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

NCT06956768 | Not Yet Recruiting DMC

• 1 other identifier: CHRU Nancy : 2025PI044
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Non Synostotic Plagiocephaly

Keywords

deformational plagiocephaly; cranial circumpherence

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after the the end of the treatment.

Secondary Outcomes (5)

• Complications

  From the beginning to 6 months after the the end of the treatment.

• Morphological aspects

  From the enrollement to 6 months after the the end of the treatment.

• Aesthetics features

  From the enrollement to 6 months after the end of the treatment

• Radiological features

  6 months after the the end of the treatment.

• Radiological features

  From the enrollement to 6 months after the end of the treatment

Eligibility Criteria

• Age: 4 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Referred to the Craniost Reference Center for Rares Diseases of the Nancy Regional University Hospital for a positional deformity of the cranium.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Related Publications (3)

• 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.

  PMID: 30030600 BACKGROUND

• Picart 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.

  PMID: 31958410 BACKGROUND

• Kreutz 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.

  PMID: 29221913 BACKGROUND

Related Links

• Official High Health Authority of France document.

MeSH Terms

Conditions

Plagiocephaly, Nonsynostotic

Condition Hierarchy (Ancestors)

Plagiocephaly; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 4, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-03