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

Not Applicable

Completed

• Conditions: Extubation Failure
• Interventions: Device: Bubble CPAP; Device: Conventional CPAP

• Registration Number: NCT00979433
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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.

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-23
• Last Update Posted: 2013-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bubble CPAP	Bubble CPAP	All neonates randomised to bubble CPAP will be put on Bubble CPAP following initial extubation in first week of life.
Conventional CPAP	Conventional CPAP	All neonates randomly allocated to conventional/ventilator derived CPAP.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time to extubation failure in hours.	till extubation failure within first 72 hours after extubation

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 New Delhi, Delhi, India