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The Effects of Cold Liquids on the Swallowing Mechanism in Preterm Infants

Primary Purpose

Dysphagia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cold Thin Liquid Barium
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dysphagia focused on measuring dysphagia, swallowing, infant, premature, neonate, thermal, cold, bolus, temperature, deglutition, NICU, bottle, nippling

Eligibility Criteria

undefined - 43 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Winthrop University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cold Thin Liquid Barium

Arm Description

Poland Spring Natural Spring Water will be placed in a refrigerator set to 36 °F, this will allow the water to cool to approximately 4-9 °C. As described by several authors, these waters will be used to mix the barium powder (Varibar® Thin Liquid Barium Sulfate for Suspension) to create a thin liquid consistency, with 50% dilution, which is found to be most similar to human milk and infant formula. the infant will be required to swallow 5 boluses of this cold liquid barium while bottle feeding.

Outcomes

Primary Outcome Measures

Pharyngeal Swallow Trigger
the interval in seconds between the first frame showing barium passing the posterior tongue to the first frame showing laryngeal elevation.
Laryngeal Penetration, Mild
the occurrence of barium underneath the epiglottis, remaining in the upper 1/3 quadrant of the laryngeal vestibule
Laryngeal Penetration, Deep
the occurrence of barium underneath the epiglottis, in the laryngeal vestibule to the level of the vocal folds
Tracheal Aspiration
the occurrence of barium below the level of the true vocal cords
Nasopharyngeal Reflux
the occurrence of barium detected in the nasopharynx, posterior or superior to the velum

Secondary Outcome Measures

Pharyngeal residue
the presence of residual barium coating the pharyngeal walls, pooling in the vallecula or pyriform sinuses post swallow (absent/mild/severe).
Silent Aspiration
occurrence of a cough in the presence of aspiration (present/absent)
Laryngeal Clearance
ability to clear larynx during penetration events (sufficient/insufficient)
Tracheal Clearance
ability to clear trachea during aspiration events (sufficient/insufficient)

Full Information

First Posted
May 22, 2013
Last Updated
February 4, 2019
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT01863264
Brief Title
The Effects of Cold Liquids on the Swallowing Mechanism in Preterm Infants
Official Title
A Pilot Study on The Effects of Cold Liquids on the Pharyngeal Swallow in Preterm Infants With Dysphagia.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to see if cold liquids improve the swallowing mechanisms in premature infants with swallowing difficulties (dysphagia). The only way to objectively diagnose dysphagia is by having that infant undergo a Video Fluoroscopic Swallow Study (VFSS), which allows direct visualization of the liquid bolus (barium) in real time. Infants suspected of having dysphagia and who are referred for a VFSS will be recruited for this study. Once consented, the infant will undergo a standard VFSS. If that infant is diagnosed with dysphagia, the study protocol will begin by keeping the infant the same position and feeding them cold liquid barium from an identical bottle. A total of 5 swallows will be visualized, which adds approximately 5-10 seconds to the study. Both the standard swallows and the study swallows will be recorded for analysis and comparison. It is hypothesized that the study swallows will have less deficits than the standard swallows. If an infant's standard VFSS does not indicate dysphagia, that infant will no longer be eligible for this study.
Detailed Description
Swallowing is a complex task that takes place in the mouth and throat. It involves tiny receptors that gather sensory information about the liquid. Those receptors send a sensory message to the brain, where it is processed. The brain then sends back motor messages to the muscles in the throat regarding what kind of motor movements to do in order to swallow that liquid safely. The motor movements must be carefully timed and coordinated to safely swallow the liquid with out it going near, or into the lungs. When the liquid goes down the wrong tube, or into the lungs, it is called aspiration. Some infants that are born prematurely end up with swallowing problems when drinking from a bottle. This problem can lead to liquid, such as formula or breastmilk, to be aspirated. This is due to the infant's poor coordination of all the muscles needed to safely swallow. Researchers have found that changing the sensory characteristics of the liquid alters the motor movements of the swallow. This is because the sensory receptors respond differently to different types if liquids. Studies using adults with swallowing problems has shown that swallowing cold liquids improves some of the swallowing difficulties. Based off of these observations, there are currently several therapies used in Neonatal Intensive Care Units (NICU) nationwide which use cold stimulation to improve swallowing in prematurely born infants, although, there has been no research studies proving it actually works. The purpose of this study is to assess the effect of cold liquid on the swallow mechanism in preterm infants with swallowing difficulties. A video x-ray procedure, called a Videofluoroscopic Swallow Study (VFSS), is considered the gold standard when assessing the motor movements present in the throat when swallowing. The standard procedure for an infant VFSS involves bottle feeding room temperature liquid barium while looking at the swallow movements obtained from the video x-ray images. After consent is obtained, infants who are assumed to have swallowing difficulties will undergo a "standard" VFSS. If during the study they are found to have swallowing problems, the study protocol will then begin by introducing cold liquid barium from an identical bottle. A total of 5 swallows will be looked at and recorded for review at a later time. The standard procedure for that infant's VFSS will then continue. The hypothesis is that cold liquids will improve the swallowing movements in premature infants with swallowing difficulty. Information gathered will support the use of cold liquids and cold stimulation in NICUs to help benefit these infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
dysphagia, swallowing, infant, premature, neonate, thermal, cold, bolus, temperature, deglutition, NICU, bottle, nippling

