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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00979433

Enrollment

Registered

2009-09-18

Start date

2007-09-30

Completion date

2009-11-30

Last updated

2013-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extubation Failure

Keywords

Extubation failure, Continuous positive airway pressure, Bubble CPAP

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.

Interventions

DEVICEBubble 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%.

DEVICEConventional 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 7 Days

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	Time frame
Time to extubation failure in hours.	till extubation failure within first 72 hours after extubation

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026