DysphagiaNCT01863264
The Effects of Cold Liquids on the Swallowing Mechanism in Preterm Infants
A study testing Cold Thin Liquid Barium in people with Dysphagia, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 43 weeks
- Conditions the study is for
- Dysphagia
- What is being tested?
- Cold Thin Liquid Barium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 43 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Infants born prematurely with a corrected gestational age of 43 weeks or greater.
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: A Pilot Study on The Effects of Cold Liquids on the Pharyngeal Swallow in Preterm Infants With Dysphagia.
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.
Read the 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.
- Conditions
- Dysphagia
- Being tested
- Cold Thin Liquid Barium
- Keywords
- dysphagia, swallowing, infant, premature, neonate, thermal, cold, bolus, temperature, deglutition, NICU, bottle, nippling
- Medical subject headings
- Deglutition Disorders, Premature Birth, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Thin Liquid BariumOther
Also called Varibar® Thin Liquid Barium Sulfate for Suspension
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.
| Study group | Role | What they receive |
|---|---|---|
| Cold Thin Liquid Barium | Experimental | 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. Receives: Other: Cold Thin Liquid Barium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharyngeal Swallow Trigger
the interval in seconds between the first frame showing barium passing the posterior tongue to the first frame showing laryngeal elevation.
Measured: <2seconds post swallow trigger
Laryngeal Penetration, Mild
the occurrence of barium underneath the epiglottis, remaining in the upper 1/3 quadrant of the laryngeal vestibule
Measured: <2 seconds post swallow trigger
Laryngeal Penetration, Deep
the occurrence of barium underneath the epiglottis, in the laryngeal vestibule to the level of the vocal folds
Measured: <2 seconds post swallow trigger
Tracheal Aspiration
the occurrence of barium below the level of the true vocal cords
Measured: <5 seconds post swallow trigger
Nasopharyngeal Reflux
the occurrence of barium detected in the nasopharynx, posterior or superior to the velum
Measured: <2 seconds post swallow trigger
Secondary outcomes (4)
Pharyngeal residue
the presence of residual barium coating the pharyngeal walls, pooling in the vallecula or pyriform sinuses post swallow (absent/mild/severe).
Measured: <5 seconds post swallow trigger
Silent Aspiration
occurrence of a cough in the presence of aspiration (present/absent)
Measured: <5 seconds post swallow trigger
Laryngeal Clearance
ability to clear larynx during penetration events (sufficient/insufficient)
Measured: <5 seconds post swallow trigger
Tracheal Clearance
ability to clear trachea during aspiration events (sufficient/insufficient)
Measured: <5 seconds post swallow trigger
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louisa Ferrara, MS, CCC-SLP, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863264
- Sponsor's protocol ID
- 460111-3
- Status last verified
- Feb 2019
- First submitted
- 22 May 2013
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on The Effects of Cold Liquids on the Pharyngeal Swallow in Preterm Infants With Dysphagia.
- ClinicalTrials.gov ID
- NCT01863264
- Acronym / sponsor ID
- 460111-3
- Conditions
- Dysphagia
- Keywords
- dysphagia, swallowing, infant, premature, neonate, thermal, cold, bolus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cold Thin Liquid Barium | Experimental | Other: Cold Thin Liquid BariumPoland 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. |
Who may qualify
- Ages
- Up to 43 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Infants born prematurely with a corrected gestational age of 43 weeks or greater.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Thin Liquid BariumAlso: Varibar® Thin Liquid Barium Sulfate for SuspensionCold 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. | Other | Cold Thin Liquid Barium |
Primary outcome
Pharyngeal Swallow Trigger
Time frame: <2seconds post 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
Time frame: <2 seconds post swallow trigger
the occurrence of barium underneath the epiglottis, remaining in the upper 1/3 quadrant of the laryngeal vestibule
Laryngeal Penetration, Deep
Time frame: <2 seconds post swallow trigger
the occurrence of barium underneath the epiglottis, in the laryngeal vestibule to the level of the vocal folds
Tracheal Aspiration
Time frame: <5 seconds post swallow trigger
the occurrence of barium below the level of the true vocal cords
Nasopharyngeal Reflux
Time frame: <2 seconds post swallow trigger
the occurrence of barium detected in the nasopharynx, posterior or superior to the velum
4 secondary outcomes
Pharyngeal residue
Time frame: <5 seconds post swallow trigger
Silent Aspiration
Time frame: <5 seconds post swallow trigger
Laryngeal Clearance
Time frame: <5 seconds post swallow trigger
Tracheal Clearance
Time frame: <5 seconds post swallow trigger
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louisa Ferrara, MS, CCC-SLP principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Thin Liquid Barium in people with Dysphagia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharyngeal Swallow Trigger (time frame: <2seconds post swallow trigger). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.