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

NCT02003287 | Completed

• 1 other identifier: 012-282
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Deglutition Disorders

Keywords

Deglutition Disorders; Intensive Care Units, Neonatal

Outcome Measures

Primary Outcomes (1)

• High sensitivity and specificity values for FEES

  one year

Secondary Outcomes (1)

• Evidence of laryngeal penetration or tracheal aspiration during breastfeeding

  at time of assessment

Study Arms (2)

FEES

EXPERIMENTAL

Swallowing evaluation with the Fiberoptic Endoscopic Evaluation of Swallowing

Other: FEES

VFSS

ACTIVE COMPARATOR

Swallowing evaluation with the Videofluoroscopic Swallowing Study

Other: VFSS

Interventions

VFSS OTHER

Videofluoroscopic Swallow Study

VFSS

FEES OTHER

Fiberoptic Endoscopic Swallow Study

FEES

Eligibility Criteria

• Age: 37 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not medically stable enough to undergo both FEES and VFSS as determined by neonatal therapist and/or physician
• Bilateral complete cleft lip and palate

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Related Publications (3)

• da Silva AP, Lubianca Neto JF, Santoro PP. Comparison between videofluoroscopy and endoscopic evaluation of swallowing for the diagnosis of dysphagia in children. Otolaryngol Head Neck Surg. 2010 Aug;143(2):204-9. doi: 10.1016/j.otohns.2010.03.027.

  PMID: 20647120 BACKGROUND

• Leder SB, Karas DE. Fiberoptic endoscopic evaluation of swallowing in the pediatric population. Laryngoscope. 2000 Jul;110(7):1132-6. doi: 10.1097/00005537-200007000-00012.

  PMID: 10892683 BACKGROUND

• Suterwala MS, Reynolds J, Carroll S, Sturdivant C, Armstrong ES. Using fiberoptic endoscopic evaluation of swallowing to detect laryngeal penetration and aspiration in infants in the neonatal intensive care unit. J Perinatol. 2017 Apr;37(4):404-408. doi: 10.1038/jp.2016.239. Epub 2017 Jan 5.

  PMID: 28055025 DERIVED

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Fees and Charges

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Officials

• Mustafa S. Suterwala, M.D.

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 6, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

US (1)