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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up <5 seconds post swallow trigger
Awards & highlights
Study Summary
This trial will assess the safety and efficacy of cold liquid barium for treating dysphagia in preterm infants.
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.Check my eligibility
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.See study design
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 belowSelect...
My baby was born early and is suspected to have swallowing problems.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pharyngeal Phase Dysphagia
Secondary outcome measures
Laryngeal Penetration
Nasopharyngeal Reflux
Pharyngeal residue
+1 moreTrial 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.
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,370 Previous Clinical Trials
840,764 Total Patients Enrolled
Adelphi UniversityOTHER
5 Previous Clinical Trials
1,886 Total Patients Enrolled
Nazeeh Hanna, MDPrincipal InvestigatorNYU Winthrop Hospital
2 Previous Clinical Trials
27 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My baby was born early but is now older than 43 weeks corrected age.My baby was born early and is suspected to have swallowing problems.
Research Study Groups:
This trial has the following groups:- Group 1: Cold Liquid Swallows- 10
- Group 2: Cold Liquid Swallows- 5
- Group 3: Room Temperature Swallows
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
May I submit my candidacy for this clinical trial?
"This clinical trial focuses on individuals with esophageal dysphagia and a gestational age between 36 weeks to 43 weeks, with 40 participants accepted."
Answered by AI
Are there still openings to participate in this study?
"This study, which was first announced on October 1st 2016 and last updated on March 7th 2022 is no longer recruiting interested parties. Nevertheless, there are an abundance of other medical initiatives currently enrolling volunteers."
Answered by AI
Does this research study accept participants who are 55 or older?
"Patients included in this medical trial must be between 36 and 43 weeks of age. Young people under 18 have 21 clinical trials to choose from, while seniors above 65 are eligible for 143 different studies."
Answered by AI
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