JRCT ID: jRCTs032220285
Registered date:22/08/2022
Safety and efficacy of cranial remolding helmet with ventilation mechanism for treatment of deformational plagiocephaly
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | deformational plagiocephaly |
Date of first enrollment | 22/08/2022 |
Target sample size | 5 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | cranial remolding helmet with ventilation mechanism |
Outcome(s)
Primary Outcome | safety outcome: adverse events during helmet therapy |
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Secondary Outcome | efficacy outcome: improvement in cranial asymmetry other outcomes: Argenta classification, cephalic index, head circumference, number of unexpected extra visit for helmet adjustment. |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | < 6month old |
Gender | Both |
Include criteria | 1. Patients with deformational plagiocephaly 2. Patients who are younger than 6 months old at the start of helmet therapy 3. Patients with cranial asymmetry =>15 4. Patients who gained head and neck control 5. Patients whose guardians showed informed consent |
Exclude criteria | 1. Patients with conditions which affect cranial shape (ie: hydrocephalus, craniosynostosis). 2. Patients with syndrome and other systemic comorbidity. 3. Patients with comorbidity of other organs (ie: metabolic disorders, heart defects). 4. Patients with disorders of head skin which makes helmet therapy difficult. 5. Patients who are expected to be lost to follow up during the study period. 6. Patients who are judged to be inappropriate by the investigator. |
Related Information
Primary Sponsor | Hikosaka Makoto |
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Secondary Sponsor | |
Source(s) of Monetary Support | Marubeni Information Systems Co., Ltd. |
Secondary ID(s) |
Contact
Public contact | |
Name | Makoto Hikosama |
Address | 2-10-1 Okura Setagaya-ku Tokyo Tokyo Japan 157-8535 |
Telephone | +81-3-3416-0181 |
hikosaka-m@ncchd.go.jp | |
Affiliation | National Center for Child Health and Development |
Scientific contact | |
Name | Makoto Hikosaka |
Address | 2-10-1 Okura Setagaya-ku Tokyo Tokyo Japan 157-8535 |
Telephone | +81-3-3416-0181 |
hikosaka-m@ncchd.go.jp | |
Affiliation | National Center for Child Health and Development |