Cold Liquids Fed to Preterm Infants: Efficacy and Safety After 10 Minutes of Exposure

NCT02935946 | Completed DMC

• 1 other identifier: 19-00901
• Study Type: interventional
• Target: 4,043
• Locations: 1 country
• Sites: 1

Brief Summary

A previous study revealed that dysphagia preterm infants show statistically significant improvements in their swallowing mechanism when fed cold liquid barium when compared to room temperature liquid barium. The previous study was the first to identify these positive effects, although, only assessed 5 cold liquid swallows, immediately after the room temperature condition. This limited data set restricts the efficacy and safety of using cold liquids in clinical practice, emphasizing the need for further information. The present study aims to objectively assess the influence of cold liquid on the pharyngeal swallow mechanism in preterm infants with dysphagia after 10 minutes of a cold liquid feeding. The investigators will utilize videofluoroscopic swallow studies (VFSS) to analyze the frequency and severity of pharyngeal swallowing deficits during room temperature swallows and compare it to cold liquid swallows at various time points within a 10 minute feeding. Safety measures will also be obtained, such as participant axillary body temperature and gastric content temperature, to identify indicators for the development of cold stress.

Conditions

Deglutition Disorders; Respiratory Aspiration

Keywords

pharyngeal swallow, NICU, intervention, thickening

Outcome Measures

Primary Outcomes (1)

• Pharyngeal Phase Dysphagia

  presence of atypical or disordered movements during the pharyngeal phase of swallowing

  <5 seconds post swallow trigger

Secondary Outcomes (4)

• Tracheal Aspiration

  <5 seconds post swallow trigger

• Laryngeal Penetration

  <2 seconds post swallow trigger

• Nasopharyngeal Reflux

  <2 seconds post swallow trigger

• Pharyngeal residue

  <5 seconds post swallow trigger

Study Arms (3)

Room Temperature Swallows

NO 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.

Cold Liquid Swallows- 5

EXPERIMENTAL

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."

Other: Cold Liquid Barium

Cold Liquid Swallows- 10

EXPERIMENTAL

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."

Other: Cold Liquid Barium

Interventions

Cold Liquid Barium OTHER

Cold Liquid is defined as being between 4-9 °C. One liter bottles of Poland Spring Natural Spring Water will be kept in the radiology suite to remain at room temperature. As described by Fink and colleagues,(42) the bottled water will be used to mix the barium powder to create a thin liquid consistency, with 50% dilution, which is found to be most similar to human milk and infant formula. After the barium is prepared, 2oz will be poured into a bottle and placed in a refrigerator set to 36°F; this will allow the barium to cool to approximately 4-9°C. Before oral administration, the barium mixture will be measured with a thermometer (TP3001 Digital Thermometer from Red Lantern®) to document the exact temperature.

Cold Liquid Swallows- 10; Cold Liquid Swallows- 5

Eligibility Criteria

• Age: 36 Weeks - 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
• Adelphi University: collaborator

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

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MeSH Terms

Conditions

Deglutition Disorders; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nazeeh Hanna, MD

  NYU Winthrop Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 18, 2016
• Study Start: October 1, 2016
• Primary Completion: March 17, 2024
• Study Completion: March 17, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)