N/A
Completed N=7
Effect of Nasal Continuous Positive Airway Pressure on The Pharyngeal Swallow in Neonates
Deglutition Disorders · Respiratory Distress Syndrome In Premature Infants · Respiratory Aspiration · Newborn, Premature
Source: ClinicalTrials.gov NCT02661256 ↗
Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Pharyngeal Phase Dysphagia — 7; 7 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharyngeal Phase Dysphagia |
7; 7 | — |
| SECONDARY Tracheal Aspiration |
33.5; 14.6 | — |
| SECONDARY Percentage of Laryngeal Length |
43.7; 25.3 | — |
| SECONDARY Silent Aspiration |
7; 7 | — |
| SECONDARY Nasopharyngeal Reflux |
42.8; 44.2 | — |
| SECONDARY Pharyngeal Residue |
1; 3; 4; 4; 2; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02661256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.