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

Primary Purpose

Deglutition Disorders, Respiratory Aspiration

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

About this trial

This is an interventional treatment trial for Deglutition Disorders focused on measuring pharyngeal swallow, NICU, intervention, thickening

Eligibility Criteria

36 Weeks - 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 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Room Temperature Swallows

Cold Liquid Swallows- 5

Cold Liquid Swallows- 10

Arm Description

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.

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."

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."

Outcomes

Primary Outcome Measures

Pharyngeal Phase Dysphagia
presence of atypical or disordered movements during the pharyngeal phase of swallowing

Secondary Outcome Measures

Tracheal Aspiration
the occurrence of barium below the level of the true vocal cords
Laryngeal Penetration
the occurrence of barium underneath the epiglottis, in the laryngeal vestibule to the level of the vocal folds
Nasopharyngeal Reflux
the occurrence of barium detected in the nasopharynx, posterior or superior to the velum
Pharyngeal residue
the presence of residual barium coating the pharyngeal walls, pooling in the vallecula or pyriform sinuses post swallow (absent/mild/severe).

Full Information

First Posted
October 13, 2016
Last Updated
January 31, 2023
Sponsor
NYU Langone Health
Collaborators
Adelphi University
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1. Study Identification

Unique Protocol Identification Number
NCT02935946
Brief Title
Cold Liquids Fed to Preterm Infants: Efficacy and Safety After 10 Minutes of Exposure
Official Title
Cold Liquids Fed to Preterm Infants: Efficacy and Safety After 10 Minutes of Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 2016 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Swallowing dysfunction, medically defined as dysphagia, commonly occurs in infants born prematurely due to inadequate timing and coordination of the sensorimotor sequences required for safe swallowing. Approximately 70% of prematurely born infants will be diagnosed with oral, pharyngeal and/or esophageal phase dysphagia with an inverse relationship between severity and gestational age at birth.(1) Swallowing is extremely important for the infant and child to meet the nutritional requirements for growth and development. When swallowing is dysfunctional, the consequences can be devastating for the infant, possibly resulting morbidity, with complications including pneumonia, respiratory disease, growth compromise or failure to thrive.(1-6) The implications of swallowing difficulty are, therefore, of considerable medical importance to the medical team working with these infants. A videofluoroscopic swallow study (VFSS) is a widely used assessment for the diagnosis of neonatal dysphagia. VFSS is a definitive investigation to objectively assess the adequacy of airway protection during swallowing and allows simultaneous viewing of the bolus as it passes through the oral, pharyngeal and esophageal stages of swallowing.(7) For infants feeding from a bottle, the clinician relies on the VFSS to both identify and correct the swallowing dysfunction. Several therapeutic techniques or modifications are used during a VFSS to improve swallowing safety in infants, such as various nipple flow rates,(8,9) feeding positions,(10) or pacing the infant's sucking bursts.(11) The most frequently used modification is to thicken the infant's formula or breastmilk to a thicker consistency,(12-14) however, thickening causes some difficulty making it an undesirable option for young infants treated in the neonatal intensive care unit (NICU).(15) These difficulties have resulted in clinicians using alternate therapeutic techniques to treat dysphagia neonates. One alternate technique is to feed the infant cold liquids to stimulate a safer swallow.(16-20) Original findings obtained by these investigators was the first to indicate that cold liquid swallows reduce airway compromise in dysphagic preterm infants when compared to room temperature liquid. Specifically, the occurrence of deep penetration (p=0.029), aspiration (0.017), mild penetration (p=0.044) and nasopharyngeal reflux (p=0.006) decreased significantly in the cold swallow (CS) condition when compared to the room temperature swallow (RTS) condition during VFSS. Similar findings are documented in adults with dysphagia.(21-35) These positive effects are theorized to occur due to the cold liquid providing the sensory receptors within the pharynx increased sensory information which triggers more efficient swallowing movements.