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

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ClinicalTrials.gov Identifier: NCT02003287
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Deglutition Disorders Other: VFSS Other: FEES Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
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)
Study Start Date : November 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FEES
Swallowing evaluation with the Fiberoptic Endoscopic Evaluation of Swallowing
Other: FEES
Fiberoptic Endoscopic Swallow Study

Active Comparator: VFSS
Swallowing evaluation with the Videofluoroscopic Swallowing Study
Other: VFSS
Videofluoroscopic Swallow Study




Primary Outcome Measures :
  1. High sensitivity and specificity values for FEES [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Evidence of laryngeal penetration or tracheal aspiration during breastfeeding [ Time Frame: at time of assessment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   37 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003287


Locations
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United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
Investigators
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Principal Investigator: Mustafa S. Suterwala, M.D. Baylor Health Care System
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT02003287    
Other Study ID Numbers: 012-282
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Keywords provided by Baylor Research Institute:
Deglutition Disorders
Intensive Care Units, Neonatal
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases