Bubble Continuous Positive Airway Pressure (CPAP) With Conventional CPAP for Extubation in Preterm Infants
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|ClinicalTrials.gov Identifier: NCT00979433|
Recruitment Status : Completed
First Posted : September 18, 2009
Last Update Posted : February 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Extubation Failure||Device: Bubble CPAP Device: Conventional CPAP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bubble CPAP vs. Conventional CPAP Following Extubation in Preterm Very Low Birth Weight (VLBW) Infants: A Randomized Controlled Trial|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
Experimental: Bubble CPAP
All neonates randomised to bubble CPAP will be put on Bubble CPAP following initial extubation in first week of life.
Device: Bubble CPAP
Bubble CPAP will be delivered using Fischer & Paykel CPAP system with a starting flow of 6 liters/minute. CPAP will be initially started at a pressure of 5 - 6 cm H2O and fraction of inspired oxygen (FiO2) of 0.4 - 0.5. which will be adjusted to maintain oxygen saturation (SpO2) between 87 and 93%.
Other Name: Fisher & Paykel Bubble CPAP System
All neonates randomly allocated to conventional/ventilator derived CPAP.
Device: Conventional CPAP
Conventional CPAP will be delivered using Argyle CPAP (Sherwood Medical Company, Mexico) short nasal prongs with warm, humidified gas used (34-37°C) through a thermo-statically controlled humidifier, flow @ 4-8 L/min from either SLE 2000 pressure-controlled continuous flow ventilator (Specialized Laboratory Equipment, UK) or Baby log 8000 volume guarantee ventilator.
- Extubation failure - defined as need for reintubation and mechanical ventilation for any reason within 72 hours of initial extubation [ Time Frame: Till 72 hours after extubation ]
- Time to extubation failure in hours. [ Time Frame: till extubation failure within first 72 hours after extubation ]
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): NCT00979433
|All India Institute of Medical Sciences|
|New Delhi, Delhi, India|
|Study Chair:||Vinod K Paul, MD PhD||Department of Pediatrics, All India Institute of Medical Sciences, New Delhi|
|Principal Investigator:||Sucheta Yadav, MBBS||Department of Pediatrics, All India Institute of Medical Sciences, New Delhi|
|Study Chair:||Mari J Sankar, MD, DM||Department of Pediatrics, All India Institute of Medical Sciences, New Delhi|
|Study Chair:||Ramesh Agarwal, MD, DM||Department of Pediatrics, All India Institute of Medical Sciences, New Delhi|