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OpenTrials
Completed

NCT Number: NCT02003287

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

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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Key information

Conditions

Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

37 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VFSS

Other

Videofluoroscopic Swallow Study

FEES

Other

Fiberoptic Endoscopic Swallow Study

Primary outcomes

  1. High sensitivity and specificity values for FEES

    Time frame: one year

Secondary outcomes

  1. Evidence of laryngeal penetration or tracheal aspiration during breastfeeding

    Time frame: at time of assessment

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2013
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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