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N/A N=7 Prevention

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

Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Pharyngeal Phase Dysphagia — 7; 7 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
NCPAP (Device); Varibar® Thin Liquid Barium Sulfate for Suspension (Dietary_supplement)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
NYU Langone Health
Primary completion
Aug 2015

Outcome Measures

OutcomeResultp-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

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.

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
View full record on ClinicalTrials.gov →

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.

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