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NCT Number: NCT06956768

Head Circumference Evolution in Children With Positional Plagiocephaly During and After Molding Helmet Therapy.

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children under 12 months of age with diagnosis of positional deformity of the cranium.
  • Treated with a cranial orthosis.

Exclusion criteria

  • Children with orthoses fitted before the consultation.
  • Children whose parents have not authorised data analysis.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Complications

    Time frame: From the beginning to 6 months after the the end of the treatment.

    Note the presence of any other complications that arose while wearing the helmet (yes/no):

    • Skin burns;
    • Slower acquisition;
    • Intolerance;
    • Other.
  2. Morphological aspects

    Time frame: From the enrollement to 6 months after the the end of the treatment.

    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.

  3. Aesthetics features

    Time frame: From the enrollement to 6 months after the end of the treatment

    Assess the presence of morphological severity criteria (yes/no): ear asymmetry, frontal asymmetry, compensatory growth.

  4. Radiological features

    Time frame: 6 months after the the end of the treatment.

    Evaluation of CT scans: presence of ptosis of the cerebellar tonsils (yes/no); presence of asymmetry of the base of the skull (yes/no).

  5. Radiological features

    Time frame: From the enrollement to 6 months after the end of the treatment

    Measurement of posterior fossa volume

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Helmet Therapy for Positional Cranial Deformities: Any Impact on Skull's Growth?

Acronym: PCPlagio

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 4, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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