An interventional study of Bubble CPAP and Conventional CPAP in Extubation Failure, sponsored by All India Institute of Medical Sciences. Completed at 1 site in India. Open to participants aged Up to 7 Days. Per ClinicalTrials.gov, last updated 2013-02-26.
Sponsored by All India Institute of Medical Sciences · Not applicable, Interventional, and Prevention
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.
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.
All India Institute of Medical Sciences is the lead sponsor of 27 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
All neonates randomised to bubble CPAP will be put on Bubble CPAP following initial extubation in first week of life.
Device: Bubble CPAP
All neonates randomly allocated to conventional/ventilator derived CPAP.
Device: Conventional 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%.
Also known as: Fisher & Paykel Bubble CPAP System
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
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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All India Institute of Medical Sciences