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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bubble CPAP vs. Conventional CPAP Following Extubation in Preterm Very Low Birth Weight (VLBW) Infants: A Randomized Controlled Trial

Conditions
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Extubation Failure

Intervention / Treatment
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* Device: Bubble CPAP
* Device: Conventional CPAP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bubble CPAP<br>All neonates randomised to bubble CPAP will be put on Bubble CPAP following initial extubation in first week of life. | Device: Bubble CPAP<br>* 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%.<br>* Other names: Fisher & Paykel Bubble CPAP System;|
| Other: Conventional CPAP<br>All neonates randomly allocated to conventional/ventilator derived CPAP. | Device: Conventional CPAP<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to extubation failure in hours. |  | till extubation failure within first 72 hours after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extubation failure, Continuous positive airway pressure, Bubble CPAP