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NCT02935946 · ClinicalTrials.gov registry record · NA
Cold Liquids Fed to Preterm Infants: Efficacy and Safety After 10 Minutes of Exposure
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 4,043
- Enrollment target
NCT02935946: Completed NA study, sponsored by NYU Langone Health.
NCT02935946 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 4,043 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (188% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02935946, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 4,043 participants
- Enrollment target
Study Summary
A previous study revealed that dysphagia preterm infants show statistically significant improvements in their swallowing mechanism when fed cold liquid barium when compared to room temperature liquid barium. The previous study was the first to identify these positive effects, although, only assessed 5 cold liquid swallows, immediately after the room temperature condition. This limited data set restricts the efficacy and safety of using cold liquids in clinical practice, emphasizing the need for further information. The present study aims to objectively assess the influence of cold liquid on the pharyngeal swallow mechanism in preterm infants with dysphagia after 10 minutes of a cold liquid feeding. The investigators will utilize videofluoroscopic swallow studies (VFSS) to analyze the frequency and severity of pharyngeal swallowing deficits during room temperature swallows and compare it to cold liquid swallows at various time points within a 10 minute feeding. Safety measures will also be obtained, such as participant axillary body temperature and gastric content temperature, to identify indicators for the development of cold stress.
Primary Outcome
presence of atypical or disordered movements during the pharyngeal phase of swallowing
Interventions
- OTHER Cold Liquid Barium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,043 participants |
| Start Date | 2016-10 |
| Est. Completion | 2024-03-17 |
| Phase | NA |
What the finished NCT02935946 record still lists
NCT02935946 is an interventional study that assigns participants to a tested intervention. Its 4,043 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (188% higher).
The record links to 0 conditions, and to 1 intervention - of which Cold Liquid Barium is the first listed.
NCT02935946 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02935946 about?
NCT02935946 is a clinical study titled "Cold Liquids Fed to Preterm Infants: Efficacy and Safety After 10 Minutes of Exposure". A previous study revealed that dysphagia preterm infants show statistically significant improvements in their swallowing mechanism when fed cold liquid barium when compared to room temperature liquid barium. The previous study was the first to identify these positive effects, although, only assessed...
What is the current status of trial NCT02935946?
This trial is currently completed. It is a NA study. The enrollment target is 4,043 participants. The study started on 2016-10. Estimated completion is 2024-03-17.
What interventions are being tested in trial NCT02935946?
The interventions under investigation include: Cold Liquid Barium (OTHER).
Who is sponsoring clinical trial NCT02935946?
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 NCT02935946's enrollment target sits among peer trials
4,043 32nd of 2000 higher than 1,969 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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