Bubble Continuous Positive Airway Pressure (CPAP) With Conventional CPAP for Extubation in Preterm Infants
|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 ]
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|