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
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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 July 20, 2014