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NCT01863264 · ClinicalTrials.gov registry record · NA
The Effects of Cold Liquids on the Swallowing Mechanism in Preterm Infants
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT01863264: Completed NA study, sponsored by NYU Langone Health.
NCT01863264 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01863264, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
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.
Primary Outcome
the interval in seconds between the first frame showing barium passing the posterior tongue to the first frame showing laryngeal elevation.
Interventions
- OTHER Cold Thin Liquid Barium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-12 |
| Phase | NA |
What the finished NCT01863264 record still lists
NCT01863264 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Cold Thin Liquid Barium is the first listed.
NCT01863264 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01863264 about?
NCT01863264 is a clinical study titled "The Effects of Cold Liquids on the Swallowing Mechanism in Preterm Infants". 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 visualiz...
What is the current status of trial NCT01863264?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2013-12. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01863264?
The interventions under investigation include: Cold Thin Liquid Barium (OTHER).
Who is sponsoring clinical trial NCT01863264?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01863264's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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