Bubble Continuous Positive Airway Pressure (CPAP) With Conventional CPAP for Extubation in Preterm Infants
The objective of this study is to evaluate whether CPAP delivered by bubble CPAP resulted in a greater proportion of infants being successfully extubated when compared with management with ventilator derived CPAP.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Bubble CPAP vs. Conventional CPAP Following Extubation in Preterm Very Low Birth Weight (VLBW) Infants: A Randomized Controlled Trial|
- 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 ] [ Designated as safety issue: No ]
- Time to extubation failure in hours. [ Time Frame: till extubation failure within first 72 hours after extubation ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
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.
There have been no published randomized trials comparing extubation failure rates of Bubble CPAP with conventional ventilator derived CPAP. Infants of gestation <32 weeks and of birth weight less than 1500 grams considered by the treating team to be ready for the initial extubation within first week of life were screened for enrolment. All eligible neonates were randomly allocated to bubble CPAP or conventional CPAP.The purpose of this study is to compare whether infants on Bubble CPAP had more chances of successful extubation as compared to infants put on Conventional CPAP.
Please refer to this study by its ClinicalTrials.gov identifier: 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|