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Ear mold for congenital ear malformation: A randomized controlled trial
Kun Zou1,2, Yanjun Fan3, Lihua Jiang4
1Department of Health Policy and Management.
Insights
Early ear molding is effective and safe for treating congenital auricular deformities (CAD) in newborns. This randomized controlled trial provides evidence to guide clinical decisions for CAD treatments.
Area of Science:
- Pediatric Plastic Surgery
- Neonatal Care
- Medical Device Technology
Background:
- Congenital auricular deformities (CAD) are common birth defects.
- Early intervention is crucial for managing CAD.
- Current treatment guidelines for CAD require further evidence.
Purpose of the Study:
- To evaluate the efficacy and safety of ear molding for CAD in newborns.
- To compare ear molding with a waiting list approach for CAD treatment.
- To assess the impact of ear molding on parental anxiety and quality of life.
Main Methods:
- A randomized controlled trial involving 190 infants under 3 days old with CAD.
- Infants were assigned to either immediate ear molding (treatment group) or a waiting list (control group).
- Outcomes including recovery rate, parental anxiety, depression, and quality of life were assessed at multiple time points.
Main Results:
- The study aims to compare the recovery rate between the ear molding and waiting list groups.
- Secondary outcomes such as parental psychological well-being and adverse events will be analyzed.
- Statistical analysis will utilize Chi-square tests and analysis of variance.
Conclusions:
- This is the first randomized controlled trial investigating the effectiveness, safety, and cost-effectiveness of ear molding for CAD.
- Findings will inform clinical decision-making for CAD treatments.
- Results will contribute to the development of relevant clinical guidelines for managing CAD.
Background:
Congenital auricular deformities (CAD) are prevalent worldwide. The objective of this study is to investigate the effectiveness and safety of ear molding for children with CAD at their early days.
Methods:
One hundred and nighty children (under 3 days) with CAD will be included in the study. Participants will be randomly allocated to treatment or waiting list group (n = 95). The treatment group will receive ear molding within 3 days after birth for 2 weeks. The control group will receive usual care and receive the same ear molding at 6th week if spontaneously recover is not occur. Physician and parent assessment of improvement, parent's anxiety, depression, and quality of life and adverse events will be measured at baseline, 3rd and 6th week of initial treatment. The primary outcome recovery rate will be compared between groups using Chi square test. Secondary continuous outcomes will be compared using analysis of variance.
Discussion:
This study is the first randomized controlled trial to examine the effectiveness, safety and cost-effectiveness of ear molding for CAD comparing with waiting list, to inform clinical decision of CAD treatments and relevant guideline development.
