological features
Time frame: 6 months after the the end of the treatment.
Radiological features
Time frame: From the enrollement to 6 months after the end of the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Background: PubMed 30030600Ballardini E, Sisti M, Basaglia N, Benedetto M, Baldan A, Borgna-Pignatti C, Garani G. Prevalence and characteristics of positional plagiocephaly in healthy full-term infants at 8-12 weeks of life. Eur J Pediatr. 2018 Oct;177(10):1547-1554. doi: 10.1007/s00431-018-3212-0. Epub 2018 Jul 20.
- Background: PubMed 31958410Picart T, Beuriat PA, Szathmari A, Di Rocco F, Mottolese C. Positional cranial deformation in children: A plea for the efficacy of the cranial helmet in children. Neurochirurgie. 2020 Apr;66(2):102-109. doi: 10.1016/j.neuchi.2019.10.011. Epub 2020 Jan 17.
- Background: PubMed 29221913Kreutz M, Fitze B, Blecher C, Marcello A, Simon R, Cremer R, Zeilhofer HF, Kunz C, Mayr J. Facial asymmetry correction with moulded helmet therapy in infants with deformational skull base plagiocephaly. J Craniomaxillofac Surg. 2018 Jan;46(1):28-34. doi: 10.1016/j.jcms.2017.10.013. Epub 2017 Oct 16.
- Official High Health Authority of France document.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. I would like to share for transparency policy, but I don't have discussed yet with our data commitee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Synostotic Plagiocephaly, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cranial circumpherence curve (time frame: 6 months after the the end of the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06956768, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.