Ear mold for congenital ear malformation

Ear mold for congenital ear malformation: a randomised controlled trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000031052

Enrollment

Unknown

Registered

2020-03-21

Start date

2020-05-01

Completion date

Unknown

Last updated

2020-08-24

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

Conditions

congenital ear malformation

Interventions

experimental group:Ear mold treatment starts within 3 days old for 2 weeks

control group:Observation through 6 weeks, receive ear moulding treatment if not naturally recovery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 0-7 day newborn; 2) with diagnosis of ear malformation, including prominent ear, Stahl's ear, top ear, cup ear, cryptotia, conchal crus, helical rim deformity or mixed ear deformity, with Microtia (Marx I).

Exclusion criteria

Exclusion criteria: 1) low birth weight (<2500 g); 2) accompanied with multiple organ malformations; 3) with acute dermatitis; 4) allergic constitution or other health issure not suitable for inclusin in the study.

Design outcomes

Primary

Measure	Time frame
Clinician evaluated improvement (Binary);	—

Secondary

Measure	Time frame
Parent evaluated improvement;Parent's depression and anxiety;Parent's quality of life;	—

Countries

China

Contacts

Public ContactLi Zhao

West China Center of Medical Sciences, Sichuan University

zhaoli@scu.edu.cn+86 13688060998

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026