Dysphagia Clinical Trial
Official title:
A Pilot Study on The Effects of Cold Liquids on the Pharyngeal Swallow in Preterm Infants With Dysphagia.
NCT number | NCT01863264 |
Other study ID # | 460111-3 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2013 |
Est. completion date | December 2015 |
Verified date | February 2019 |
Source | New York University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to see if cold liquids improve the swallowing mechanisms in premature infants with swallowing difficulties (dysphagia). The only way to objectively diagnose dysphagia is by having that infant undergo a Video Fluoroscopic Swallow Study (VFSS), which allows direct visualization of the liquid bolus (barium) in real time. Infants suspected of having dysphagia and who are referred for a VFSS will be recruited for this study. Once consented, the infant will undergo a standard VFSS. If that infant is diagnosed with dysphagia, the study protocol will begin by keeping the infant the same position and feeding them cold liquid barium from an identical bottle. A total of 5 swallows will be visualized, which adds approximately 5-10 seconds to the study. Both the standard swallows and the study swallows will be recorded for analysis and comparison. It is hypothesized that the study swallows will have less deficits than the standard swallows. If an infant's standard VFSS does not indicate dysphagia, that infant will no longer be eligible for this study.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 43 Weeks |
Eligibility |
Inclusion Criteria: - Infants born prematurely, as defined by birth at less than 37 weeks gestational age, referred for a videofluoroscopic swallow study (VFSS) due to suspected pharyngeal phase dysphagia. Exclusion Criteria: - Infants born prematurely with a corrected gestational age of 43 weeks or greater. |
Country | Name | City | State |
---|---|---|---|
United States | Winthrop University Hospital | Mineola | New York |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharyngeal Swallow Trigger | the interval in seconds between the first frame showing barium passing the posterior tongue to the first frame showing laryngeal elevation. | <2seconds post swallow trigger | |
Primary | Laryngeal Penetration, Mild | the occurrence of barium underneath the epiglottis, remaining in the upper 1/3 quadrant of the laryngeal vestibule | <2 seconds post swallow trigger | |
Primary | Laryngeal Penetration, Deep | the occurrence of barium underneath the epiglottis, in the laryngeal vestibule to the level of the vocal folds | <2 seconds post swallow trigger | |
Primary | Tracheal Aspiration | the occurrence of barium below the level of the true vocal cords | <5 seconds post swallow trigger | |
Primary | Nasopharyngeal Reflux | the occurrence of barium detected in the nasopharynx, posterior or superior to the velum | <2 seconds post swallow trigger | |
Secondary | Pharyngeal residue | the presence of residual barium coating the pharyngeal walls, pooling in the vallecula or pyriform sinuses post swallow (absent/mild/severe). | <5 seconds post swallow trigger | |
Secondary | Silent Aspiration | occurrence of a cough in the presence of aspiration (present/absent) | <5 seconds post swallow trigger | |
Secondary | Laryngeal Clearance | ability to clear larynx during penetration events (sufficient/insufficient) | <5 seconds post swallow trigger | |
Secondary | Tracheal Clearance | ability to clear trachea during aspiration events (sufficient/insufficient) | <5 seconds post swallow trigger |
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