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

NCT02661256 | Completed Results DMC

• 1 other identifier: WUH 14018
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

pharyngeal swallow; airway compromise; NICU

Outcome Measures

Primary Outcomes (1)

• Pharyngeal Phase Dysphagia

  presence of atypical or disordered movements during the pharyngeal phase of swallowing

  <5 seconds post swallow trigger

Secondary Outcomes (5)

• Tracheal Aspiration

  <5 seconds post swallow trigger

• Percentage of Laryngeal Length

  <2 seconds post swallow trigger

• Silent Aspiration

  <5 seconds post swallow trigger

• Nasopharyngeal Reflux

  <2 seconds post swallow trigger

• Pharyngeal Residue

  <5 seconds post swallow trigger

Study Arms (2)

on NCPAP

ACTIVE COMPARATOR

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.

Device: NCPAP; Dietary Supplement: Varibar® Thin Liquid Barium Sulfate for Suspension

Off NCPAP

ACTIVE COMPARATOR

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.

Device: NCPAP; Dietary Supplement: Varibar® Thin Liquid Barium Sulfate for Suspension

Interventions

NCPAP DEVICE

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

Also known as: Continuous Positive Airway Pressure

Off NCPAP; on NCPAP

Varibar® Thin Liquid Barium Sulfate for Suspension DIETARY_SUPPLEMENT

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

Off NCPAP; on NCPAP

Eligibility Criteria

• Age: 34 Weeks - 45 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Deglutition Disorders; Respiratory Distress Syndrome In Premature Infants; Respiratory Aspiration; Premature Birth

Interventions

Continuous Positive Airway Pressure; Suspensions

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

Small number of subjects: Enrollment was stopped after 7 participants due to the documented risks associated with oral feeding on NCPAP. It was unethical to expose infants to harm after clear safety risk was identified.

Results Point of Contact

• Title: Nazeeh Hanna, MD
• Organization: NYU-Winthrop Hospital

nazeehhanna@gmail.com

6314211424

Study Officials

• Nazeeh Hanna, MD

  NYU Langone Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 22, 2016
• Study Start: June 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 25, 2019
• Results First Posted: July 23, 2019

Record last verified: 2019-09