AzTrials
AzTrials

Deglutition DisordersNCT02935946

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

A study testing Cold Liquid Barium in people with Deglutition Disorders and Respiratory Aspiration, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 36 to 43 weeks
Conditions the study is for
Deglutition Disorders, Respiratory Aspiration
What is being tested?
Cold Liquid Barium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,043 participants
Where
1 siteUnited States
Study dates
Oct 2016to 17 Mar 2024
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 36 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

Other trials in United States

About this study

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.

Read the 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.

Being tested
Cold Liquid Barium
Keywords
pharyngeal swallow, NICU, intervention, thickening
Medical subject headings
Deglutition Disorders, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cold Liquid BariumOther

    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.

Study groups in NCT02935946
Study groupRoleWhat they receive
Room Temperature SwallowsNo interventionOnce 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- 5ExperimentalImmediately 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."
Receives: Other: Cold Liquid Barium
Cold Liquid Swallows- 10ExperimentalAfter 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."
Receives: Other: Cold Liquid Barium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharyngeal Phase Dysphagia

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

    Measured: <5 seconds post swallow trigger

Secondary outcomes (4)
  1. Tracheal Aspiration

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

    Measured: <5 seconds post swallow trigger

  2. Laryngeal Penetration

    the occurrence of barium underneath the epiglottis, in the laryngeal vestibule to the level of the vocal folds

    Measured: <2 seconds post swallow trigger

  3. Nasopharyngeal Reflux

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

    Measured: <2 seconds post swallow trigger

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completion17 Mar 2024
  4. Study completion17 Mar 2024

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
4,043 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02935946
Sponsor's protocol ID
19-00901
Status last verified
Jun 2024
First submitted
13 Oct 2016
Last updated
24 Jun 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: in publication

Publications

  • Newman LA, Keckley C, Petersen MC, Hamner A. Swallowing function and medical diagnoses in infants suspected of Dysphagia. Pediatrics. 2001 Dec;108(6):E106. doi: 10.1542/peds.108.6.e106.

    PubMed 11731633
  • Boesch RP, Wood, RE. (2012). Aspiration. In: Kendig and Chernick's Disorders of the Respiratory Track in Children 8th Edition. Elsevier: Philladelphi: PA, 2012, pp 947-948.

  • Taniguchi MH, Moyer RS. Assessment of risk factors for pneumonia in dysphagic children: significance of videofluoroscopic swallowing evaluation. Dev Med Child Neurol. 1994 Jun;36(6):495-502. doi: 10.1111/j.1469-8749.1994.tb11879.x.

    PubMed 8005360
  • Orenstein SR. Oral, pharyngeal, and esophageal motor disorders in infants and children. GI Motility Online 2006. doi:10.1038/gimo38. Available at: http://www.nature.com/gimo/contents/pt1/full/gimo38.html

  • Smith CH, Logemann JA, Colangelo LA, Rademaker AW, Pauloski BR. Incidence and patient characteristics associated with silent aspiration in the acute care setting. Dysphagia. 1999 Winter;14(1):1-7. doi: 10.1007/PL00009579.

    PubMed 9828268
  • Tutor JD, Gosa MM. Dysphagia and aspiration in children. Pediatr Pulmonol. 2012 Apr;47(4):321-37. doi: 10.1002/ppul.21576. Epub 2011 Oct 18.

    PubMed 22009835
  • Hiorns MP, Ryan MM. Current practice in paediatric videofluoroscopy. Pediatr Radiol. 2006 Sep;36(9):911-9. doi: 10.1007/s00247-006-0124-3. Epub 2006 Mar 22.

    PubMed 16552584
  • Mathew OP. Breathing patterns of preterm infants during bottle feeding: role of milk flow. J Pediatr. 1991 Dec;119(6):960-5. doi: 10.1016/s0022-3476(05)83056-2.

    PubMed 1960618
  • Chang YJ, Lin CP, Lin YJ, Lin CH. Effects of single-hole and cross-cut nipple units on feeding efficiency and physiological parameters in premature infants. J Nurs Res. 2007 Sep;15(3):215-23. doi: 10.1097/01.jnr.0000387617.72435.c6.

    PubMed 17806038
  • Clark L, Kennedy G, Pring T, Hird M. Improving bottle feeding in preterm infants: Investigating the elevated side-lying position. Infant 2007; 3:154-158.

  • Law-Morstatt L, Judd DM, Snyder P, Baier RJ, Dhanireddy R. Pacing as a treatment technique for transitional sucking patterns. J Perinatol. 2003 Sep;23(6):483-8. doi: 10.1038/sj.jp.7210976.

    PubMed 13679936
  • Logemann JA. The dysphagia diagnostic procedure as a treatment efficacy trial. Clin Commun Disord. 1993 Fall;3(4):1-10.

    PubMed 8111359
  • Ruark JL, McCullough GH, Peters RL, Moore CA. Bolus consistency and swallowing in children and adults. Dysphagia. 2002 Winter;17(1):24-33. doi: 10.1007/s00455-001-0098-0.

    PubMed 11820384
  • Khoshoo V, Ross G, Kelly B, Edell D, Brown S. Benefits of thickened feeds in previously healthy infants with respiratory syncytial viral bronchiolitis. Pediatr Pulmonol. 2001 Apr;31(4):301-2. doi: 10.1002/ppul.1043.

    PubMed 11288213
  • Cichero JA, Nicholson TM, September C. Thickened milk for the management of feeding and swallowing issues in infants: a call for interdisciplinary professional guidelines. J Hum Lact. 2013 May;29(2):132-5. doi: 10.1177/0890334413480561. Epub 2013 Mar 18. No abstract available.

    PubMed 23507962

Questions about this trial

What is this clinical trial studying?

A study testing Cold Liquid Barium in people with Deglutition Disorders and Respiratory Aspiration, 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 24 Jun 2024. 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 Phase Dysphagia (time frame: <5 seconds post swallow trigger). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02935946, which also lists 44 linked publications.

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 24 Jun 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in