High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01531465 |
|
Recruitment Status :
Completed
First Posted : February 13, 2012
Last Update Posted : June 4, 2013
|
Sponsor:
Christiana Care Health Services
Information provided by (Responsible Party):
Christiana Care Health Services
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Respiratory Insufficiency | Other: Pulmonary Function Testing & esophageal pressure monitoring Other: Pulmonary function testing and esophageal pressure | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (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) |
| Study Start Date : | June 2011 |
| Actual Primary Completion Date : | October 2012 |
| Actual Study Completion Date : | January 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Respiratory Failure
| Arm | Intervention/treatment |
|---|---|
|
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:
|
|
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:
|
Primary Outcome Measures :
- lung compliance [ Time Frame: 2 hours ]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)?
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 6 Months (Child) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531465
Locations
| United States, Delaware | |
| Christiana Care Health System - Christiana Hospital | |
| Newark, Delaware, United States, 19718 | |
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 Services |
| Responsible Party: | Christiana Care Health Services |
| ClinicalTrials.gov Identifier: | NCT01531465 |
| Other Study ID Numbers: |
31073 |
| First Posted: | February 13, 2012 Key Record Dates |
| Last Update Posted: | June 4, 2013 |
| Last Verified: | June 2013 |
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 Pulmonary Valve Insufficiency Respiration Disorders Respiratory Tract Diseases |
Heart Valve Diseases Heart Diseases Cardiovascular Diseases |