Deglutition Disorders Clinical Trial
Official title:
Effect of Nasal Continuous Positive Airway Pressure on The Pharyngeal Swallow in Neonates
NCT number | NCT02661256 |
Other study ID # | WUH 14018 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2014 |
Est. completion date | September 2015 |
Verified date | September 2019 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Oral feeding of neonates while on nasal continuous positive airway pressure (NCPAP) is a common practice in many neonatal intensive care units (NICU) all over the country. However the safety of such practice has never been established. The Investigators hypothesize that mechanoreceptors, which should perceive sensory input from the liquid bolus, may be altered by the reception of pressurized airflow provided by the NCPAP, hence increase risk of aspiration. In this study, changes in the pharyngeal phase of swallowing were identified using video fluoroscopic swallow studies (VFSS) for infants while on NCPAP as compared to off NCPAP.
Status | Completed |
Enrollment | 7 |
Est. completion date | September 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 34 Weeks to 45 Weeks |
Eligibility |
Inclusion Criteria: - Infants in neonatal ICU requiring NCPAP and tolerating at least 50% of their total required intake by mouth from a bottle, as determined by their medical team. Exclusion Criteria: - Infants with other comorbidity such as upper airway anomalies, brain injury neuromuscular disease, life threatening congenital disease. Any symptomatic intercurrent acute disease e.g. infectious disease |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharyngeal Phase Dysphagia | presence of atypical or disordered movements during the pharyngeal phase of swallowing | <5 seconds post swallow trigger | |
Secondary | Tracheal Aspiration | the occurrence of barium below the level of the true vocal cords | <5 seconds post swallow trigger | |
Secondary | Percentage of Laryngeal Length | Will be measuredmeasured by deep penetration, the occurrence of barium underneath the epiglottis, in the laryngeal vestibule to the level of the vocal folds | <2 seconds post swallow trigger | |
Secondary | Silent Aspiration | The 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). | <5 seconds post swallow trigger | |
Secondary | Nasopharyngeal Reflux | the occurrence of barium detected in the nasopharynx, posterior or superior to the velum | <2 seconds post swallow trigger | |
Secondary | Pharyngeal Residue | the 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). | <5 seconds post swallow trigger |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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