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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 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 4,043 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02935946
The ClinicalTrials.gov registry entry for NCT02935946 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 4,043 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cold Liquid Barium is the first listed.
NCT02935946 reports 0 study locations.
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.
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