Injection Versus Suture Repair of Laryngeal Clefts

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · Jun 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different procedures to help children who have trouble swallowing because of a condition called a laryngeal cleft, where food or liquid can accidentally go into the airway. The study wants to find out if injecting a gel (injection laryngoplasty) or using stitches to repair the airway (endoscopic suture repair) works better to improve swallowing and prevent food or liquid from going down the wrong way.

The trial is for children aged 1 to 10 years old who have been referred to a special clinic because they show signs of swallowing problems on a specific swallowing test and have already tried thickened liquids without enough improvement. Children with certain other health issues, like cerebral palsy or those who have had a feeding tube for most of their nutrition, are not eligible. If a child joins, they will have tests before and three months after the procedure, including a special X-ray study where they swallow foods and drinks with a safe dye to see how swallowing is working. Parents will also be asked to fill out questionnaires about their child’s swallowing before and after the treatment. This study is not yet enrolling participants but aims to help families and doctors understand which procedure might be best for improving swallowing in children with this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • children aged 12 months - 10 years referred to a multi-disciplinary aerodigestive clinic with evidence of penetration or aspiration on VFSS, requiring any amount of thickening of liquids and unable to wean after 2-month trial of thickened liquids.
• Exclusion Criteria:
• • Cerebral palsy
• • Down syndrome
• • Prematurity \< 28 weeks gestational age
• • Hypoxic brain injury
• • Any syndrome with significant hypotonia
• • History of nothing by mouth (NPO) for \> 1 month prior to assessment
• • \>50% of nutrition by G-tube
• • Tracheostomy
• • History of prior IL or ER