What is the mechanism of action of this treatment?

Common treatments for swallowing disorders include temperature modification, texture modification, and swallowing exercises. The mechanism of action for temperature modification, such as using cold liquids, involves stimulating sensory receptors in the oropharynx, which can enhance the swallowing reflex and improve coordination. This is particularly relevant for patients with dysphagia, as it can lead to more effective and safer swallowing. Understanding these mechanisms helps clinicians tailor treatments to individual needs, potentially reducing the risk of aspiration and improving overall quality of life for patients with swallowing disorders.

What side effects are associated with this type of intervention?

Common treatments for swallowing disorders, such as thermal application and radiotherapy, can have various side effects. Thermal application, while studied for its potential benefits, has not shown strong evidence of improvement and may not significantly alter the occurrence of aspiration or penetration. Radiotherapy, often used in head and neck cancer patients, can lead to moderate skin erythema, dry or moist desquamation, mucositis, dysphagia, and long-term complications like esophageal stricture and chronic dysphagia. These treatments aim to improve swallowing function but come with risks that need to be managed carefully.

What prior FDA approvals exist?

There are no specific FDA-approved treatments that directly parallel the use of cold liquid barium for improving the swallowing mechanism in dysphagia. However, various therapeutic approaches, such as modified barium swallow studies, are commonly used to assess and manage swallowing disorders. These studies help in identifying the nature of the swallowing difficulty and guide the development of individualized treatment plans, which may include dietary modifications, swallowing exercises, and sensory enhancement techniques. While cold liquid barium has shown promise in improving swallowing in preterm infants with dysphagia, further research is needed to establish its efficacy and safety for broader clinical use.

What other types of research exist?

Promising novel alternatives to cold liquid barium for treating swallowing disorders include thermal application techniques, such as thermal stimulation, which have been studied for their effects on dysphagia. Additionally, endoscopic and surgical interventions like endoscopic pyloromyotomy (G-POEM) and laparoscopic pyloroplasty, although primarily used for gastroparesis, may offer insights into novel approaches for managing swallowing disorders. Further research and clinical trials are needed to establish their efficacy specifically for dysphagia.

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Cold Liquid Barium for Swallowing Disorders in Preterm Infants

N/A

Waitlist Available

Led By Nazeeh Hanna, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be younger than 18 years old

Must not have

Infants born prematurely with a corrected gestational age of 43 weeks or greater.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up <5 seconds post swallow trigger

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether giving preterm babies with swallowing difficulties a cold liquid can help them swallow better. The cold liquid might make their throats more sensitive, which could improve their ability to swallow. The study will also check if this method is safe for the babies. Cold stimulation has been shown to reduce airway compromise in adults with swallowing difficulties, but there is no sufficient evidence to support its use in children.

Who is the study for?

This trial is for preterm infants born before 37 weeks who are suspected to have swallowing difficulties (dysphagia) and are referred for a swallow study. Infants over a corrected age of 43 weeks or with other health issues that could affect the study's results cannot participate.

What is being tested?

The study tests if feeding cold liquid barium to preterm infants with dysphagia helps them swallow better than room temperature liquids. It measures changes in their swallowing mechanism using special X-ray videos called videofluoroscopic swallow studies, taken at different times during a 10-minute feeding period.

What are the potential side effects?

While specific side effects aren't listed, the trial will monitor safety by checking the infant's body and stomach temperatures to ensure they don't develop cold stress from the cold liquid.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My baby was born early and is suspected to have swallowing problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My baby was born early but is now older than 43 weeks corrected age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ <5 seconds post swallow trigger

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~<5 seconds post swallow trigger

This trial's timeline: 3 weeks for screening, Varies for treatment, and <5 seconds post swallow trigger for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pharyngeal Phase Dysphagia

Secondary study objectives

Laryngeal Penetration

Nasopharyngeal Reflux

Pharyngeal residue

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Cold Liquid Swallows- 5Experimental Treatment1 Intervention

Immediately following the RTS condition, a total of 5 swallows of Cold Liquid Barium was observed under fluoroscopy from an identical bottle and nipple. Images were saved electronically and labeled "CS5" for "cold swallows-5."

Group II: Cold Liquid Swallows- 10Experimental Treatment1 Intervention

After 10 minutes of feeding a cold liquid, a total of 10 swallows of Cold Liquid Barium was observed under fluoroscopy from an identical bottle and nipple. Images were saved electronically and labeled "CS10" for "cold swallows-10."

Group III: Room Temperature SwallowsActive Control1 Intervention

Once consented, each participant underwent a video fluoroscopic swallow study (VFSS). Each participant was fed room temperature thin liquid barium (Varibar® Thin Liquid Barium Sulfate for Suspension) from a standard bottle (60ml Similac® Volu-Feeder®) with an attached Similac® Infant Nipple and Ring. The swallows were assessed in real time for any swallowing dysfunction and saved electronically. These swallows were labeled "RTS" for "room temperature swallows. If no swallow dysfunction was observed, the participant became ineligible and the study ended. If swallow dysfunction was observed, the participant became eligible to complete the other arms of the study.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for swallowing disorders include temperature modification, texture modification, and swallowing exercises. The mechanism of action for temperature modification, such as using cold liquids, involves stimulating sensory receptors in the oropharynx, which can enhance the swallowing reflex and improve coordination. This is particularly relevant for patients with dysphagia, as it can lead to more effective and safer swallowing. Understanding these mechanisms helps clinicians tailor treatments to individual needs, potentially reducing the risk of aspiration and improving overall quality of life for patients with swallowing disorders.

[Treatment and rehabilitation of dysphagia following cerebrovascular disease].