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High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure

This study is currently recruiting participants.
Verified October 2012 by Christiana Care Health Services
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT01531465
First received: May 25, 2011
Last updated: October 26, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to compare two common methods of providing respiratory support: nasal continuous airway pressure and high flow nasal cannula to see what effect it has on babies breathing. The investigators also will compare the effects of slightly changing the level of support these two different types of therapy on how easily your baby is breathing. Changes in the level of support and between these two respiratory support modalities are frequently done and are part of the routine care in the neonatal intensive care unit.


Condition Intervention
Respiratory Insufficiency
 Other: Pulmonary Function Testing & esophageal pressure monitoring
Other: Pulmonary function testing and esophageal pressure

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pulmonary Function Testing in Infants With Respiratory Insufficiency While Receiving High Flow Nasal Cannula (HFNC) Versus Nasal Continuous Positive Airway Pressure (nCPAP)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • lung compliance [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Is there a difference in pulmonary function tests in infants with respiratory insufficiency being treated with high flow nasal cannula (HFNC) or nasal continuous positive airway pressure (NCPAP)?


Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HFNC to NCPAP
Infants who are currently on HFNC.
 Other: Pulmonary function testing and esophageal pressure
Infants who are currently on HFNC will have pulmonary function testing (PFTs) and esophageal pressure performed while on 2 different settings of HFNC. These infants will then be transitioned NCPAP and will undergo PFTs and esophageal pressure while on 2 different NCPAP settings. The infant will then be returned to HFNC at the same settings they were on prior to any study interventions.
Other Names:
  • Pulmonary Function Testing
  • Esophageal pressure
NCPAP to HFNC
Infants who are currently on NCPAP.
 Other: Pulmonary Function Testing & esophageal pressure monitoring
Infants who are currently on NCPAP will have pulmonary function testing (PFTs)and esophageal pressure performed while on 2 different settings of NCPAP. These infants will then be transitioned HFNC and will undergo PFTs and esophageal pressure while on different HFNC settings. The infant will then be returned to NCPAP at the same settings they were on prior to any study interventions.
Other Names:
  • Pulmonary Function Testing
  • Esophageal pressure

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants who are between 28 and 40 weeks of corrected gestational age at the time of study entry
  • Currently on high flow nasal cannula receiving 3 to 5 lpm or on nasal continuous positive airway pressure at 5 to 6 cmH2P with and FiO2 requirement </= 40% by the clinical care team for clinical care purposes.
  • On current mode of support for >/= 12 hours and have been extubated from a mechanical ventilator for >/= 48 hours.

Exclusion Criteria:

  • Infants with skeletal or neuromuscular disorders that affect the accuracy of RIP PFT measurements.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531465

Contacts
Contact: Beatriz de Jongh, MD 302-733-2410 bdejongh@nemours.org
Contact: Amy B Mackley, MSN, RNC, CCRC 302-733-2153 amackley@christianacare.org

Locations
United States, Delaware
Christiana Care Health System - Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Principal Investigator: Beatriz de Jongh, MD            
Sub-Investigator: Robert Locke, DO            
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: Beatriz de Jongh, MD Christiana Care Health Systems
Study Director: Robert Locke, DO Christiana Care Health System
  More Information

No publications provided

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT01531465     History of Changes
Other Study ID Numbers: 31073
Study First Received: May 25, 2011
Last Updated: October 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Respiratory insufficiency
Infants
High Flow Nasal Cannula (HFNC)
Nasal Continuous Positive Airway Pressure (NCPAP)

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013