- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00979433
Bubble Continuous Positive Airway Pressure (CPAP) With Conventional CPAP for Extubation in Preterm Infants
February 23, 2013 updated by: Ramesh K Agarwal, All India Institute of Medical Sciences, New Delhi
Bubble CPAP vs. Conventional CPAP Following Extubation in Preterm Very Low Birth Weight (VLBW) Infants: A Randomized Controlled Trial
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Delhi
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New Delhi, Delhi, India
- All India Institute of Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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 Names:
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Other: Conventional CPAP
All neonates randomly allocated to conventional/ventilator derived CPAP.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Till 72 hours after extubation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to extubation failure in hours.
Time Frame: till extubation failure within first 72 hours after extubation
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till extubation failure within first 72 hours after extubation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
September 17, 2009
First Submitted That Met QC Criteria
September 17, 2009
First Posted (Estimate)
September 18, 2009
Study Record Updates
Last Update Posted (Estimate)
February 26, 2013
Last Update Submitted That Met QC Criteria
February 23, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- A-74
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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