Cold Liquids Fed to Preterm Infants: Efficacy and Safety After 10 Minutes of Exposure
Completed · Not applicable
Conditions studied: Deglutition Disorders, Respiratory Aspiration
In brief
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.
Key facts
- Study ID
- NCT02935946
- Run by
- NYU Langone Health
- People needed
- 4043
- Starts
- 2016-10-01
- Expected to finish
- 2024-03-17
- Last updated by the study team
- 2024-06-24
Who can join
Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Infants born prematurely with a corrected gestational age of 43 weeks or greater.
Where it is running
- Winthrop University Hospital — Mineola, New York, United States
Full record on ClinicalTrials.gov
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