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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ramesh K Agarwal, All India Institute of Medical Sciences, New Delhi

ClinicalTrials.gov Identifier:

NCT00979433

First received: September 17, 2009

Last updated: February 23, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 17, 2009

Last Updated Date

February 23, 2013

Start Date ^ICMJE

September 2007

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00979433 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to extubation failure in hours. [ Time Frame: till extubation failure within first 72 hours after extubation ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Bubble CPAP vs. Conventional CPAP Following Extubation in Preterm Very Low Birth Weight (VLBW) Infants: A Randomized Controlled Trial

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.

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Extubation Failure

Intervention ^ICMJE

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
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.

Study Arm (s)

Experimental: Bubble CPAP
All neonates randomised to bubble CPAP will be put on Bubble CPAP following initial extubation in first week of life.

Intervention: Device: Bubble CPAP
Conventional CPAP
All neonates randomly allocated to conventional/ventilator derived CPAP.

Intervention: Device: Conventional CPAP

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2009

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

up to 7 Days

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

India

Administrative Information

NCT Number ^ICMJE

NCT00979433

Other Study ID Numbers ^ICMJE

A-74

Has Data Monitoring Committee

Responsible Party

Ramesh K Agarwal, All India Institute of Medical Sciences, New Delhi

Study Sponsor ^ICMJE

All India Institute of Medical Sciences, New Delhi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

All India Institute of Medical Sciences, New Delhi

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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