Comparing FEES to VFSS in Diagnosing Laryngeal Penetration and Aspiration in Infants in the NICU
Not Applicable
Completed
- Conditions
- Deglutition Disorders
- Interventions
- Other: VFSSOther: FEES
- Registration Number
- NCT02003287
- Lead Sponsor
- Baylor Research Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description VFSS VFSS Swallowing evaluation with the Videofluoroscopic Swallowing Study FEES FEES Swallowing evaluation with the Fiberoptic Endoscopic Evaluation of Swallowing
- Primary Outcome Measures
Name Time Method High sensitivity and specificity values for FEES one year
- Secondary Outcome Measures
Name Time Method Evidence of laryngeal penetration or tracheal aspiration during breastfeeding at time of assessment
Trial Locations
- Locations (1)
Baylor University Medical Center
🇺🇸Dallas, Texas, United States