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Search / Trial NCT07057258

Injection Versus Suture Repair of Laryngeal Clefts

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

Trial Information

Current as of July 24, 2025

Not yet recruiting

Keywords

Endoscopic Suture Repair Injection Laryngoplasty Pediatrics Otolaryngology Dysphagia Laryngeal Cleft

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

About Oregon Health And Science University

Oregon Health and Science University (OHSU) is a leading academic medical center dedicated to advancing health through research, education, and patient care. As a prominent sponsor of clinical trials, OHSU leverages its extensive expertise in various medical fields to facilitate innovative research aimed at improving patient outcomes. The institution is committed to ethical standards and rigorous scientific methodologies, fostering collaborations that enhance the development of new therapies and interventions. With a focus on translating research discoveries into clinical practice, OHSU plays a pivotal role in shaping the future of healthcare.

Locations

Nashville, Tennessee, United States

Portland, Oregon, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported