Examining the impact of laryngomalacia on children's quality of life before and after treatment
Laryngomalacia, Examinations and Quality of Life in Children Before and After Treatment With Follow-up After 1 Year
This study looks at how laryngomalacia affects the quality of life for children and sees if treatment, including surgery, can help them feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 1 Week to 52 Weeks |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 2 sites (Oslo and 1 other locations) |
| Trial ID | NCT06464757 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on children diagnosed with laryngomalacia, a common cause of stridor and breathing difficulties in infants. It aims to assess the impact of this condition on the quality of life of affected children before and after treatment, including surgical intervention if necessary. The study will utilize sleep examinations, such as polygraphy and polysomnography, to determine which children may benefit from surgery. Follow-up assessments will be conducted at 4-6 weeks and again after one year to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are infants and young children diagnosed with laryngomalacia and experiencing stridor or breathing difficulties.
Not a fit: Patients with breathing difficulties caused by conditions other than laryngomalacia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment decisions for children with laryngomalacia, enhancing their quality of life.
How similar studies have performed: While laryngomalacia is a well-known condition, the specific approach of using sleep examinations to guide treatment decisions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * laryngomalacia * stridor * breathing difficulties Exclusion Criteria: \- none
Where this trial is running
Oslo and 1 other locations
- Oslo University Hospital — Oslo, Norway (Recruiting)
- Lovisenberg Diaconal Hospital — Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Harriet Akre
- Email: harriet.akre@medisin.uio.no
- Phone: +4723070000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.