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NCT02003287 Clinical Trial

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
Secondary ID
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

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
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