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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Deglutition Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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FEES

Swallowing evaluation with the Fiberoptic Endoscopic Evaluation of Swallowing

Group Type EXPERIMENTAL

FEES

Intervention Type OTHER

Fiberoptic Endoscopic Swallow Study

VFSS

Swallowing evaluation with the Videofluoroscopic Swallowing Study

Group Type ACTIVE_COMPARATOR

VFSS

Intervention Type OTHER

Videofluoroscopic Swallow Study

Interventions

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VFSS

Videofluoroscopic Swallow Study

Intervention Type OTHER

FEES

Fiberoptic Endoscopic Swallow Study

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No