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NCT04638361 Clinical Trial

Laryngeal Disorders After Childhood Cardiac Surgery

Surgery--Complications Clinical Trial

— RECUP-TML  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04638361
Other study ID # 69HCL20_0505
Secondary ID 2020-A01701-38
Status Completed
Phase
First received
Last updated
Start date August 26, 2021
Est. completion date September 17, 2021

Study information
Verified date November 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date September 17, 2021
Est. primary completion date September 17, 2021
Accepts healthy volunteers No
Gender All
Age group 5 Years to 10 Years
Eligibility Inclusion Criteria: - No opposition from children and parents - Patient or parents able to understand the ins and outs of the study Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaires
To 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.

Locations
Country Name City State
France Hôpital Femme Mère Enfant Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of a laryngeal mobility disorder after childhood cardiac surgery The prevalence will be evaluated on the respiratory, food or phonatory difficulties reported after surgery as well as on the result of early postoperative nasofibroscopy. One day
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