Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support
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|ClinicalTrials.gov Identifier: NCT01277874|
Recruitment Status : Withdrawn (PI has left Institution)
First Posted : January 17, 2011
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome Prematurity||Device: Nasal CPAP Device: Oscillatory NCPAP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||April 2017|
Active Comparator: Nasal CPAP
Standard Nasal CPAP
Device: Nasal CPAP
NCPAP is delivered via nasal prongs placed into infant's nares. It may be delivered via ventilator or by bubble.
Active Comparator: Oscillatory NCPAP
NCPAP will be given to infant via prongs in the infant's nose. A Bird Industries pneumatic oscillating diaphragm to drive a Bird Industries phasatron which is attached by T-connector to the NCPAP patient circuit.
Device: Oscillatory NCPAP
Bird Industries pneumatic diaphragm is attached to NCPAP patient circuit to provide oscillations.
Other Name: Bird Industries
- Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP [ Time Frame: 2 months ]Determine the physiologic respiratory stability (pCO2, respiratory rate, apnea frequency) during treatment with NCPAP
- Need for mechanical ventilation following the initiation of NCPAP. [ Time Frame: 2 months ]The rate of mechanical ventilation following both Oscillating and Non-Oscillating groups.
- Total duration of non-invasive and invasive respiratory support in each study group. [ Time Frame: 2 months ]Determine the total duration of non-invasive and invasive respiratory support in each study group.
- total amount of oxygen exposure in each study group. Total amount of oxygen exposure in each study group. [ Time Frame: 2 months ]Determine the total amount of oxygen exposure in each study group.
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): NCT01277874
|United States, California|
|Valley Children's Healthcare|
|Madera, California, United States, 93636|
|United States, Utah|
|Primary Children's Medical Center|
|Salt Lake City, Utah, United States, 84113|
|University of Utah Health Sciences Center|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Donald Null, MD||University of Utah|