Clinical trial NCT03882450: Universal Screening for Vocal Fold Motion Impairment in Children Undergoing Congenital Cardiac Surgery
Official title: Universal Screening for Vocal Fold Motion Impairment in Children Undergoing Congenital Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vocal Fold Palsy
Dysphagia
Congenital Heart Disease in Children
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 94
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative length of stay (retrospective)
timeFrame: Baseline
measure: Number of readmissions related to feeding difficulty (retrospective)
timeFrame: Baseline
measure: Number of readmissions related to aspiration (retrospective)
timeFrame: Baseline
measure: Time to initiation of feeding therapy (retrospective)
timeFrame: Baseline
measure: Number of participants with vocal fold motion impairment (prospective)
timeFrame: Baseline
measure: Postoperative length of stay (prospective)
timeFrame: Up to 180 days
measure: Time to initiation of feeding therapy (prospective)
timeFrame: Day 7
measure: Number of readmissions related to aspiration (prospective)
timeFrame: 3 months, 6 months, 12 months
measure: Number of readmissions related to feeding difficulty (prospective)
timeFrame: 3 months, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Nikhila Raol, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: