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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01863264
Other study ID # 460111-3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2013
Est. completion date December 2015

Study information

Verified date February 2019
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group N/A to 43 Weeks
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cold Thin Liquid Barium
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.

Locations

Country Name City State
United States Winthrop University Hospital Mineola New York

Sponsors (1)

Lead Sponsor Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharyngeal Swallow Trigger the interval in seconds between the first frame showing barium passing the posterior tongue to the first frame showing laryngeal elevation. <2seconds post swallow trigger
Primary Laryngeal Penetration, Mild the occurrence of barium underneath the epiglottis, remaining in the upper 1/3 quadrant of the laryngeal vestibule <2 seconds post swallow trigger
Primary Laryngeal Penetration, Deep the occurrence of barium underneath the epiglottis, in the laryngeal vestibule to the level of the vocal folds <2 seconds post swallow trigger
Primary Tracheal Aspiration the occurrence of barium below the level of the true vocal cords <5 seconds post swallow trigger
Primary Nasopharyngeal Reflux the occurrence of barium detected in the nasopharynx, posterior or superior to the velum <2 seconds post swallow trigger
Secondary Pharyngeal residue the presence of residual barium coating the pharyngeal walls, pooling in the vallecula or pyriform sinuses post swallow (absent/mild/severe). <5 seconds post swallow trigger
Secondary Silent Aspiration occurrence of a cough in the presence of aspiration (present/absent) <5 seconds post swallow trigger
Secondary Laryngeal Clearance ability to clear larynx during penetration events (sufficient/insufficient) <5 seconds post swallow trigger
Secondary Tracheal Clearance ability to clear trachea during aspiration events (sufficient/insufficient) <5 seconds post swallow trigger
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