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

Determining the Efficacy of Using FEES Compared to VFSS to Diagnose Laryngeal Penetration and Aspiration in Infants in the Neonatal Intensive Care Unit (NICU)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02003287

Enrollment

Registered

2013-12-06

Start date

2013-11-30

Completion date

2014-10-31

Last updated

2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deglutition Disorders

Keywords

Deglutition Disorders, Intensive Care Units, Neonatal

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.

Interventions

OTHERVFSS

Videofluoroscopic Swallow Study

OTHERFEES

Fiberoptic Endoscopic Swallow Study

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

37 Weeks to No maximum

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

Design outcomes

Primary

Measure	Time frame
High sensitivity and specificity values for FEES	one year

Secondary

Measure	Time frame
Evidence of laryngeal penetration or tracheal aspiration during breastfeeding	at time of assessment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026