Universal Screening for Vocal Fold Motion Impairment in Children Undergoing Congenital Cardiac Surgery



Status:Enrolling by invitation
Conditions:Cardiology, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology
Healthy:No
Age Range:Any - 18
Updated:3/22/2019
Start Date:January 1, 2019
End Date:April 30, 2020

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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.

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.

Inclusion Criteria:

- Children 18 and younger with congenital cardiac disease necessitating surgery

- Children 18 and younger whose parents have given and signed an informed consent and
HIPAA Authorization as well as the assent of the patient

Exclusion Criteria:

- History of prior cardiac surgery

- Known history of VFMI prior to evaluation

- Children 18 and younger who do not survive the immediate postoperative course will be
excluded.

- Further exclusion may be determined at the discretion of the Principal Investigator.
We found this trial at
1
site
1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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