Clinical trialNCT02935946CompletedInterventional

Cold Liquids Fed to Preterm Infants: Efficacy and Safety After 10 Minutes of Exposure

SponsorNYU Langone HealthEnrollment4,043Deglutition DisordersRespiratory Aspiration

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Nazeeh Hanna, MD
NYU Winthrop Hospital
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Winthrop University Hospital
Mineola, New York, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Oct 2016
Primary completion: 17 Mar 2024
Completion: 17 Mar 2024
Last update posted: 24 Jun 2024
Registered enrollment: 4,043
Registry id: NCT02935946

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.