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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Extubation Failure	Device: Bubble CPAP; Device: Conventional CPAP	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	32 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	September 2007
Actual Primary Completion Date :	November 2009
Actual Study Completion Date :	November 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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
Conventional CPAP; 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.

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Time to extubation failure in hours. [ Time Frame: till extubation failure within first 72 hours after extubation ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 7 Days (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Gestation less than 32 weeks
• Birth weight less than 1500 g
• Age less than seven days
• First extubation attempt.

Exclusion Criteria:

• A neonate having any of the following will be excluded from the study-
• Severe birth asphyxia defined as need for chest compression for more than 30 seconds
• Suspected congenital neuromuscular disorder
• Major congenital malformation
• Grade 3/4 interventricular haemorrhage
• Hydrops.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

India
All India Institute of Medical Sciences
New Delhi, Delhi, India

Sponsors and Collaborators

All India Institute of Medical Sciences, New Delhi

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ramesh K Agarwal, Associate Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:	NCT00979433 History of Changes
Other Study ID Numbers:	A-74
First Posted:	September 18, 2009
Last Update Posted:	February 26, 2013
Last Verified:	February 2013

Keywords provided by Ramesh K Agarwal, All India Institute of Medical Sciences, New Delhi:

Extubation failure; Continuous positive airway pressure; Bubble CPAP