Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-01-01 @ 7:43 AM
Study NCT ID:
NCT03882450
Status:
COMPLETED
Last Update Posted:
2020-04-14
First Post:
2019-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Universal Screening for Vocal Fold Motion Impairment in Children Undergoing Congenital Cardiac Surgery
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Universal Screening for Vocal Fold Motion Impairment in Children Undergoing Congenital Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine how often heart or chest surgery in children leads to problems with the movement of the vocal folds.
Detailed Description:
Pediatric vocal fold motion impairment (VFMI) is a well-known cause of dysphonia and dysphagia. Previous studies have demonstrated the most common etiology for pediatric VFMI is cardiothoracic surgery which is possibly due to a variety of mechanisms.The investigators hypothesize that universal screening of neonates for VMFI following congenital cardiac surgery (CCS) will lead to a more accurate incidence and earlier diagnosis of VFMI. They believe that earlier identification will lead to changes in feeding regimens that may decrease length of stay (LOS), decrease time to oral feeding, earlier otolaryngologic intervention if indicated, and decreased rates of readmission for pulmonary or feeding complications. The investigators will also use this information to design a refined algorithm for targeted screening of patients who are more likely to have VFMI based on patient and surgery characteristics.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: