Dysphagia of Newborn
Conditions
Brief summary
It is estimated that 30-70% of very low birth weight (VLBW) preterm infants will be diagnosed with swallowing dysfunction (dysphagia), which often leads to airway compromise in the form of laryngeal penetration and/or tracheal aspiration during oral feeding attempts. Chronic airway compromise results in a persistent inflammatory state, with disease progression that can be devastating for already fragile and developmentally immature lungs in preterm infants. At this time, there are limited therapeutic options for dysphagia in VLBW infants during oral feeding. In a recent publication, our research group was the first to demonstrate that short-duration of oral feeding with cold liquid reduces dysphagia occurrence from 71% to 26%. However, these data must be further validated for the effectiveness and safety of a full duration feeding before being recommended for routine clinical practice. The objective is to identify preliminary evidence for the efficacy and safety of feeding full oral cold milk for dysphagia management in preterm infants. We hypothesize that oral feeding of cold milk in VLBW preterm infants with dysphagia will improve suck/swallow/breathe coordination and decrease penetration/ aspiration to the airway. We further hypothesize that cold milk intervention will have no adverse effects on intestinal blood flow, as assessed by Doppler Ultrasound. This is significant because there is a critical need to identify effective and safe evidence-based treatment options for dysphagia management in preterm infants. This prospective study will seek to enroll Subjects who meet the following inclusion criteria: 1) VLBW (birth weight less than 1,500g and less than 32 weeks gestation), 2) admitted to NYU-Winthrop Neonatal Intensive Care Unit (NICU), 3) Post-menstrual age (PMA) \> 35 weeks at the time of the study, 4) receiving no or minimum respiratory support (\<1 lit/min low-flow nasal cannula), 5) tolerating at least 50% of their enteral feeding orally, 6) having symptoms of swallowing dysfunction during oral feeding (clinical dysphagia) and 7) referred by the medical team for video fluoroscopic swallow study (VFSS) and/or fiberoptic endoscopic evaluation of swallowing (FEES). To assess the efficacy of cold milk in treating dysphagia, study subjects will first have an oral motor feeding assessment using an FDA approved device called the nFant® Feeding Solution as well as VFSS and/or FEES. To assess the safety of using cold milk, subjects will receive a doppler ultrasound before and after the ingestion of cold liquid feeding to assess the mesenteric blood flow.
Interventions
Standard room temperature (RTS) milk/formula will be given for an entire feeding (15-20 minutes).
If the infant shows signs of dysphagia cold temperature (CS, at 4-9°C) milk/formula will be given for an entire feeding (15-20 minutes).
Sponsors
Study design
Intervention model description
This will be a prospective study, with each infant serving as their own control. The order of each condition will be randomized to control for fatigue
Eligibility
Inclusion criteria
1. Viable preterm infants less than 34 weeks gestation 2. admitted to NYU- Langone Long Island Hospital NICU 3. PMA \> 35 weeks at the time of the study 4. receiving no or minimum respiratory support (\<2 lit/min low-flow nasal cannula) 5. tolerating at least 50% of their enteral feeding orally and 6. having symptoms of swallowing dysfunction during oral feeding (clinical dysphagia). 7. referred by the medical team for VFSS and/or FEES assessments.
Exclusion criteria
Infants with other comorbidities, such as IUGR, upper airway anomalies, brain injury, neuromuscular disease, or life-threatening congenital disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Infants With Improvement of Dysphagia | 15-20 minutes post cold milk feeding | Dysphagia will be assessed by Video Fluoroscopic Swallow Study (VFSS) and/or Fiberoptic Endoscopic Evaluation of Swallowing (FEES). If the infants showed signs of dysphagia they would receive cold cold milk and improvements in dysphagia would be assessed again by VFSS and FEES. |
| Axillary Temperature of Infants Post Room Temperature Feeding | Post feeding (up to 5 minutes) | Outcome measure will be assessed by measuring Axillary temperatures. The axillary temperature will be taken directly after feeding. |
| Percentage of Infants With Change in Vital Signs Due to Cold Milk | 24 hours | Outcome measure will be assessed by monitoring changes in respiratory rate, heart rate, and oxygen saturation. |
| Change in Peak Systolic Velocity (PSV) (60 Minutes Post Feeding) | Baseline (prior to feeding), 60 minutes after feeding | Outcome measure will be assessed by abdominal ultrasound. Peak systolic velocity (PSV) was measured for each patient before feeding (room temp or cold milk) as well as 60 minutes after feeding (room temp and cold milk). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Very Low Birth Weight Preterm Infants Very Low Birth Weight Preterm Infants (birth weight less than 1,500g and less than 32 weeks gestation) admitted to NYU Winthrop NICU. Infants will first receive room temperature milk and then be assessed for signs of dysphagia. Only infants that show signs of dysphagia will receive cold milk. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Very Low Birth Weight Preterm Infants |
|---|---|
| Age, Continuous | 32 weeks gestation |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Axillary Temperature of Infants Post Room Temperature Feeding
Outcome measure will be assessed by measuring Axillary temperatures. The axillary temperature will be taken directly after feeding.
Time frame: Post feeding (up to 5 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Very Low Birth Weight Preterm Infants | Axillary Temperature of Infants Post Room Temperature Feeding | 98.2 Degrees fahrenheit | Standard Deviation 0.3 |
Change in Peak Systolic Velocity (PSV) (60 Minutes Post Feeding)
Outcome measure will be assessed by abdominal ultrasound. Peak systolic velocity (PSV) was measured for each patient before feeding (room temp or cold milk) as well as 60 minutes after feeding (room temp and cold milk).
Time frame: Baseline (prior to feeding), 60 minutes after feeding
Population: The outcome measure was not collected after the first five infants, as the analysis showed no significant change. As a result, there was no justification for continuing data collection or subjecting the remaining infants to the procedure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Very Low Birth Weight Preterm Infants | Change in Peak Systolic Velocity (PSV) (60 Minutes Post Feeding) | 1.1 cm/s |
Percentage of Infants With Change in Vital Signs Due to Cold Milk
Outcome measure will be assessed by monitoring changes in respiratory rate, heart rate, and oxygen saturation.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Very Low Birth Weight Preterm Infants | Percentage of Infants With Change in Vital Signs Due to Cold Milk | 0 Participants |
Percentage of Infants With Improvement of Dysphagia
Dysphagia will be assessed by Video Fluoroscopic Swallow Study (VFSS) and/or Fiberoptic Endoscopic Evaluation of Swallowing (FEES). If the infants showed signs of dysphagia they would receive cold cold milk and improvements in dysphagia would be assessed again by VFSS and FEES.
Time frame: 15-20 minutes post cold milk feeding
Population: Infants were assessed post room temp milk feeding for dysphagia. If they showed signs of dysphagia, they would receive cold milk. Therefore only infants showing dysphagia either by FEES or VFSS were included in the analysis, as not all infants received cold milk during this assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Very Low Birth Weight Preterm Infants | Percentage of Infants With Improvement of Dysphagia | 58 Percentage of patients |