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Effect of Nasal Continuous Positive Airway Pressure on The Pharyngeal Swallow in Neonates

NCT02661256 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2019-09-25

Study results available
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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.

Conditions

  • Deglutition Disorders
  • Respiratory Distress Syndrome In Premature Infants
  • Respiratory Aspiration
  • Newborn, Premature

Interventions

DEVICE

NCPAP

Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.

DIETARY_SUPPLEMENT

Varibar® Thin Liquid Barium Sulfate for Suspension

Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.

Sponsors & Collaborators

Principal Investigators

  • Nazeeh Hanna, MD · NYU Langone Winthrop University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
34 Weeks
Max Age
45 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-08-31
Completion
2015-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02661256 on ClinicalTrials.gov