Bubble Continuous Positive Airway Pressure (CPAP) With Conventional CPAP for Extubation in Preterm Infants
This study has been completed.
Sponsor:
All India Institute of Medical Sciences, New Delhi
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
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Purpose
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 | Intervention |
|---|---|
|
Extubation Failure |
Device: Bubble CPAP Device: Conventional CPAP |
| Study Type: | Interventional |
| 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 |
Further study details as provided by All India Institute of Medical Sciences, New Delhi:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Time to extubation failure in hours. [ Time Frame: till extubation failure within first 72 hours after extubation ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | September 2007 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | up to 7 Days (Child) |
| Genders Eligible for Study: | Both |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00979433
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979433
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
| 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 |
| Study First Received: | September 17, 2009 |
| Last Updated: | February 23, 2013 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by All India Institute of Medical Sciences, New Delhi:
|
Extubation failure Continuous positive airway pressure Bubble CPAP |
ClinicalTrials.gov processed this record on September 23, 2016