Clinical Trials Directory

Trials / Completed

CompletedNCT04638361

Laryngeal Disorders After Childhood Cardiac Surgery

Prevalence of Laryngeal Disorders After Childhood Cardiac Surgery and Evaluation of Their Long-term Recovery

Status
Completed
Phase
Study type
Observational
Enrollment
14 (actual)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
5 Years – 10 Years
Healthy volunteers
Not accepted

Summary

Laryngeal disorders after childhood cardiac surgery is a complication well described in the literature. However, the long term progression of the affected children has never been studied (all the studies stopped before 2 years of follow up).

Conditions

Interventions

TypeNameDescription
OTHERQuestionnairesTo explore the quality of life, two questionnaires will be submitted to the parents and the child. The first one is the pediatric version of the VHI (Voice Handicap Index), which explore, using 23 items, the functional, physical and emotional aspects of the dysphonia. The second one is the PEDI-EAT-10 (Pediatric Voice Handicap Index - Eating Assessment Tool), which explore, through 10 items (ranging from 0 to 4), the risk of aspiration and assess the impact of possible dysphagia on quality of life.

Timeline

Start date
2021-08-26
Primary completion
2021-09-17
Completion
2021-09-17
First posted
2020-11-20
Last updated
2022-11-28

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04638361. Inclusion in this directory is not an endorsement.