Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support
|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Recruitment Status : Withdrawn (PI has left Institution)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|
|Respiratory Distress Syndrome Prematurity||Device: Nasal CPAP Device: Oscillatory NCPAP|
|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.
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|