Trial Outcomes & Findings for Effect of Nasal Continuous Positive Airway Pressure on The Pharyngeal Swallow in Neonates (NCT NCT02661256)
NCT ID: NCT02661256
Last Updated: 2019-09-25
Results Overview
presence of atypical or disordered movements during the pharyngeal phase of swallowing
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
<5 seconds post swallow trigger
Results posted on
2019-09-25
Participant Flow
Recruitment Period: September 2014- August 2015. All participants were recruited from the Neonatal Intensive Care Unit (NICU) at Winthrop University Hospital, Mineola, NY.
Chart review- 26 preterm infants on nCPAP. Weaned off nCPAP before approaching-10. Excluded- 4 (h/o upper airway anomalies, brain injury, etc.). Eligible-12. Declined consent -5. Consented-7. Screening and VFSS completed-7. Analyzed-7. None of the enrolled participants were excluded from the trial before assignment to groups.
Participant milestones
| Measure |
VFSS on nCPAP Then Off nCPAP
Once consented, each participant underwent a video fluoroscopic swallow study (VFSS) while NCPAP was administered via a RAM cannula® (intervention). With the NCPAP turned on 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 (standard flow), a total of 20 swallows were recorded. These swallows were termed "on NCPAP" swallows. The swallows were assessed in real time for any swallowing dysfunction.
Immediately following the "on NCPAP" condition, an additional 20 swallows were recorded under VFSS with the NCPAP turned off (intervention). These swallows were termed "off NCPAP" swallows.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Nasal Continuous Positive Airway Pressure on The Pharyngeal Swallow in Neonates
Baseline characteristics by cohort
| Measure |
VFSS on nCPAP Then Off nCPAP
n=7 Participants
Once consented, each participant underwent a video fluoroscopic swallow study (VFSS) while NCPAP was administered via a RAM cannula® (intervention). With the NCPAP turned on 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 (standard flow), a total of 20 swallows were recorded. These swallows were termed "on NCPAP" swallows. The swallows were assessed in real time for any swallowing dysfunction.
Immediately following the "on NCPAP" condition, an additional 20 swallows were recorded under VFSS with the NCPAP turned off (intervention). These swallows were termed "off NCPAP" swallows.
|
|---|---|
|
Age, Customized
|
37 weeks
n=39 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: <5 seconds post swallow triggerpresence of atypical or disordered movements during the pharyngeal phase of swallowing
Outcome measures
| Measure |
on NCPAP
n=7 Participants
Once consented, each participant underwent a video fluoroscopic swallow study (VFSS) while NCPAP was administered via a RAM cannula® (intervention). With the NCPAP turned on 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 (standard flow), a total of 20 swallows were recorded. These swallows were termed "on NCPAP" swallows. The swallows were assessed in real time for any swallowing dysfunction.
NCPAP: Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.
Varibar® Thin Liquid Barium Sulfate for Suspension: Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.
|
Off NCPAP
n=7 Participants
Immediately following the "on NCPAP" condition, an additional 20 swallows were recorded under VFSS with the NCPAP turned off (intervention). These swallows were termed "off NCPAP" swallows.
NCPAP: Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.
Varibar® Thin Liquid Barium Sulfate for Suspension: Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.
|
|---|---|---|
|
Pharyngeal Phase Dysphagia
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: <5 seconds post swallow triggerthe occurrence of barium below the level of the true vocal cords
Outcome measures
| Measure |
on NCPAP
n=7 Participants
Once consented, each participant underwent a video fluoroscopic swallow study (VFSS) while NCPAP was administered via a RAM cannula® (intervention). With the NCPAP turned on 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 (standard flow), a total of 20 swallows were recorded. These swallows were termed "on NCPAP" swallows. The swallows were assessed in real time for any swallowing dysfunction.
NCPAP: Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.
Varibar® Thin Liquid Barium Sulfate for Suspension: Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.
|
Off NCPAP
n=7 Participants
Immediately following the "on NCPAP" condition, an additional 20 swallows were recorded under VFSS with the NCPAP turned off (intervention). These swallows were termed "off NCPAP" swallows.
NCPAP: Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.
Varibar® Thin Liquid Barium Sulfate for Suspension: Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.
|
|---|---|---|
|
Tracheal Aspiration
|
33.5 percentage of aspiration
Standard Deviation 9.4
|
14.6 percentage of aspiration
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: <2 seconds post swallow triggerWill be measuredmeasured by deep penetration, the occurrence of barium underneath the epiglottis, in the laryngeal vestibule to the level of the vocal folds
Outcome measures
| Measure |
on NCPAP
n=7 Participants
Once consented, each participant underwent a video fluoroscopic swallow study (VFSS) while NCPAP was administered via a RAM cannula® (intervention). With the NCPAP turned on 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 (standard flow), a total of 20 swallows were recorded. These swallows were termed "on NCPAP" swallows. The swallows were assessed in real time for any swallowing dysfunction.
