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

September 17, 2009
February 23, 2013
September 2007
November 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00979433 on ClinicalTrials.gov Archive Site
Time to extubation failure in hours. [ Time Frame: till extubation failure within first 72 hours after extubation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bubble Continuous Positive Airway Pressure (CPAP) With Conventional CPAP for Extubation in Preterm Infants
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Extubation Failure
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
up to 7 Days
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00979433
A-74
No
Ramesh K Agarwal, All India Institute of Medical Sciences, New Delhi
All India Institute of Medical Sciences, New Delhi
Not Provided
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
All India Institute of Medical Sciences, New Delhi
February 2013

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