Cold Liquids Fed to Preterm Infants: Efficacy and Safety After 10 Minutes of Exposure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 4,043
- Locations
- 2
- Primary Endpoint
- Pharyngeal Phase Dysphagia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 36 Weeks to 43 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Pharyngeal Phase Dysphagia
Time Frame: <5 seconds post swallow trigger
presence of atypical or disordered movements during the pharyngeal phase of swallowing
Secondary Outcomes
- 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)