NCPAP: Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.
Varibar® Thin Liquid Barium Sulfate for Suspension: Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.
|
Off NCPAP
n=7 Participants
Immediately following the "on NCPAP" condition, an additional 20 swallows were recorded under VFSS with the NCPAP turned off (intervention). These swallows were termed "off NCPAP" swallows.
NCPAP: Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.
Varibar® Thin Liquid Barium Sulfate for Suspension: Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.
|
|---|---|---|
|
Percentage of Laryngeal Length
|
43.7 percentage of deep penetration
Standard Deviation 15.4
|
25.3 percentage of deep penetration
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: <5 seconds post swallow triggerThe occurrence of barium below the level of the vocal folds (aspiration) with no occurrence of cough (silent). This is a measure of absence of a cough during aspiration (silent aspiration).
Outcome measures
| Measure |
on NCPAP
n=7 Participants
Once consented, each participant underwent a video fluoroscopic swallow study (VFSS) while NCPAP was administered via a RAM cannula® (intervention). With the NCPAP turned on 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 (standard flow), a total of 20 swallows were recorded. These swallows were termed "on NCPAP" swallows. The swallows were assessed in real time for any swallowing dysfunction.
NCPAP: Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.
Varibar® Thin Liquid Barium Sulfate for Suspension: Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.
|
Off NCPAP
n=7 Participants
Immediately following the "on NCPAP" condition, an additional 20 swallows were recorded under VFSS with the NCPAP turned off (intervention). These swallows were termed "off NCPAP" swallows.
NCPAP: Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.
Varibar® Thin Liquid Barium Sulfate for Suspension: Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.
|
|---|---|---|
|
Silent Aspiration
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: <2 seconds post swallow triggerthe occurrence of barium detected in the nasopharynx, posterior or superior to the velum
Outcome measures
| Measure |
on NCPAP
n=7 Participants
Once consented, each participant underwent a video fluoroscopic swallow study (VFSS) while NCPAP was administered via a RAM cannula® (intervention). With the NCPAP turned on 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 (standard flow), a total of 20 swallows were recorded. These swallows were termed "on NCPAP" swallows. The swallows were assessed in real time for any swallowing dysfunction.
NCPAP: Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.
Varibar® Thin Liquid Barium Sulfate for Suspension: Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.
|
Off NCPAP
n=7 Participants
Immediately following the "on NCPAP" condition, an additional 20 swallows were recorded under VFSS with the NCPAP turned off (intervention). These swallows were termed "off NCPAP" swallows.
NCPAP: Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.
Varibar® Thin Liquid Barium Sulfate for Suspension: Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.
|
|---|---|---|
|
Nasopharyngeal Reflux
|
42.8 percentage of nasopharyngeal reflux
Standard Deviation 48.5
|
44.2 percentage of nasopharyngeal reflux
Standard Deviation 45.4
|
SECONDARY outcome
Timeframe: <5 seconds post swallow triggerthe presence of residual barium coating the pharyngeal walls, pooling in the vallecula or pyriform sinuses post swallow (absent/mild/severe). This measure is subjective (mild = light coating and sever = significant coating of residual barium).
Outcome measures
| Measure |
on NCPAP
n=7 Participants
Once consented, each participant underwent a video fluoroscopic swallow study (VFSS) while NCPAP was administered via a RAM cannula® (intervention). With the NCPAP turned on 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 (standard flow), a total of 20 swallows were recorded. These swallows were termed "on NCPAP" swallows. The swallows were assessed in real time for any swallowing dysfunction.
NCPAP: Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.
Varibar® Thin Liquid Barium Sulfate for Suspension: Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.
|
Off NCPAP
n=7 Participants
Immediately following the "on NCPAP" condition, an additional 20 swallows were recorded under VFSS with the NCPAP turned off (intervention). These swallows were termed "off NCPAP" swallows.
NCPAP: Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.
Varibar® Thin Liquid Barium Sulfate for Suspension: Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.
|
|---|---|---|
|
Pharyngeal Residue
absent
|
1 participants
|
3 participants
|
|
Pharyngeal Residue
mild
|
4 participants
|
4 participants
|
|
Pharyngeal Residue
severe
|
2 participants
|
0 participants
|
Adverse Events
on NCPAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Off NCPAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place