(12,13,21-23) The original study assessed 5 cold liquid swallows, which provided important information regarding the immediate effects of cold liquids on the pharyngeal swallowing mechanism in preterm infants with dysphagia. Further information regarding the duration of these positive effects is necessary to prove its reliability as a modification to be used at bedside. This study is designed to assess the swallowing mechanism of dysphagic preterm infants after feeding cold liquids for 10 minutes to objectively identify any changes over time. In addition to the paucity of evidence regarding improved swallowing function over time, the safety of feeding cold liquids remains questionable in the preterm infant population. The greatest concern for these infants is the development of cold stress or altered digestive functioning due to the cold temperature of the liquid. The effects of cold stress in infants are observed in all body systems, including cool skin, tachypnea, respiratory distress, desaturation, increasing episodes of apnea and bradycardia, increased gastric residuals, and emesis.(36) Several older studies have assessed the effects of cold feeds in healthy term and healthy pre term infants, however, study populations may not be representative of todays preterm infant population due to significant medical advances and increased survival rates of extremely preterm infants. Holt and colleagues(37) found no difference in sleep pattern, vocalizations, motility, intake, feeding behavior, weight gain, temperature or regurgitation in preterm infants with a weight of >1,500gm, when fed cold formula. Gonzalez and colleagues(38) found no significant differences in axillary temperature or gastric residuals in preterm infants fed cold (0-4°C) verses room temperature (25°C) milk. Participants included 14 preterm infants with a gestational age at birth (GAB) of 28-30w, and a mean corrected gestational age of 32 weeks. Anderson and Berseth(39) found no differences in infants' antral or duodenal motor activity as assessed via manometry, as well as gastric emptying among cold (6°C), room temperature (24°C), or body temperature (37°C) feeding groups. This study included preterm infants with GAB 25-36weeks, mean birth weights 915-2,455g. Corrected gestational age of 32-36 weeks at the time of the study. Feedings were given in random order for 3 liquid temperatures. Across all temperatures they found that all infants emptied approximately one third of the bolus feeding by 20 minutes. And across all temperatures approximately 10-20% of the bolus feeding remained in their stomach 2 hours post-prandially. The authors propose that thermo-receptors within the gastrointestinal tract do not appear to be functional in this age group. Blumenthal and colleagues(40) found no statistical differences between stomach emptying rate in cold (0-4°C), room temperature (25°C) or body temperature (37°C) formula in 20 healthy preterm infants with a mean birth weight of 2.75 ± 0-18 (range 1.49-3.38) kg, and gestation 37-7 ± 0.6 (range 34-41) weeks. They also reported that in all infants the cold feeds were well tolerated and produced no obvious clinical effects. To assess the potential risks of cold stress, each participant's body temperature will be obtained pre and post cold liquid exposure. To assess digestive functioning, the temperature of each participant's gastric contents will be obtained pre and post cold liquid exposure by extraction of the gastric content via a naso-gastric tube (NGT). If the child does not have a naso-gastric tube in place at the time of the study, the subjects will be enrolled but no documentation of the stomach content temperature will be obtained.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition Disorders, Respiratory Aspiration
Keywords
pharyngeal swallow, NICU, intervention, thickening

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Room Temperature Swallows
Arm Type
No Intervention
Arm Description
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.
Arm Title
Cold Liquid Swallows- 5
Arm Type
Experimental
Arm Description
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."
Arm Title
Cold Liquid Swallows- 10
Arm Type
Experimental
Arm Description
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."
Intervention Type
Other
Intervention Name(s)
Cold Liquid Barium
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pharyngeal Phase Dysphagia
Description
presence of atypical or disordered movements during the pharyngeal phase of swallowing
Time Frame
<5 seconds post swallow trigger
Secondary Outcome Measure Information:
Title
Tracheal Aspiration
Description
the occurrence of barium below the level of the true vocal cords
Time Frame
<5 seconds post swallow trigger
Title
Laryngeal Penetration
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
Nasopharyngeal Reflux
Description
the occurrence of barium detected in the nasopharynx, posterior or superior to the velum
Time Frame
<2 seconds post swallow trigger
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Weeks
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
Nazeeh Hanna, MD
Organizational Affiliation
NYU Winthrop 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

Plan to Share IPD
Yes
IPD Sharing Plan Description
in publication
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Cold Liquids Fed to Preterm Infants: Efficacy and Safety After 10 Minutes of Exposure

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