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

Deglutition Disorders Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003287
• Other study ID #: 012-282
• Status: Completed
• Phase: N/A
• First received: December 3, 2013
• Last updated: March 5, 2015
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 37 Weeks and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Deglutition Disorders

Intervention

Other:
• VFSS
Videofluoroscopic Swallow Study
• FEES
Fiberoptic Endoscopic Swallow Study

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Leder SB, Karas DE. Fiberoptic endoscopic evaluation of swallowing in the pediatric population. Laryngoscope. 2000 Jul;110(7):1132-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High sensitivity and specificity values for FEES		one year	No
Secondary	Evidence of laryngeal penetration or tracheal aspiration during breastfeeding		at time of assessment	No