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

All India Institute of Medical Sciences32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Extubation Failure

Interventions

Bubble CPAPDEVICE

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%.

Conventional CPAPDEVICE

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.

Eligibility

Sex: ALLMax age: 7 Days

Medical Language ↔ Plain English

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.

Locations (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

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

Secondary Outcomes

Time to extubation failure in hours.

Time frame: till extubation failure within first 72 hours after extubation

Data from ClinicalTrials.gov

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