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cold Thin Liquid Barium
Arm Type
Experimental
Arm Description
Poland Spring Natural Spring Water will be placed in a refrigerator set to 36 °F, this will allow the water to cool to approximately 4-9 °C. As described by several authors, these waters will be used to mix the barium powder (Varibar® Thin Liquid Barium Sulfate for Suspension) to create a thin liquid consistency, with 50% dilution, which is found to be most similar to human milk and infant formula. the infant will be required to swallow 5 boluses of this cold liquid barium while bottle feeding.
Intervention Type
Other
Intervention Name(s)
Cold Thin Liquid Barium
Other Intervention Name(s)
Varibar® Thin Liquid Barium Sulfate for Suspension
Intervention Description
Cold thin liquid barium will be fed to the participant from a standard bottle (60ml Similac® Volu-Feeder® with an attached Similac® Infant Nipple and Ring (standard flow)). For this study the refrigerated (cold) thin liquid barium will be measured for an exact temperature of 4-9°C prior to administration to control for any temperature variation. A total of 5 swallows will be visualized and saved electronically on the hospital's electronic storage system.
Primary Outcome Measure Information:
Title
Pharyngeal Swallow Trigger
Description
the interval in seconds between the first frame showing barium passing the posterior tongue to the first frame showing laryngeal elevation.
Time Frame
<2seconds post swallow trigger
Title
Laryngeal Penetration, Mild
Description
the occurrence of barium underneath the epiglottis, remaining in the upper 1/3 quadrant of the laryngeal vestibule
Time Frame
<2 seconds post swallow trigger
Title
Laryngeal Penetration, Deep
Description
the occurrence of barium underneath the epiglottis, in the laryngeal vestibule to the level of the vocal folds
Time Frame
<2 seconds post swallow trigger
Title
Tracheal Aspiration
Description
the occurrence of barium below the level of the true vocal cords
Time Frame
<5 seconds post swallow trigger
Title
Nasopharyngeal Reflux
Description
the occurrence of barium detected in the nasopharynx, posterior or superior to the velum
Time Frame
<2 seconds post swallow trigger
Secondary Outcome Measure Information:
Title
Pharyngeal residue
Description
the presence of residual barium coating the pharyngeal walls, pooling in the vallecula or pyriform sinuses post swallow (absent/mild/severe).
Time Frame
<5 seconds post swallow trigger
Title
Silent Aspiration
Description
occurrence of a cough in the presence of aspiration (present/absent)
Time Frame
<5 seconds post swallow trigger
Title
Laryngeal Clearance
Description
ability to clear larynx during penetration events (sufficient/insufficient)
Time Frame
<5 seconds post swallow trigger
Title
Tracheal Clearance
Description
ability to clear trachea during aspiration events (sufficient/insufficient)
Time Frame
<5 seconds post swallow trigger

10. Eligibility

Sex
All
Maximum Age & Unit of Time
43 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Infants born prematurely with a corrected gestational age of 43 weeks or greater.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louisa Ferrara, MS, CCC-SLP
Organizational Affiliation
Winthrop University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States

12. IPD Sharing Statement

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The Effects of Cold Liquids on the Swallowing Mechanism in Preterm Infants

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