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Laryngeal Disorders After Childhood Cardiac Surgery

NCT04638361 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2022-11-28

No results posted yet for this study

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

  • Laryngeal Injury
  • Swallowing Disorder
  • Voice Disorders in Children
  • Surgery--Complications

Interventions

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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Sonia AYARI-KHALFALLAH, MD · Hôpital Femme Mère Enfant - Department of ENT Pediatric surgery,

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-26
Primary Completion
2021-09-17
Completion
2021-09-17

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04638361 on ClinicalTrials.gov