NCT03882450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

1.2 years

First QC Date

March 8, 2019

Last Update Submit

April 10, 2020

Conditions

Vocal Fold PalsyDysphagiaCongenital Heart Disease in Children

Outcome Measures

Primary Outcomes (9)

  • Postoperative length of stay (retrospective)

    The number of days of postoperative stay in the hospital will be compiled by reviewing the medical records of all children 18 and under who underwent CCS (as defined by ICD-9-CM congenital heart disease procedure codes) from January 1, 2011 to December 31, 2016.

    Baseline

  • Number of readmissions related to feeding difficulty (retrospective)

    The number of readmissions to the hospital for feeding difficulties will be compiled by reviewing the medical records of all children 18 and under who underwent CCS (as defined by ICD-9-CM congenital heart disease procedure codes) from January 1, 2011 to December 31, 2016.

    Baseline

  • Number of readmissions related to aspiration (retrospective)

    The number of readmissions to the hospital for aspiration will be compiled by reviewing the medical records of all children 18 and under who underwent CCS (as defined by ICD-9-CM congenital heart disease procedure codes) from January 1, 2011 to December 31, 2016.

    Baseline

  • Time to initiation of feeding therapy (retrospective)

    The average time (in days) to start feeding therapy will be compiled by reviewing the medical records of all children 18 and under who underwent CCS (as defined by ICD-9-CM congenital heart disease procedure codes) from January 1, 2011 to December 31, 2016.

    Baseline

  • Number of participants with vocal fold motion impairment (prospective)

    The number of study participants diagnosed with VFMI following CCS universal screening will be recorded.

    Baseline

  • Postoperative length of stay (prospective)

    The number of days of postoperative stay at the hospital will be recorded.

    Up to 180 days

  • Time to initiation of feeding therapy (prospective)

    The number of days to start feeding therapy will be recorded.

    Day 7

  • Number of readmissions related to aspiration (prospective)

    The number of readmissions to the hospital for aspiration will be recorded.

    3 months, 6 months, 12 months

  • Number of readmissions related to feeding difficulty (prospective)

    The number of readmissions to the hospital for feeding difficulties will be recorded.

    3 months, 6 months, 12 months

Study Arms (2)

Neonates with congenital cardiac disease (retrospective)

NO INTERVENTION

Medical records of all children 18 and under who underwent CCS (as defined by ICD-9-CM congenital heart disease procedure codes) from January 1, 2011 to December 31, 2016 will be reviewed. Those who developed VFMI following CCS as diagnosed on flexible fiberoptic laryngoscopy will be identified. Inpatient, outpatient and emergency department (ED) records will be studied for details on postoperative length of stay, time to diagnosis of VFMI, time to initiation of oral feeding, ED visits and readmissions for feeding/weight gain or respiratory issues, and otolaryngology intervention.

Neonates with congenital cardiac disease (prospective)

ACTIVE COMPARATOR

Eligible children with known congenital cardiac disease necessitating cardiothoracic surgery will undergo universal screening, i.e., laryngeal ultrasonography and flexible fiberoptic laryngoscopy with examination and video documentation of laryngeal function preoperatively (if they are not intubated and are stable enough to do so) and postoperatively with a 2.4mm flexible laryngoscope and portable ultrasound system while awake.

Procedure: Flexible fiberoptic laryngoscopyProcedure: Laryngeal ultrasonography

Interventions

Flexible fiberoptic laryngoscopyPROCEDURE

Flexible fiberoptic laryngoscopy with examination and video documentation of laryngeal function preoperatively (if the participant is not intubated and is stable enough to do so) and postoperatively with a 2.4mm flexible laryngoscope will be performed.

Neonates with congenital cardiac disease (prospective)
Laryngeal ultrasonographyPROCEDURE

Laryngeal ultrasonography will be performed using a portable ultrasound system while the participants are awake.

Neonates with congenital cardiac disease (prospective)

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Vocal Cord ParalysisDeglutition Disorders

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVagus Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal Diseases

Study Officials

  • Nikhila Raol, MD, MPH

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 20, 2019

Study Start

January 1, 2019

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

April 14, 2020

Record last verified: 2020-04

Locations

US(1)