Back to resultsHigh Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure
Primary Purpose
Respiratory Insufficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulmonary Function Testing & esophageal pressure monitoring
Pulmonary function testing and esophageal pressure
Sponsored by
About this trial
This is an interventional basic science trial for Respiratory Insufficiency focused on measuring Respiratory insufficiency, Infants, High Flow Nasal Cannula (HFNC), Nasal Continuous Positive Airway Pressure (NCPAP)
Eligibility 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.
Sites / Locations
- Christiana Care Health System - Christiana Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
HFNC to NCPAP
NCPAP to HFNC
Arm Description
Infants who are currently on HFNC.
Infants who are currently on NCPAP.
Outcomes
Primary Outcome Measures
lung compliance
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)?
Secondary Outcome Measures
Full Information
NCT ID
NCT01531465
First Posted
May 25, 2011
Last Updated
June 3, 2013
Sponsor
Christiana Care Health Services
1. Study Identification
Unique Protocol Identification Number
NCT01531465
Brief Title
High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure
Official Title
Pulmonary Function Testing in Infants With Respiratory Insufficiency While Receiving High Flow Nasal Cannula (HFNC) Versus Nasal Continuous Positive Airway Pressure (nCPAP)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Respiratory insufficiency, Infants, High Flow Nasal Cannula (HFNC), Nasal Continuous Positive Airway Pressure (NCPAP)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HFNC to NCPAP
Arm Type
Other
Arm Description
Infants who are currently on HFNC.
Arm Title
NCPAP to HFNC
Arm Type
Other
Arm Description
Infants who are currently on NCPAP.
Intervention Type
Other
Intervention Name(s)
Pulmonary Function Testing & esophageal pressure monitoring
Other Intervention Name(s)
Pulmonary Function Testing, Esophageal pressure
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pulmonary function testing and esophageal pressure
Other Intervention Name(s)
Pulmonary Function Testing, Esophageal pressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
lung compliance
Description
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)?
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz de Jongh, MD
Organizational Affiliation
Christiana Care Health Systems
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Locke, DO
Organizational Affiliation
Christiana Care Health Services
Official's Role
Study Director
Facility Information:
Facility Name
Christiana Care Health System - Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
12. IPD Sharing Statement
Learn more about this trial
High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure
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