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

NCT01863264 | Completed

• 1 other identifier: 460111-3
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Keywords

dysphagia; swallowing; infant; premature; neonate; thermal; cold; bolus; temperature; deglutition; NICU; bottle; nippling

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• Tracheal Aspiration

  the occurrence of barium below the level of the true vocal cords

  <5 seconds post swallow trigger

• Nasopharyngeal Reflux

  the occurrence of barium detected in the nasopharynx, posterior or superior to the velum

  <2 seconds post swallow trigger

Secondary Outcomes (4)

• Pharyngeal residue

  <5 seconds post swallow trigger

• Silent Aspiration

  <5 seconds post swallow trigger

• Laryngeal Clearance

  <5 seconds post swallow trigger

• Tracheal Clearance

  <5 seconds post swallow trigger

Study Arms (1)

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.

Other: Cold Thin Liquid Barium

Interventions

Cold Thin Liquid Barium OTHER

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.

Also known as: Varibar® Thin Liquid Barium Sulfate for Suspension

Cold Thin Liquid Barium

Eligibility Criteria

• Age: Up to 43 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Premature Birth; Common Cold

Interventions

Suspensions

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Louisa Ferrara, MS, CCC-SLP

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 27, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

US (1)