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Multicenter Research for Non-invasive Orthopedic Correction of Ear Malformations in Newborns in Sichuan Province

Multicenter Research for Non-invasive Orthopedic Correction of Ear Malformations in Newborns in Sichuan Province

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129209
Enrollment
Unknown
Registered
2026-08-01
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild congenital auricular deformities, including single or multiple morphological anomalies of the auricle, such as lop ear, macaque ear (prominent ear), cup ear, cryptotia, constricted ear, prominent ear (bat ear), helical rim deformity, and conchal crus prominence

Interventions

intervention group:Wearing a non-invasive auricular orthosis

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1.Newly diagnosed infants aged <= 120 days (4 months of age); for special types of deformities such as cryptotia, there is no strict age limit. 2.Clinically diagnosed with one or more auricular morphological deformities (definition based on the Auricular Deformity Assessment Scale). 3.Parental informed consent obtained, with written informed consent signed, and a commitment to comply with the required regular follow-up visits.

Exclusion criteria

Exclusion criteria: 1.Presence of structural auricular defects (severe deformities of Marx grade III and IV). 2.Skin lesions at the correction site, including abrasions, infections, eczema, hemangiomas, or other dermatological conditions. 3.Presence of severe systemic or unstable diseases (e.g., severe jaundice, congenital heart disease, respiratory distress, etc.). 4.Parents unable to understand the study requirements or unable to guarantee regular follow-up visits.

Design outcomes

Primary

MeasureTime frame
Satisfaction with Improvement in Auricular Morphology;Total Effective Rate;

Secondary

MeasureTime frame
Parental satisfaction evaluation:;Safety Assessment;

Countries

China

Contacts

Public ContactPeng Jiaojiao

West China Hospital of Sichuan University

102195396@qq.com+86 28 85422436

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026