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Comparing FEES to VFSS in Diagnosing Laryngeal Penetration and Aspiration in Infants in the NICU

Primary Purpose

Deglutition Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VFSS
FEES
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Deglutition Disorders focused on measuring Deglutition Disorders, Intensive Care Units, Neonatal

Eligibility Criteria

37 Weeks - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 37 weeks or more postmenstrual age
  • Diagnosis or suspicion of laryngeal penetration and/or tracheal aspiration by neonatal therapist and/or physician
  • Inpatient at Baylor University Medical Center NICU

Exclusion Criteria:

  • Not medically stable enough to undergo both FEES and VFSS as determined by neonatal therapist and/or physician
  • Bilateral complete cleft lip and palate

Sites / Locations

  • Baylor University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FEES

VFSS

Arm Description

Swallowing evaluation with the Fiberoptic Endoscopic Evaluation of Swallowing

Swallowing evaluation with the Videofluoroscopic Swallowing Study

Outcomes

Primary Outcome Measures

High sensitivity and specificity values for FEES

Secondary Outcome Measures

Evidence of laryngeal penetration or tracheal aspiration during breastfeeding

Full Information

First Posted
December 3, 2013
Last Updated
March 5, 2015
Sponsor
Baylor Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02003287
Brief Title
Comparing FEES to VFSS in Diagnosing Laryngeal Penetration and Aspiration in Infants in the NICU
Official Title
Determining the Efficacy of Using FEES Compared to VFSS to Diagnose Laryngeal Penetration and Aspiration in Infants in the Neonatal Intensive Care Unit (NICU)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of the study is to determine whether the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) is effective in detecting laryngeal penetration and tracheal aspiration when compared with the Videofluoroscopic Swallowing Study (VFSS) in bottle-feeding infants in the NICU. A secondary objective is to determine whether FEES can be used to detect laryngeal penetration and tracheal aspiration in breastfeeding NICU infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition Disorders
Keywords
Deglutition Disorders, Intensive Care Units, Neonatal

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FEES
Arm Type
Experimental
Arm Description
Swallowing evaluation with the Fiberoptic Endoscopic Evaluation of Swallowing
Arm Title
VFSS
Arm Type
Active Comparator
Arm Description
Swallowing evaluation with the Videofluoroscopic Swallowing Study
Intervention Type
Other
Intervention Name(s)
VFSS
Intervention Description
Videofluoroscopic Swallow Study
Intervention Type
Other
Intervention Name(s)
FEES
Intervention Description
Fiberoptic Endoscopic Swallow Study
Primary Outcome Measure Information:
Title
High sensitivity and specificity values for FEES
Time Frame
one year
Secondary Outcome Measure Information:
Title
Evidence of laryngeal penetration or tracheal aspiration during breastfeeding
Time Frame
at time of assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 37 weeks or more postmenstrual age Diagnosis or suspicion of laryngeal penetration and/or tracheal aspiration by neonatal therapist and/or physician Inpatient at Baylor University Medical Center NICU Exclusion Criteria: Not medically stable enough to undergo both FEES and VFSS as determined by neonatal therapist and/or physician Bilateral complete cleft lip and palate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa S. Suterwala, M.D.
Organizational Affiliation
Baylor Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20647120
Citation
da Silva AP, Lubianca Neto JF, Santoro PP. Comparison between videofluoroscopy and endoscopic evaluation of swallowing for the diagnosis of dysphagia in children. Otolaryngol Head Neck Surg. 2010 Aug;143(2):204-9. doi: 10.1016/j.otohns.2010.03.027.
Results Reference
background
PubMed Identifier
10892683
Citation
Leder SB, Karas DE. Fiberoptic endoscopic evaluation of swallowing in the pediatric population. Laryngoscope. 2000 Jul;110(7):1132-6. doi: 10.1097/00005537-200007000-00012.
Results Reference
background
PubMed Identifier
28055025
Citation
Suterwala MS, Reynolds J, Carroll S, Sturdivant C, Armstrong ES. Using fiberoptic endoscopic evaluation of swallowing to detect laryngeal penetration and aspiration in infants in the neonatal intensive care unit. J Perinatol. 2017 Apr;37(4):404-408. doi: 10.1038/jp.2016.239. Epub 2017 Jan 5.
Results Reference
derived

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Comparing FEES to VFSS in Diagnosing Laryngeal Penetration and Aspiration in Infants in the NICU

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