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

NCT00979433 | Completed

• 1 other identifier: A-74
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Extubation Failure

Keywords

Extubation failure; Continuous positive airway pressure; Bubble CPAP

Outcome Measures

Primary Outcomes (1)

• Extubation failure - defined as need for reintubation and mechanical ventilation for any reason within 72 hours of initial extubation

  Till 72 hours after extubation

Secondary Outcomes (1)

• Time to extubation failure in hours.

  till extubation failure within first 72 hours after extubation

Study Arms (2)

Bubble CPAP

EXPERIMENTAL

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

Device: Bubble CPAP

Conventional CPAP

OTHER

All neonates randomly allocated to conventional/ventilator derived CPAP.

Device: Conventional CPAP

Interventions

Bubble CPAP DEVICE

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%.

Also known as: Fisher & Paykel Bubble CPAP System

Bubble CPAP

Conventional CPAP DEVICE

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.

Conventional CPAP

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestation less than 32 weeks
• Birth weight less than 1500 g
• Age less than seven days
• First extubation attempt.

You may not qualify if:

• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Location

Study Officials

• Vinod K Paul, MD PhD

  Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

  STUDY CHAIR

• Sucheta Yadav, MBBS

  Department of Pediatrics, All India Institute of Medical Sciences, New Delhi

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: September 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

IN (1)